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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

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Abstract

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 Hospital and Beijing Cancer Hospital in China. Inclusion criteria included stage I–III CRC survivors after radical surgery with age between 18 and 75. The intervention was a 6-week online TCM combined group psychotherapy intervention including 90-min 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). Fecal 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, symptom burden of 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.

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Data Availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

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Acknowledgements

We appreciate all patients and their caregivers for participating our study by sharing their own experiences and feelings with us. It was very touching moment when people were willing to tear their wounds again to support other peers. We also thank physicians and research assistants in Xiyuan Hospital and Beijing Cancer Hospital for their help on patients’ recruitment and management.

Funding

This study is funded by Scientific and Technological Innovation Project of China Academy of Chinese Medical Sciences, grant number: C12021A01819 (principal investigator: Lingyun Sun MD); Colorectal Cancer Project of Clinical Cooperation of TCM and Western Medicine for Major Difficult Diseases of Family Administration of Traditional Chinese Medicine (grant number: 070030003); National Natural Science Foundation of China, Youth Program(grant number: 82004191).

Author information

Authors and Affiliations

  1. Oncology Department, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China

    Lingyun Sun & Yufei Yang

  2. Rehabilitation Department, Beijing Cancer Hospital, Beijing, China

    Ying Pang & Lili Tang

  3. Clinical Basic Research Center, China Academy of Chinese Medical Sciences, Beijing, China

    Zixu Wang

  4. Graduate School, Beijing University of Chinese Medicine, Beijing, China

    Jiaxi Liu, Rongyan Peng & Yunzi Yan

Authors
  1. Lingyun Sun
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  2. Ying Pang
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  3. Zixu Wang
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  4. Jiaxi Liu
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  5. Rongyan Peng
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  6. Yunzi Yan
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  7. Yufei Yang
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  8. Lili Tang
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Lingyun Sun, Ying Pang, Jiaxiliu and Rongyan Peng. The first draft of the manuscript was written by Lingyun Sun and Ying Pang, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Lili Tang.

Ethics declarations

Ethics approval

The Ethic Board of Xiyuan Hospital approve the study protocol(2020XLA048-2).

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All patients consented to participate.

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All authors consented to publish the current manuscript.

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The authors declare no competing interests.

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Sun, L., Pang, Y., Wang, Z. et al. 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. Support Care Cancer 31, 698 (2023). https://doi.org/10.1007/s00520-023-08131-5

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