Protocol for a Dietitian-Led Group Education Programme for Irish Males with Metastatic Genitourinary Cancer: The Men’s Health Initiative LIAM Mc Trial

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Treatments such as androgen deprivation therapy negatively affect body composition, including muscle loss and fat gain. Group-based education with peer support, particularly when led by dietitians, is valued by prostate cancer survivors and may support positive behaviour change. Aim This protocol outlines the dietetic component of the Linking In with supports and Advice for Males impacted by Metastatic Cancer (LIAM Mc) Trial (NCT05946993) and describes the approach to assessing its feasibility in men with advanced or metastatic genitourinary cancer. Methods The LIAM Mc Trial is a 12-week multidisciplinary intervention for men aged ≥18 years with advanced or metastatic genitourinary cancer. The dietetic component includes five structured group education sessions based on the World Cancer Research Fund Recommendations and the Healthy Ireland Food Pyramid. One-on-one nutritional counselling is also offered. Dietary quality will be assessed via a cancer-specific dietary quality score and body composition will be assessed using bioelectrical impedance analysis, and ultrasound. Feasibility outcomes include recruitment, retention, attendance, acceptability, and the practicality of collecting outcome data. Conclusion This study will provide feasibility data to inform the future scaling of dietitian-led group education for men with metastatic cancer. It will also offer insights into the acceptability and potential impact of such interventions on diet quality and body composition, informing the design of a future definitive trial and contributing to models of survivorship care that prioritise nutrition and peer support. Clinical Trials Registration ClinicalTrials.gov (NCT05946993), registered on 10th May 2023, and Cancer Trials Ireland (CTRIAL-IE 23-18). " } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://hrbopenresearch.org/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://hrbopenresearch.org/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://hrbopenresearch.org/articles/9-10/v1", "name": "Protocol for a Dietitian-Led Group Education Programme for Irish Males..." } } ] } Home Browse Protocol for a Dietitian-Led Group Education Programme for Irish Males... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Johnston KE, Cushen SJ, Muldoon F et al. Protocol for a Dietitian-Led Group Education Programme for Irish Males with Metastatic Genitourinary Cancer: The Men’s Health Initiative LIAM Mc Trial [version 1; peer review: 1 approved with reservations] . HRB Open Res 2026, 9 :10 ( https://doi.org/10.12688/hrbopenres.14267.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Protocol for a Dietitian-Led Group Education Programme for Irish Males with Metastatic Genitourinary Cancer: The Men’s Health Initiative LIAM Mc Trial [version 1; peer review: 1 approved with reservations] Katie E Johnston https://orcid.org/0000-0003-0772-2703 1,2 , Samantha J Cushen https://orcid.org/0000-0001-8594-9140 2 , Fionnuala Muldoon 3 , [...] Laia Raigal-Aran 1 , Katarina Medved https://orcid.org/0009-0004-8097-6659 1 , Stephanie Corkery 4 , Anita Cahill 5 , Christine Allan 6 , Brendan Noonan 7 , Jack P Gleeson https://orcid.org/0000-0001-6908-495X 1,8 Katie E Johnston https://orcid.org/0000-0003-0772-2703 1,2 , Samantha J Cushen https://orcid.org/0000-0001-8594-9140 2 , [...] Fionnuala Muldoon 3 , Laia Raigal-Aran 1 , Katarina Medved https://orcid.org/0009-0004-8097-6659 1 , Stephanie Corkery 4 , Anita Cahill 5 , Christine Allan 6 , Brendan Noonan 7 , Jack P Gleeson https://orcid.org/0000-0001-6908-495X 1,8 PUBLISHED 15 Jan 2026 Author details Author details 1 Cancer Research @UCC, College of Medicine and Health, University College Cork, Cork, County Cork, Ireland 2 Clinical Nutrition and Oncology Research Group, School of Food and Nutritional Sciences, University College Cork, Cork, County Cork, Ireland 3 Department of Clinical Nutrition and Dietetics, South Infirmary Victoria University Hospital, Cork, County Cork, Ireland 4 Department of Physiotherapy, Cork University Hospital, Cork, County Cork, Ireland 5 Department of Urology, Cork University Hospital, Cork, County Cork, Ireland 6 HRB Clinical Research Facility, School of Public Health, University College Cork, Cork, County Cork, Ireland 7 Catherine McAuley School of Nursing and Midwifery, University College Cork, Cork, County Cork, Ireland 8 CUH/UCC Cancer Centre, Cork University Hospital, Cork, County Cork, Ireland Katie E Johnston Roles: Investigation, Methodology, Project Administration, Resources, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Samantha J Cushen Roles: Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Fionnuala Muldoon Roles: Conceptualization, Writing – Review & Editing Laia Raigal-Aran Roles: Project Administration, Writing – Review & Editing Katarina Medved Roles: Project Administration, Writing – Review & Editing Stephanie Corkery Roles: Conceptualization, Writing – Review & Editing Anita Cahill Roles: Conceptualization, Writing – Review & Editing Christine Allan Roles: Project Administration, Software, Writing – Review & Editing Brendan Noonan Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing Jack P Gleeson Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS Abstract Background Over 100,000 men in Ireland are living with or beyond a cancer diagnosis, many with complex and evolving needs. Treatments such as androgen deprivation therapy negatively affect body composition, including muscle loss and fat gain. Group-based education with peer support, particularly when led by dietitians, is valued by prostate cancer survivors and may support positive behaviour change. Aim This protocol outlines the dietetic component of the Linking In with supports and Advice for Males impacted by Metastatic Cancer (LIAM Mc) Trial (NCT05946993) and describes the approach to assessing its feasibility in men with advanced or metastatic genitourinary cancer. Methods The LIAM Mc Trial is a 12-week multidisciplinary intervention for men aged ≥18 years with advanced or metastatic genitourinary cancer. The dietetic component includes five structured group education sessions based on the World Cancer Research Fund Recommendations and the Healthy Ireland Food Pyramid. One-on-one nutritional counselling is also offered. Dietary quality will be assessed via a cancer-specific dietary quality score and body composition will be assessed using bioelectrical impedance analysis, and ultrasound. Feasibility outcomes include recruitment, retention, attendance, acceptability, and the practicality of collecting outcome data. Conclusion This study will provide feasibility data to inform the future scaling of dietitian-led group education for men with metastatic cancer. It will also offer insights into the acceptability and potential impact of such interventions on diet quality and body composition, informing the design of a future definitive trial and contributing to models of survivorship care that prioritise nutrition and peer support. Clinical Trials Registration ClinicalTrials.gov (NCT05946993), registered on 10 th May 2023, and Cancer Trials Ireland (CTRIAL-IE 23-18). READ ALL READ LESS Keywords Prostate Cancer, Genitourinary Cancer, Metastatic Cancer, Dietary Intervention, Body Composition, Cancer Survivorship, Feasibility Study Corresponding Author(s) Katie E Johnston ( [email protected] ) Close Corresponding author: Katie E Johnston Competing interests: Jack Gleeson receives funding support through a philanthropic donation from UPMC towards protected research time, during which this work was completed. Katie E Johnston was supported by the Irish Cancer Society’s Research Networking Award, which facilitated specialist training that was subsequently incorporated into this study as a Study Within A Trial (SWAT). The other co-authors have no conflicts of interest to declare. Grant information: Health Research Board Ireland CTIC-2021-002 (UCC Cancer Trials Group). This work was also supported by Irish Cancer Society (MHI22BAM & SCRNA22JOH). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2026 Johnston KE et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Johnston KE, Cushen SJ, Muldoon F et al. Protocol for a Dietitian-Led Group Education Programme for Irish Males with Metastatic Genitourinary Cancer: The Men’s Health Initiative LIAM Mc Trial [version 1; peer review: 1 approved with reservations] . HRB Open Res 2026, 9 :10 ( https://doi.org/10.12688/hrbopenres.14267.1 ) First published: 15 Jan 2026, 9 :10 ( https://doi.org/10.12688/hrbopenres.14267.1 ) Latest published: 15 Jan 2026, 9 :10 ( https://doi.org/10.12688/hrbopenres.14267.1 ) Introduction Improvements in 5-year net survival means that there are more people living with and beyond a cancer diagnosis, often referred to as “cancer survivors” 1 . The National Cancer Institute defines an individual as a cancer survivor from the time of diagnosis through the balance of life 2 . Cancer survivorship occurs in phases related to the goal of care; for those diagnosed with advanced or metastatic cancer, the goal is to treat with the intent to prolong life 2 . In Ireland, 48% (n=104,065) of cancer survivors are male 1 . The 5-year net survival from all cancers, excluding non-melanoma skin cancer (NMSC), in males has improved by 25.1% over the last 20 years 1 . Prostate cancer accounted for 30% of all male invasive cancers (excluding NMSC) diagnosed from 2019-2021, but also accounted for 21% of cancer deaths during this period. 1 . Ireland’s National Cancer Control Programme’s (NCCP) National Cancer Strategy 2017 – 2026 identifies cancer survivorship as a distinct and important phase in the cancer care continuum 3 . People living with and beyond a cancer diagnosis have a unique set of needs that surpass the completion of their primary treatment, such as chemotherapy or radiotherapy, and are multifaceted and complex. The needs include the management of a wide range of symptoms, including physiological, psychological, sexual, cognitive, physical and nutritional challenges 4 , 5 . These symptoms may be equal or more disabling than the cancer diagnosis itself and its treatment and can significantly affect quality of life (QoL). A scoping review published in 2019 reported that it was clear the needs of people living with and beyond cancer in Ireland are currently not being met 6 . The NCCP recommended that survivorship care programmes should be tailored to address specific needs of individual cancer survivors, as one size does not fit all 3 . The National Comprehensive Cancer Network’s (NCCN) Survivorship Guidelines recommend that a multi-disciplinary approach is used 7 . Consistent evidence has reported the importance of dietetic input within the cancer care multi-disciplinary team (MDT), due to its positive impact on clinically relevant outcomes, including reduction of treatment toxicity and increasing progression free survival and overall survival 8 . Unfortunately, nutritional deterioration has become an accepted part of the pathogenesis of cancer and its treatment, and changes in nutrition status can occur at any point of the cancer care continuum, not solely during treatment 8 . The European Society of Clinical Nutrition and Metabolism (ESPEN) highlight that nutrition plays a crucial role in multimodal cancer care, recommending that cancer survivors maintain a healthy weight and follow a plant-based, low-fat diet 9 . The recommendation also acknowledges the needs of patients with advanced cancer receiving no anti-cancer treatment, defined as “palliative patients” 9 . The life expectancy of these patients may be several months to several years and deficits in nutritional status may impair performance status, QoL, tolerance to anti-cancer treatments and survival; therefore, screening and assessment by a dietitian is advised (Recommendation 41) 9 . The Nutrition and Physical Activity Guidelines for Cancer Survivors from Rock et al. (2012) and the American Cancer Society (ACS) highlight that individuals who have been diagnosed with cancer are at a significantly higher risk of developing second primary cancers and are at an increased risk for chronic disease such as cardiovascular disease, diabetes and osteoporosis 4 . While individuals with cancer are advised to follow healthy dietary patterns to reduce the risk of secondary cancers and chronic disease 4 the World Cancer Research Fund notes that current evidence is still insufficient to make specific, confident nutritional recommendations for survivors 10 . However, their general Cancer Prevention Guidelines are considered safe and potentially beneficial for those who have completed treatment 10 . Androgen Deprivation Therapy (ADT), the most common hormonal treatment for prostate cancer, has expanded rapidly—especially for metastatic castration-sensitive cases 11 . Beyond the effects of chemoradiation, ADT can lead to altered body composition and significant deconditioning in men living with and beyond a prostate cancer diagnosis 4 , 12 – 16 . Body composition changes can occur throughout treatment, with studies showing a 2–4% decrease in muscle mass with a concomitant 14% increase in fat mass after 36 weeks of ADT 12 , 14 . Sarcopenia affects up to 52% of prostate cancer patients 17 and these body composition changes may increase the risk of ADT-induced sarcopenic obesity and adverse outcomes 18 . Although patients may seem “well-nourished” by BMI, altered body composition, irrespective of baseline BMI, leads to lower function, quality of life, survival, and increased chemotherapy toxicity 17 . ADT may also accelerate bone loss, up to ten times faster than normal 18 . Altered body composition and its consequences highlight the need for targeted support. Dietetic group education has proven effective in other chronic conditions like diabetes and cardiac rehab 19 – 21 . Yet, more than 60% of health professionals highlighted a need for prostate-cancer specific nutrition services 22 especially since less than a third of men make lifestyle changes after diagnosis 23 . Despite this, specialist oncology dietetic group education for men with cancer remains rare in Ireland, with limited local research on nutrition during maintenance treatment. Building on the need for specialist dietetic support, a shortage of registered dietitians in Ireland has been reported 24 . A 2021 study of over 1000 oncology survivors, 36% of whom were males with metastatic disease, found that although survivors value nutrition, only 39% had accessed dietetic care during their cancer journey 25 . Although the overarching LIAM Mc trial protocol has been published 26 , it provides only a broad overview of the study, with limited detail on the design and delivery of the dietetic component. Given the complexity and innovation involved in this dietary intervention, including structured group education, behaviour change strategies, and personalised follow-up, there is a clear need to describe the rationale, content, and implementation processes in greater depth. This is especially relevant in the context of Irish oncology care, where dedicated dietetic survivorship services are not yet formally integrated into the healthcare system. By sharing a focused dietetic protocol, this manuscript aims to support replication, inform service development, and contribute to the growing body of evidence on scalable, patient-centred nutrition interventions for cancer survivors. The aim of this paper is to present the dietetic protocol for a group education programme led by a registered dietitian for males affected by metastatic genitourinary cancer, as part of the Men’s Health Initiative LIAM Mc Trial in Ireland. This paper also outlines the approach to assessing the feasibility of delivering the intervention and collecting relevant dietary and body composition outcome data. The working hypothesis is that a structured, dietitian-led group education programme, underpinned by evidence-based dietary guidelines and supported by peer interaction, will be acceptable to participants and feasible to implement in a survivorship setting for men with advanced cancer. Methodology Study design The LIAM Mc Trial is a single-arm, unblinded, 12-week interventional programme, led by a multidisciplinary team of allied healthcare professionals ( Figure 1 ). The programme will be delivered in a rehabilitation gym specially equipped for this intervention. A dietetic education series is embedded into the programme and participants have access to 1:1 personalised nutritional counselling sessions as required ( Figure 2 ). As this is a feasibility study, the primary aim is not to evaluate the effectiveness of the intervention but to assess the practicality of implementing a dietitian-led group education programme for men with metastatic genitourinary cancer. Figure 1. LIAM Mc Study Design. Figure 2. Participant Flow through the LIAM Mc Dietetic Component. The trial is conducted in accordance with the Declaration of Helsinki and the application sections of the ICH E6 Good Clinical Practices. As outlined in the main LIAM Mc protocol 26 , all future protocol amendments or modifications will be reviewed by the ethics committee. Eligible participants will receive verbal and written study information and have adequate time to consider participation before providing written informed consent at their initial assessment. Consent will be obtained by trained staff in accordance with the LIAM Mc protocol 26 . The trial received full ethical approval, granted by the Clinical Research Ethics Committee of the Cork University’s Teaching Hospital (ECM 4 [V] 01/11/2022). The trial is registered with ClinicalTrials.gov (NCT05946993) and Cancer Trials Ireland (CTRIAL-IE 23-18). The trial is funded by the Irish Cancer Society (MHI22BAM). Eligibility The LIAM Mc Trial is open to adult males diagnosed with advanced or metastatic genitourinary cancers, including prostate, urothelial tract, kidney, penile, and testicular cancers. Participants will be recruited from three hospitals within one Irish health service region. Eligibility will be assessed by the oncology clinical or research team. Inclusion and exclusion criteria are outlined in Table 1 and detailed on ClinicalTrials.gov (NCT05946993). Patients within the first three months of active systemic therapy will be excluded due to potential treatment-related barriers to participation but may be re-evaluated once stable or post-treatment. Table 1. LIAM Mc Inclusion and Exclusion Criteria. Inclusion Criteria Exclusion Criteria ≥ 18 years of age at the time of study enrolment Receiving systemic therapy for a concurrent cancer diagnosis Eastern Co-Operative Oncology Group (ECOG) performance status 0-2 Organ system dysfunction which would impact their safe participation in the study; Recovery to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤2 adverse events from all prior therapies, or adequately recovered adverse events whereby, whereby the PI feels they will not impact the participants ability to complete the 12-week intervention Other uncontrolled medical illness that would impact their safe participation in the study Patients commencing (in the first 3 months of active systemic therapy) which will impact their ability to participate in the programme are not eligible for the study Diagnosed with advanced or metastatic genitourinary cancer (disease-site specific criteria applies) Recent (within 12 months) participation in a study/programme involving a lifestyle intervention (e.g diet, exercise, survivorship) will be assessed as per discretion of PI as to whether may impact the outcome of this study intervention Sample size As this is a pilot study, a formal sample size calculation has not been conducted, as such calculations are typically unreliable due to uncertainty around key input parameters 27 . Instead, the sample size has been pragmatically set at 60 participants, based on published guidance that recommends this number to allow the detection of process-related issues—such as recruitment or retention failures—that might occur in 5% of cases, with 95% confidence 28 . To account for potential attrition due to withdrawal, illness, or loss to follow-up, the target sample size has been increased to 72 participants. Participants are grouped into cohorts of 6, with the intention of running 12 group cohorts through the programme. Data management Data is securely transferred between the Trial Master File and the community rehabilitation gym before and after each intervention session. Dietetic data is collected by the clinical research dietitian using approved case report forms (CRFs). Data is entered into an electronic data capture system (Castor Electronic Data Capture [EDC]) designed specifically for the LIAM Mc Trial. The Castor EDC meets international guidelines with respect to data protection standards. Nutritional information is analysed and stored using Nutritics nutritional analysis software ( www.nutritics.com ). All electronic data is encrypted, backed up monthly, and stored on a secure, password-protected device and within the Nutritics platform. Access to Nutritics and Castor EDC is restricted to authorised team members via role-based permissions. The ultrasound images are exported for each participant from the VScan Air software (GE Medical Systems Ultrasound and Primary Care Diagnostics, Wisconsin, US) and uploaded securely to the trial’s electronic Trial Master File (eTMF). Supplementary files are available via an Open Science Framework: https://doi.org/10.17605/OSF.IO/ZBCSM 29 . Participants are assigned a unique study ID used on all CRFs, stored separately from personal data. Only authorised team members can access identifiable information. Study data will be checked for errors or inconsistencies and verified against source data. Once cleaned, the Castor EDC database will be locked. Source data, including dietetic CRFs, will be filed in participants’ medical records per hospital guidelines. At study completion, anonymised data will be available to the principal statistician and authorised researchers. Data collection will conclude in December 2025. Statistical analysis Quantitative analysis Statistical analysis will be completed and/or supervised by a biostatistician. After final data entry, the dataset will be reviewed for outliers or discrepancies, which will be checked against source data. Once cleaned, the database will be locked. The study sample will be summarised using appropriate descriptive statistics: means (SD), medians (IQR), ranges for continuous variables, and counts (%) for categorical variables. Missing data will be handled according to best practice. Analyses will be conducted using R and RStudio. Feasibility outcomes will be analysed descriptively, in accordance with CONSORT guidelines for pilot and feasibility studies 30 . These outcomes will include recruitment rates, retention rates, attendance at group sessions, completion of outcome assessments, and uptake of one-on-one dietetic counselling. Acceptability of the intervention will be explored using participant feedback and qualitative data collected during and after the intervention. Where appropriate, 95% confidence intervals will be reported for key feasibility indicators to inform the design and planning of a future definitive trial. Qualitative analysis Full details of the qualitative analysis methodology have been described elsewhere 26 . Briefly, qualitative data will be analysed using thematic analysis , with NVivo software used to support data management and coding. Qualitative findings will be integrated with quantitative feasibility data to provide a comprehensive understanding of the implementation process, including participant experiences, acceptability of the intervention, and contextual factors influencing engagement. Baseline, endpoint and 6 month follow up measurements Table 2 describes the schedule of dietetic measurements over the intervention period. Table 2. Dietetic Schedule of Body Composition and Nutritional Assessments. Measurement Baseline (Week 0) Endpoint (Week 12) 6 Month Follow Up (Week 24) Weight, Height and BMI x x Waist Circumference x x Handgrip Strength x x Body Composition (BIA) including LTM, LTI, FM, FTI & ATM x x Body Composition (Ultrasound) including MT & PA x x Multiple 24HR Dietary Recall x x WCRF/AICR Diet Quality Score x x Food Frequency Questionnaire x x MST Score x x BIA: Bioelectrical Impedance Analysis, LTM: Lean Tissue Mass, LTI: Lean Tissue Index, FM: Fat Mass, FTI: Fat Tissue Index, ATM: Adipose Tissue Mass, MT: Muscle Thickness, PA: Pennation Angle, WCRF: World Cancer Research Fund, AICR: American Institute for Cancer Research, MST: Malnutrition Screening Tool Body Mass Index: BMI is calculated by the participant’s weight in kg to the nearest 0.1kg, using the SECA Model 799 weighing scales, and their height in metres to the 0.01m, using SECA 206 stadiometer. Waist Circumference: Waist circumference is measured to the nearest 0.1cm following the WHO STEPS Manual 31 . The measurement is conducted three times, and the mean value is used. Body Composition: Body composition is measured using the Fresenius Kabi Body Composition Monitor (BCM, Fresenius Medical Care, Bad Homburg, Germany). Measurements include lean tissue mass, lean tissue index, adipose tissue mass, fat tissue index, total body water, body cell mass, extracellular water and intracellular water. Participants who have pacemakers, implanted electronic devices are excluded from this measurement. The quality value for each measurement aims to be > 85 out of 100. Ultrasound Assessment of Muscle Mass: Muscle mass is measured using a VScan Air portable ultrasound. The rectus femoris is used as per the SARCUS Group 2021 recommendations 32 . Measurements are obtained at 50% of the distance between the greater trochanter and proximal patella of each leg. For participants whose rectus femoris is too large to image, measurements are obtained at 30% from the proximal patella. Muscle thickness (mm) and pennation angle (o) are measured taken three times on each leg and an average is calculated. Handgrip Strength: Handgrip strength is measured using Jamar dynamometer (Jamar Hydraulic Hand Dynamometer, Model 091011725, Sammons Preston Roylan, Nottinghamshire, UK), using the second handle position as recommended by the American Society of Hand Therapists. The measurement is taken three times on each hand, alternating each measurement to allow a break. Multiple 24-Hour Dietary Recall: Two 24-hour dietary recalls (weekday and weekend) are collected at baseline and endpoint. The dietitian will assign food codes to each item reported, with analysis limited to McCance & Widdowson, USDA, and Irish food composition databases 33 – 35 . A food code database will be created and updated with each new 24-hour recall. Data will be analysed using Nutritics software to assess macro- and micronutrients and dietary quality based on the WCRF cancer prevention framework. Comparisons will be made within and between individuals 36 . All reference data will be assessed within-individual comparison and between-individual comparison. Food Frequency Questionnaire: Individual and collective sample data captured from the EPIC-Norfolk Food Frequency Question (FFQ) will be entered into the FFQ processing tool, FETA (Φετα) FFQ EPIC Tool for Analysis, which is based on the earlier CAFÉ system 37 . The FETA tool is free to use and will produce different levels of nutrient data, as well as basic food groups and food patterns. This programme is based on version 6 (CAMB/PQ/6/1205) of the EPIC-Norfolk Food Frequency Questionnaire. FETA calculates the average daily intake of 46 nutrients and 14 food groups, for each individual. The default nutrients list provides a description of each nutrient/food group and the units used. The nutrient data for the FFQ foods have come from McCance and Widdowson’s “The Composition of Foods (5th edition)” 33 . In FETA, the frequency category is converted into a portion multiplier (e.g. once a week = 1/7 = 0.14). After multiplication with the portion size, an average daily food weight for each of the 130 FFQ items is obtained. These weights are multiplied by the nutrient composition per gram to obtain the nutrient composition of the actual amount eaten. After summing all FFQ items for a participant, an average daily nutrient intake is obtained. Individuals with more than 10 missing lines of data will be excluded. The top and bottom 0.5% of the ratio of energy intake to estimated basal metabolic rate will be flagged as extreme outliers of nutrient intakes. All data will be exported from FETA data processing report into a readable Microsoft excel file for processing by the study statistician. The participant completes the FFQ between the pre-screening clinic and the beginning of the programme. The research dietitian then enters them into a FETA template for nutritional analysis. At a 6 month follow up, the research dietitian posts an FFQ to the participants. Participants return the FFQ by post using a stamped and labelled envelope provided. Diet Quality: Diet quality is assessed using the World Cancer Research Fund (WCRF)/American Institute of Cancer Research standardized scoring system 36 . Group education The LIAM Mc dietary group education programme follows the recommendations from the WCRF, the ESPEN Practical Guideline for Clinical Nutrition in Cancer 9 for cancer survivors and patients with advanced cancer, and the Healthy Ireland Food Pyramid 38 . The participants will engage with 5 dietetic education sessions that incorporate the 8 WCRF recommendations using the Healthy Ireland Food Pyramid highlighted in Supplementary Table 2. Sessions, designed using Canva (Canva Inc, Sydney, Australia) and PowerPoint (Microsoft Corporation, Washington, US) by a registered dietitian, include introduction, interaction, and reflection components. Focusing on behaviour change and group discussion, the programme aims to equip men with tools to make informed, evidence-based nutrition choices that enhance wellbeing. For example, the first session addresses managing expectations and establishing a dietary baseline using the Healthy Ireland Food Pyramid (Supplementary Figure 1). After a “Your Food Pyramid” exercise, participants compare their current diet to the Healthy Ireland Food Pyramid 38 . Each session explains the science behind recommendations, for example, session 2 highlights nutrient differences between wholegrain and refined grains (Supplementary Figure 2). Practical advice and tips to encourage positive dietary changes, such as increasing fruit and vegetable intake, are provided (Supplementary Figure 3), along with handouts for reference. Participants can also avail of opportunistic support during the physiotherapy sessions or whilst the registered dietitian is supervising the clinic. If relevant, the participant will be booked into a 1:1 personalised nutritional counselling appointment via a telehealth platform with the dietitian. Group discussions and a Q&A at the end of each session allow participants to clarify and reflect on the information. At the final session, participants receive an exit pack including Breakthrough Cancer Research’s Healthy Eating for Cancer Survivors and the Truth Behind Food and Cancer Prevention books to support ongoing nutrition guidance 39 , 40 . Patient and Public Involvement The LIAM Mc Trial involves a dedicated patient and public involvement (PPI) panel, including cancer patient advocates, who have contributed since the study’s inception. The team and PPI panel meet bi-monthly to discuss trial design, logistics, and participant support. A wider steering committee - comprising clinical experts, multidisciplinary members, community groups, and funders - meets quarterly to review trial progress, dissemination, and related projects. Adverse events A comprehensive overview of adverse event definitions, procedures, monitoring and reporting protocols has been detailed in the main LIAM Mc trial protocol 26 . No adverse events are expected from completing patient-reported outcomes, and participants may skip any questions they are uncomfortable answering. If any unexpected harm arises during participation, it will be recorded in the electronic data system and reported to the sponsor and Ethics Committee. Anonymized participant nutrition and clinical data will be included in the final results, which are expected to be available by early 2026. All dissemination activities will adhere to ethical guidelines and data protection regulations. Study details are already publicly accessible via ClinicalTrials.gov (NCT05946993). Discussion The LIAM Mc Trial is Ireland’s first dietitian-led group education programme for males with advanced or metastatic cancer. This 12-week multidisciplinary intervention combines group sessions with individual counselling to promote self-care in a supportive environment. It aims to fill gaps in current nutritional guidelines for cancer survivors by providing evidence-based, personalised nutrition advice tailored to the complex needs of this cohort, who often fall between “cancer survivor” and “palliative” categories 9 . Existing guidelines, such as ESPEN’s 9 , lack specificity for these patients, while the American Cancer Society 4 highlights the impact of ADT on body composition and deconditioning, underscoring the need for dietetic intervention to prevent sarcopenic obesity and related poor outcomes 4 , 8 , 12 – 18 , 41 , 42 . Body composition changes - muscle loss and fat gain - are not captured by BMI or weight loss measures alone, posing challenges especially in overweight or obese patients 43 . Irish outpatient settings typically rely on weight and height, missing critical body composition data. Although ESMO guidelines recognize ADT’s long-term effects on muscle and bone, they focus mainly on lifestyle interventions for bone health 11 , while NCCN emphasizes the importance of achieving optimal body composition through professional advice 7 . In this study, rectus femoris ultrasound is used alongside bioelectrical impedance analysis (BIA) to assess muscle and fat mass. Ultrasound offers a non-invasive, portable, and cost-effective way to directly monitor skeletal muscle in outpatient settings, overcoming limitations of BIA and infrequent computed tomography (CT)/ magnetic resonance imaging (MRI) imaging 32 , 44 . This novel approach supports dietitians in tracking nutritional intervention outcomes in survivorship care. Group education enhances male engagement and addresses the shortage of specialist oncology dietitians. Despite elevated chronic disease risk post-ADT, fewer than one-third of men with prostate cancer make lifestyle changes after diagnosis 23 . Barriers to dietary change include lack of guidance, perceptions of irrelevance post-treatment, food preferences, and access 45 . Conversely, group-based programmes with healthcare professional input have been shown to improve knowledge, offer psychosocial benefits, and support sustainable behaviour change 45 . Successful lifestyle programmes consider treatment side effects, time pressures, health perception, and age, using clear information, integrative approaches, and peer support 22 , 46 . While effective in diabetes and cardiac rehab cohorts dietetic 19 – 21 , group education for men with advanced cancer remains rare in Ireland. Given their longer survival and chronic disease risk, tailored dietetic interventions are essential. Group education allows dietitians to efficiently support multiple patients and may reduce costs associated with malnutrition, which exceeds €1.4 billion in Ireland and accounts for 15% of UK healthcare spending 47 , 48 . Conclusion Dietitian-led group education offers a cost-effective, scalable model to meet the nutritional needs of men living with and beyond advanced cancer. The LIAM Mc programme fosters behaviour change and acknowledges food’s broader role in wellbeing, empowering participants to make informed dietary choices. This feasibility study will inform future trials and support development of evidence-based dietetic care models for survivorship, potentially extending to other cancers and chronic conditions. Trial registration The trial was registered in ClinicalTrials.gov on May 10 th, 2023 (NCT05946993) https://clinicaltrials.gov/study/NCT05946993 Institutional review board statement The study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of Cork University Teaching Hospitals (ECM 4 [V] 01/11/2022). Informed consent statement Written informed consent was obtained from all subjects involved in the study. Data availability statement No data are associated with this article. Extended data Open Science Framework. Protocol For A Dietitian-Led Group Education Programme For Irish Males With Metastatic Genitourinary Cancer: The Men’s Health Initiative LIAM Mc Trial. https://doi.org/10.17605/OSF.IO/ZBCSM 29 . This project contains the following extended data: Supplementary Figure 1. (Session 1 Reflective Exercise “Your Food Pyramid”) Supplementary Figure 2. (Session 2 Nutritional Profile of Refined and Wholegrain Carbohydrates) Supplementary Figure 3. (Session 2 Practical Tips for Increasing Fruit and Vegetables into the Diet) Supplementary Table 1. (SPIRIT Checklist) Supplementary Table 2. (LIAM Mc Dietetic Group Education Schedule) Data is available under the terms of the CC-BY Attribution 4.0 International License. Acknowledgments We would like to thank the participants of this study, without whom there would be no research. A particular thanks to the Cardiac Renal Centre team at Cork University Hospital who welcomed us into their centre for our pilot, and to the staff at the Mardyke Arena who continue to facilitate and support this research. Thanks to our PPI Panel, who have ensured that the patient voice remains at the centre of this research. We are extremely grateful to the community supports who provide a wonderful service to this intervention and its participants: Dr Daniel Nuzum (Pastoral Care), Ms Aisling Deasy (Occupational Therapy), Mr Livingstone Kiwanuka (Social Work), Dr Fhami Ismail and Ms Theresa Walsh (Psycho-Oncology), Ms Sinead Power (Daffodil Centre), Ms Katrina Falvey (Cork Cancer Support, ARC) and Mr Tim Burke (Cork Sports Partnership). And lastly, thanks to the LIAM Mc research and intervention team: Ms Jane Prendergast (Physiotherapy), Ms Anne Marie Cusack (Research Nursing), Ms Joanne Kelly (Data) and Ms Denise Stenson-Russell (Research Nursing). 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Reference Source Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 15 Jan 2026 ADD YOUR COMMENT Comment Author details Author details 1 Cancer Research @UCC, College of Medicine and Health, University College Cork, Cork, County Cork, Ireland 2 Clinical Nutrition and Oncology Research Group, School of Food and Nutritional Sciences, University College Cork, Cork, County Cork, Ireland 3 Department of Clinical Nutrition and Dietetics, South Infirmary Victoria University Hospital, Cork, County Cork, Ireland 4 Department of Physiotherapy, Cork University Hospital, Cork, County Cork, Ireland 5 Department of Urology, Cork University Hospital, Cork, County Cork, Ireland 6 HRB Clinical Research Facility, School of Public Health, University College Cork, Cork, County Cork, Ireland 7 Catherine McAuley School of Nursing and Midwifery, University College Cork, Cork, County Cork, Ireland 8 CUH/UCC Cancer Centre, Cork University Hospital, Cork, County Cork, Ireland Katie E Johnston Roles: Investigation, Methodology, Project Administration, Resources, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Samantha J Cushen Roles: Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Fionnuala Muldoon Roles: Conceptualization, Writing – Review & Editing Laia Raigal-Aran Roles: Project Administration, Writing – Review & Editing Katarina Medved Roles: Project Administration, Writing – Review & Editing Stephanie Corkery Roles: Conceptualization, Writing – Review & Editing Anita Cahill Roles: Conceptualization, Writing – Review & Editing Christine Allan Roles: Project Administration, Software, Writing – Review & Editing Brendan Noonan Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing Jack P Gleeson Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing Competing interests Jack Gleeson receives funding support through a philanthropic donation from UPMC towards protected research time, during which this work was completed. Katie E Johnston was supported by the Irish Cancer Society’s Research Networking Award, which facilitated specialist training that was subsequently incorporated into this study as a Study Within A Trial (SWAT). The other co-authors have no conflicts of interest to declare. Grant information Health Research Board Ireland CTIC-2021-002 (UCC Cancer Trials Group). This work was also supported by Irish Cancer Society (MHI22BAM & SCRNA22JOH). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (1) version 1 Published: 15 Jan 2026, 9:10 https://doi.org/10.12688/hrbopenres.14267.1 Copyright © 2026 Johnston KE et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics VIEWS $counts.viewCount downloads Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Johnston KE, Cushen SJ, Muldoon F et al. Protocol for a Dietitian-Led Group Education Programme for Irish Males with Metastatic Genitourinary Cancer: The Men’s Health Initiative LIAM Mc Trial [version 1; peer review: 1 approved with reservations] . HRB Open Res 2026, 9 :10 ( https://doi.org/10.12688/hrbopenres.14267.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 15 Jan 2026 Views 0 Cite How to cite this report: Douglas P. Reviewer Report For: Protocol for a Dietitian-Led Group Education Programme for Irish Males with Metastatic Genitourinary Cancer: The Men’s Health Initiative LIAM Mc Trial [version 1; peer review: 1 approved with reservations] . HRB Open Res 2026, 9 :10 ( https://doi.org/10.21956/hrbopenres.15693.r53338 ) The direct URL for this report is: https://hrbopenresearch.org/articles/9-10/v1#referee-response-53338 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 18 Feb 2026 Pauline Douglas , Ulster University, Coleraine, Northern Ireland, UK Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15693.r53338 Paper is well written and provides a sound basis for a feasibility study protocol for dietetic led educational programme for Irish males living with metastatic genitourinary cancer in. Introduction Clear rationale provided for the feasibility study ... Continue reading READ ALL Paper is well written and provides a sound basis for a feasibility study protocol for dietetic led educational programme for Irish males living with metastatic genitourinary cancer in. Introduction Clear rationale provided for the feasibility study for this group of people living with cancer. The positive use of group education in supporting people with similar issues is well documented and advocated for. The inclusion of a dietetic protocol for this grouping is welcomed but also important to collect data to assess scalability which this project can do. There is a clear Aim and working hypothesis. Methodology The parameters and guidance recommendations followed are a sound basis for working with the nutritional factors for cancer survivors. The aspect of group education alongside provision for 1:1 personalised sessions is welcomed and ensures the participant voice is heard and appropriate queries answered. Sample size may be a little ambitious, but the protocol clearly documents as to why this number has been chosen. The nature of measurements to be completed at baseline, endpoint and particularly 6-month post intervention is welcomed. Appreciate due to the nature of the illness this may not be possible for all, and care needed in arranging follow up. There is an appropriate range of measurements and techniques being carried out. To gain best results in many of the measurements consistency of approach is important. How many people will be carrying out the measurements and how is accuracy ensured? Group education Following WCRF and ESPEN guidelines is clearly an important part of the educational design. It may be worth considering at the beginning of the first session to ascertain what nutritional challenges and changes the participants have already encountered/made and why. The use of the Your Food Pyramid is important but suggest this is at the end of finding out more about the above element in gaining more comprehensive data. Also capturing what the food preferences or dietary changes are that the person may already have which will influence /affect the baseline motivation for change. Overall comments While quality of life is noted and the aim to treat is with intent to prolong life and QoL I feel this could be stronger in the protocol rather than always saying healthy eating etc. These factors noted may give the participants a better reason to participate in this feasibility study. This is a much-needed piece of evidence-based research inclusive of translation to practice and scalability. This is an important initiative that truly warrants further study. This is a strong and intensive nutritional exploration in this group. I only have a few comments. The parameters and guidance recommendations followed are a sound basis for working with the nutritional factors for cancer survivors. I am missing where it captures what the food preferences or dietary changes are that the person may already have which will influence /affect the baseline motivation for change. While quality of life is noted and the aim to treat is with intent to prolong life and QoL I feel this could be stronger in the protocol rather than always saying healthy eating etc. Even using eating for health may be preferable. These factors noted may give the participants a better reason to participate in this feasibility study. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: Nutrition education. Published papers related to but not exclusive to cancer survivorship. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Douglas P. Reviewer Report For: Protocol for a Dietitian-Led Group Education Programme for Irish Males with Metastatic Genitourinary Cancer: The Men’s Health Initiative LIAM Mc Trial [version 1; peer review: 1 approved with reservations] . HRB Open Res 2026, 9 :10 ( https://doi.org/10.21956/hrbopenres.15693.r53338 ) The direct URL for this report is: https://hrbopenresearch.org/articles/9-10/v1#referee-response-53338 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 15 Jan 2026 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 Version 1 15 Jan 26 read Pauline Douglas , Ulster University, Coleraine, UK Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2026 Douglas P. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 18 Feb 2026 | for Version 1 Pauline Douglas , Ulster University, Coleraine, Northern Ireland, UK 0 Views copyright © 2026 Douglas P. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Paper is well written and provides a sound basis for a feasibility study protocol for dietetic led educational programme for Irish males living with metastatic genitourinary cancer in. Introduction Clear rationale provided for the feasibility study for this group of people living with cancer. The positive use of group education in supporting people with similar issues is well documented and advocated for. The inclusion of a dietetic protocol for this grouping is welcomed but also important to collect data to assess scalability which this project can do. There is a clear Aim and working hypothesis. Methodology The parameters and guidance recommendations followed are a sound basis for working with the nutritional factors for cancer survivors. The aspect of group education alongside provision for 1:1 personalised sessions is welcomed and ensures the participant voice is heard and appropriate queries answered. Sample size may be a little ambitious, but the protocol clearly documents as to why this number has been chosen. The nature of measurements to be completed at baseline, endpoint and particularly 6-month post intervention is welcomed. Appreciate due to the nature of the illness this may not be possible for all, and care needed in arranging follow up. There is an appropriate range of measurements and techniques being carried out. To gain best results in many of the measurements consistency of approach is important. How many people will be carrying out the measurements and how is accuracy ensured? Group education Following WCRF and ESPEN guidelines is clearly an important part of the educational design. It may be worth considering at the beginning of the first session to ascertain what nutritional challenges and changes the participants have already encountered/made and why. The use of the Your Food Pyramid is important but suggest this is at the end of finding out more about the above element in gaining more comprehensive data. Also capturing what the food preferences or dietary changes are that the person may already have which will influence /affect the baseline motivation for change. Overall comments While quality of life is noted and the aim to treat is with intent to prolong life and QoL I feel this could be stronger in the protocol rather than always saying healthy eating etc. These factors noted may give the participants a better reason to participate in this feasibility study. This is a much-needed piece of evidence-based research inclusive of translation to practice and scalability. This is an important initiative that truly warrants further study. This is a strong and intensive nutritional exploration in this group. I only have a few comments. The parameters and guidance recommendations followed are a sound basis for working with the nutritional factors for cancer survivors. I am missing where it captures what the food preferences or dietary changes are that the person may already have which will influence /affect the baseline motivation for change. While quality of life is noted and the aim to treat is with intent to prolong life and QoL I feel this could be stronger in the protocol rather than always saying healthy eating etc. Even using eating for health may be preferable. These factors noted may give the participants a better reason to participate in this feasibility study. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests No competing interests were disclosed. Reviewer Expertise Nutrition education. Published papers related to but not exclusive to cancer survivorship. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Douglas P. Peer Review Report For: Protocol for a Dietitian-Led Group Education Programme for Irish Males with Metastatic Genitourinary Cancer: The Men’s Health Initiative LIAM Mc Trial [version 1; peer review: 1 approved with reservations] . HRB Open Res 2026, 9 :10 ( https://doi.org/10.21956/hrbopenres.15693.r53338) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/9-10/v1#referee-response-53338 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions Adjust parameters to alter display View on desktop for interactive features Includes Interactive Elements View on desktop for interactive features Competing Interests Policy Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. 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Register $(document).ready(function () { signIn.createSignInAsRow($("#sign-in-form-gfb-popup")); $(".target-field").each(function () { var uris = $(this).val().split("/"); if (uris.pop() === "login") { $(this).val(uris.toString().replace(",","/")); } }); }); (function(){function c(){var b=a.contentDocument||a.contentWindow.document;if(b){var d=b.createElement('script');d.innerHTML="window.__CF$cv$params={r:'9fdf9d7deb6d8e2e',t:'MTc3OTE1NzE1MA=='};var a=document.createElement('script');a.src='/cdn-cgi/challenge-platform/scripts/jsd/main.js';document.getElementsByTagName('head')[0].appendChild(a);";b.getElementsByTagName('head')[0].appendChild(d)}}if(document.body){var a=document.createElement('iframe');a.height=1;a.width=1;a.style.position='absolute';a.style.top=0;a.style.left=0;a.style.border='none';a.style.visibility='hidden';document.body.appendChild(a);if('loading'!==document.readyState)c();else if(window.addEventListener)document.addEventListener('DOMContentLoaded',c);else{var e=document.onreadystatechange||function(){};document.onreadystatechange=function(b){e(b);'loading'!==document.readyState&&(document.onreadystatechange=e,c())}}}})();