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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
The MSC-OP group
BehavioralCRC 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
BehavioralCRC 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
Trial outcomes
Primary outcomes
Reach
The total number of individuals who respond to the posters via phone or QR code.
Eligibility rate
The proportion of responders who meet the inclusion criteria.
Consent rate
The proportion of eligible participants who provide signed informed consent;
Recruitment rate
The average number of participants enrolled per month
Secondary outcomes
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.
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.
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.
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.
Locations
Sponsors and contacts
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