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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Hong Kong Polytechnic University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: The usual care control groupOther 1 intervention
Group B: The MSC-OP groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Reach

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

Time frame
Throughout the recruitment period, approximately 4 months
2

Eligibility rate

The proportion of responders who meet the inclusion criteria.

Time frame
Throughout the recruitment period, approximately 4 months
3

Consent rate

The proportion of eligible participants who provide signed informed consent;

Time frame
Throughout the recruitment period, approximately 4 months
4

Recruitment rate

The average number of participants enrolled per month

Time frame
Throughout the recruitment period, approximately 4 months

Secondary outcomes

1

Loneliness

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.

Time frame
From enrollment to the end of treatment at 6 weeks
2

Self-compassion

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.

Time frame
From enrollment to the end of treatment at 6 weeks
3

Self-stigma

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.

Time frame
From enrollment to the end of treatment at 6 weeks
4

Social anxiety

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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