Mindfulness and Self-Compassion Intervention for Ostomy Patients Due to Colorectal Cancer on Loneliness (MSC-OP)

NCT07809074 | Not Yet Recruiting

• 1 other identifier: HSEARS20260609006
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Loneliness is a profound health risk for colorectal cancer (CRC) survivors, particularly those with stomas who face significant stigma and social anxiety. According to the hypervigilance model, individuals with loneliness often internalize negative stereotypes and anticipate social rejection, leading to chronic isolation and perceived social isolation. Mindful Self Compassion (MSC) offers a potential solution by targeting the psychological mechanisms of shame and self-criticism. By activating the emotional "soothing system" and fostering a sense of common humanity, self-compassion can buffer the impact of stigma and reduce social fear. Despite its promise, the application of MSC within the oncology-ostomy context has rarely been tested. This randomized controlled pilot trial aims to evaluate the feasibility and preliminary efficacy of an adapted MSC for ostomy patients (MSC-OP) program due to CRC in alleviating loneliness, stigma, and social anxiety through improving self-compassion among CRC patients with ostomy. The findings will determine the suitability of Mindful Self-compassion as a targeted intervention to improve the psychosocial outcomes and social reintegration of this vulnerable population.

Conditions

Colorectal Cancer (CRC); Stoma

Keywords

mindfulness; self-compassion; pilot RCT; loneliness; self-stigma; social anxiety; colorectal cancer; stoma; ostomy; feasibility

Outcome Measures

Primary Outcomes (7)

• Reach

  The total number of individuals who respond to the posters via phone or QR code.

  Throughout the recruitment period, approximately 4 months

• Eligibility rate

  The proportion of responders who meet the inclusion criteria.

  Throughout the recruitment period, approximately 4 months

• Consent rate

  The proportion of eligible participants who provide signed informed consent;

  Throughout the recruitment period, approximately 4 months

• Recruitment rate

  The average number of participants enrolled per month

  Throughout the recruitment period, approximately 4 months

• Adherence

  Quantified by the total attendance times at the scheduled 6 sessions of the intervention

  From the start to the end of treatment at 6 weeks

• Completion rate

  The proportion of total patients who complete the post-intervention evaluations

  From the start to the end of treatment at 6 weeks

• Retention

  The proportion of participants who completed the MSC-OP intervention until the end of the study period.

  From the start to the end of treatment at 6 weeks

Secondary Outcomes (4)

• Loneliness

  From enrollment to the end of treatment at 6 weeks

• Self-compassion

  From enrollment to the end of treatment at 6 weeks

• Self-stigma

  From enrollment to the end of treatment at 6 weeks

• Social anxiety

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

The usual care control group

OTHER

CRC ostomates will receive social support, encompassing follow-ups by stoma nurses and social workers.

Behavioral: usual care

The MSC-OP group

EXPERIMENTAL

CRC ostomates will receive MSC-OP in the intervention group delivered by a trained therapist.

Behavioral: The MSC-OP group; Behavioral: usual care

Interventions

The MSC-OP group BEHAVIORAL

CRC ostomates will receive MSC-OP in the intervention group delivered by a trained therapist. We will adapt the SC-MSC (six weekly sessions with duration of 1.5 hours for each session) \[41\] for ostomy patients due to CRC. The SC-MSC is a shorted adaptation (9 hours) of the full MSC program created by Dr. Kristin Neff, and her colleague Dr. Christopher Germer. It was designed so that people could learn the key practices needed to transform their relationship with themselves \[41\]. The six sessions are as follows: What is self-compassion? Challenges to practicing self-compassion Discovering your compassionate voice Self-compassion and resilience Self-compassion and others Embracing your life beyond the stoma

The MSC-OP group

usual care BEHAVIORAL

CRC ostomates will receive social support, encompassing follow-ups by stoma nurses and social workers. This includes psychoeducation on stoma-related information, self-care, and the navigation of community resources or social-recreational activities. Stoma management support, psychosocial aid, and home-based follow-ups are provided as needed. Emergency stoma-related events are referred to hospital-based specialist nurses.

The MSC-OP group; The usual care control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years old;
• colon cancer or rectal cancer patients with stoma;
• the stoma won't be reversed within 3 months when conducting the baseline survey;
• after surgery of stoma formation;
• complete active treatment;
• Cantonese or Mandarin speaking.

You may not qualify if:

• Diagnosed with cognitive impairment or dementia (e.g., Alzheimer's disease) as determined using International Classification of Diseases (ICD-10) criteria;
• diagnosis of a severe mental disorder;
• could not provide informed consent.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Minjie Li

CONTACT

852-62143127; minjie.li@polyu.edu.hk

Man Huen Ng

CONTACT

852-55442858; ng55442858@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A research assistant, blinded to the group allocation, will collect data at baseline and right after the six-week MSC-OP at PolyU campus by questionnaires on loneliness, self-stigma, social anxiety and self-compassion.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share