Effect of Traditional Chinese Medicine Combined Group Psychotherapy on Psychological Distress Management and Gut Micro-biome Regulation for Colorectal Cancer Survivors: A Single-arm Phase I Clinical Trial

Objective: To evaluate the efficacy and feasibility of utilizing Traditional Chinese Medicine(TCM) combined group psychotherapy intervention on psychological distress management and gut micro-biome regulation for colorectal(CRC) survivors. Methods: : A single-arm phase I clinical trial was conducted between December 2020 and December 2021 in Xiyuan and Beijing Cancer Hospital in China. Inclusion criteria was stage I-III CRC survivors after radical surgery with age between 18-75. The intervention was a six-week online TCM combined group psychotherapy intervention including 90 minutes’ communication, TCM lifestyle coaching, self-acupressure guidance and mindfulness practice led by TCM oncologist and psychiatrist each week. Outcomes were measured by Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), Fear of Cancer Recurrence Inventor (FCRI), and Quality of Life Questionnaire(QLQ-C30). Fetal samples before and after intervention were collected for 16Sr RNA analysis. Results: : We recruited 40 CRC survivors and 38 of them finally completed all interventions with average age of 58±13 years’ old. Paired t-test showed that SAS at week 2(35.4±5.8), week 4(37.9±10.5) and week 6(31.3±6.4) during the intervention was significantly lower than baseline (42.1±8.3, p<0.05 respectively). SDS score also declined substantially from baseline (38.8±10.7) to week 2(28.3±8.8, p<0.001) and week 6(25.4±7.7, p<0.001). FCRI decreased from 19.4±7.2 at baseline to 17.5±7.1 at week 4(p=0.038) and 16.3±5.8 at week 6(p=0.008). Although changes of QLQ-C30 were not statistically prominent, insomnia and fatigue significantly alleviated. The abundances of gut microbiota Intestinibacter , Terrisporobacter , Coprobacter and Gordonibacter were all significantly elevated after intervention. Conclusions: : TCM combined group psychotherapy intervention is feasible and effective to reduce CRC survivors’ psychological distress and modulate certain gut bacteria which might be associated with brain-gut axis effect. It is necessary to carry out with phase II randomized controlled clinical trial.