Colorectal Cancer (CRC), Stoma
Conditions
Keywords
mindfulness, self-compassion, pilot RCT, loneliness, self-stigma, social anxiety, colorectal cancer, stoma, ostomy, feasibility
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.
Interventions
BEHAVIORALThe MSC-OP group
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
BEHAVIORALusual care
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.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion rate | From the start to the end of treatment at 6 weeks | The proportion of total patients who complete the post-intervention evaluations |
| Retention | 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. |
| Reach | Throughout the recruitment period, approximately 4 months | The total number of individuals who respond to the posters via phone or QR code. |
| Eligibility rate | Throughout the recruitment period, approximately 4 months | The proportion of responders who meet the inclusion criteria. |
| Consent rate | Throughout the recruitment period, approximately 4 months | The proportion of eligible participants who provide signed informed consent; |
| Recruitment rate | Throughout the recruitment period, approximately 4 months | The average number of participants enrolled per month |
| Adherence | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Loneliness | 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. |
| Self-compassion | 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. |
| Self-stigma | 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. |
| Social anxiety | 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. |
Contacts
CONTACTMinjie Li
CONTACTMan Huen Ng
Outcome results
None listed