Abstract
Objective
This study examined whether a 4-week group-based mindfulness intervention would be superior in reducing psychological distress in colorectal cancer (CRC) patients compared to a psychoeducation and cognitive behavioural skills learning support active control group.
Methods
Patients with CRC were randomized via Computerised Permuted Block Randomisation to mindfulness or active control groups (2-h weekly sessions over 4 weeks). Outcomes were measured pre-intervention, and 8 weeks and 6 months post-baseline. The primary outcome was psychological distress measured by the Hospital Anxiety and Depression Scale. Secondary outcomes were generic quality of life (QoL), disease specific QoL, mindfulness, and intervention credibility and acceptability.
Results
Sixty-eight participants were randomized to mindfulness (n=35) or active control group (n=33). Uptake of potentially eligible patients consenting was low (28.0%) and the dropout rate was 33.8%. Depression scores were reduced in both groups at week 8 (P=0.020). Control participants had greater improvement in generic mental QoL scores at week 8 than mindfulness (P=0.023). In disease specific QoL, there was reduction in impotence symptom in the mindfulness group (P=0.022) and reduction in faecal incontinence in the control group (P=0.019). The embarrassment symptom had a significantly lower increase in the mindfulness group at week 8 compared to the control group (P=0.009). Both groups rated the treatments as credible and acceptable.
Conclusions
Mindfulness was not superior to the active control group in terms of alleviating psychological distress but both treatments were associated with some improvements in depression. There was low uptake of both interventions. (Trial registration number: ACTRN12616001033437)
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Acknowledgements
We would like to thank Prof. Mark Williams and Prof. Willem Kuyken of the Oxford Mindfulness Centre for permission to use some of their handout materials for the purpose of this study. We would also like to thank guest speakers for the active control group: Rachel Holdaway and Chelsea Halliwell from Beat Bowel Cancer NZ; Dr. Dean Harris (Oncologist), Clarice Hebblethwaite (Dietician) and Denise Stevenson (bowel nurse). Michelle Falloon (Clinical Research Nurse) assisted with recruitment and data collection in both arms of the trial.
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Andrew McCombie was responsible for the design of the study and ran the statistical analyses and randomization process. Jennifer Jordan, Roger Mulder, Kishion Dee, and Ee Lin Ong helped design the interventions and the study. Ee Lin Ong and Fernanda Zimmerman instructed the mindfulness group and Kishion Dee instructed the active control group. Chris Frampton assisted with statistical analyses. Frank Frizelle provided input to the design and the oncological and surgical aspects of the study. All authors have contributed and critically reviewed the manuscript and approved the final version. All authors have read and agreed to the published version of the manuscript.
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This project has received funding from the Departments of Surgery and Psychological Medicine at the University of Otago, Christchurch as well as the Southern Cross Healthcare Society. The only commercial funder was Southern Cross Healthcare Society and they were not involved in study design, collection, analysis, or interpretation of data.
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The authors declare that there is no conflict of interests regarding the publication of this paper.
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McCombie, A., Jordan, J., Mulder, R. et al. A Randomized Controlled Trial of Mindfulness in Recovery from Colorectal Cancer. Chin. J. Integr. Med. 29, 590–599 (2023). https://doi.org/10.1007/s11655-023-3632-1
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DOI: https://doi.org/10.1007/s11655-023-3632-1