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NCT Number: NCT07809074

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

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.

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Key information

Conditions

Colorectal Cancer (CRC) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Stoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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.

Primary outcomes

  1. Reach

    Time frame: Throughout the recruitment period, approximately 4 months

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

  2. Eligibility rate

    Time frame: Throughout the recruitment period, approximately 4 months

    The proportion of responders who meet the inclusion criteria.

  3. Consent rate

    Time frame: Throughout the recruitment period, approximately 4 months

    The proportion of eligible participants who provide signed informed consent;

  4. Recruitment rate

    Time frame: Throughout the recruitment period, approximately 4 months

    The average number of participants enrolled per month

  5. Adherence

    Time frame: From the start to the end of treatment at 6 weeks

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

  6. Completion rate

    Time frame: From the start to the end of treatment at 6 weeks

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

  7. Retention

    Time frame: From the start to the end of treatment at 6 weeks

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

Secondary outcomes

  1. Loneliness

    Time frame: From enrollment to the end of treatment at 6 weeks

    The 6-item Chinese version of the UCLA Loneliness Scale (ULS-6). Items (e.g., "How often do you feel that you lack companionship?") are rated from 1 ("Never") to 4 ("Often") with a total score from 6 to 24. Higher total scores reflect greater levels of perceived loneliness.

  2. Self-compassion

    Time frame: From enrollment to the end of treatment at 6 weeks

    the 12-item Neff Self-compassion Scale (SCS). Items are rated on a 5-point Likert scale ranging from 1("Almost never") to 5 ("Almost always") with a total score ranges from 12 to 60. A higher score reflects greater levels of self-compassion.

  3. Self-stigma

    Time frame: From enrollment to the end of treatment at 6 weeks

    the 9-item Self-Stigma Scale-Short (SSS-S) Respondents rate their agreement on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree) with a total score from 9 to 36. Higher score reflecting higher level of self-stigma.

  4. Social anxiety

    Time frame: From enrollment to the end of treatment at 6 weeks

    The Social Phobia Scale (SPS) Responses are recorded on a 5-point Likert-type scale from 0 ("Not at all characteristic or true of me") to 4 ("Extremely characteristic or true of me") with a total score ranging from 0 to 80. A higher score reflects higher social anxiety.

Study contacts

Contact information is provided by the study sponsor or research team.

Man Huen Ng

CONTACT

[email protected]

852-55442858

Minjie Li

CONTACT

[email protected]

852-62143127

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

The Feasibility of Mindfulness and Self-Compassion Intervention for Loneliness, Stigma and Social Anxiety Among Colorectal Cancer Patients With Ostomy: A Randomized Controlled Pilot Trial

Acronym: MSC-OP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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