Colorectal Cancer (CRC)MSC-OPNCT07809074
Mindfulness and Self-Compassion Intervention for Ostomy Patients Due to Colorectal Cancer on Loneliness (MSC-OP)
A study testing The MSC-OP group in people with Colorectal Cancer (CRC) and Stoma, run by The Hong Kong Polytechnic University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (CRC), Stoma
- What is being tested?
- The MSC-OP group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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
- Being tested
- The MSC-OP group, usual care
- Keywords
- mindfulness, self-compassion, pilot RCT, loneliness, self-stigma, social anxiety, colorectal cancer, stoma, ostomy, feasibility
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The MSC-OP groupBehavioural
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 careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The usual care control group | Other | CRC ostomates will receive social support, encompassing follow-ups by stoma nurses and social workers. Receives: Behavioral: usual care |
| The MSC-OP group | Experimental | CRC ostomates will receive MSC-OP in the intervention group delivered by a trained therapist. Receives: Behavioral: The MSC-OP group; Behavioral: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach
The total number of individuals who respond to the posters via phone or QR code.
Measured: Throughout the recruitment period, approximately 4 months
Eligibility rate
The proportion of responders who meet the inclusion criteria.
Measured: Throughout the recruitment period, approximately 4 months
Consent rate
The proportion of eligible participants who provide signed informed consent;
Measured: Throughout the recruitment period, approximately 4 months
Recruitment rate
The average number of participants enrolled per month
Measured: Throughout the recruitment period, approximately 4 months
Adherence
Quantified by the total attendance times at the scheduled 6 sessions of the intervention
Measured: From the start to the end of treatment at 6 weeks
Completion rate
The proportion of total patients who complete the post-intervention evaluations
Measured: 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.
Measured: From the start to the end of treatment at 6 weeks
Secondary outcomes (4)
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.
Measured: From enrollment to the end of treatment at 6 weeks
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.
Measured: From enrollment to the end of treatment at 6 weeks
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.
Measured: From enrollment to the end of treatment at 6 weeks
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.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809074
- Sponsor's protocol ID
- HSEARS20260609006
- Acronym
- MSC-OP
- Status last verified
- Aug 2026
- First submitted
- 2 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be made available in order to protect participant privacy and to comply with local institutional review board (IRB) and data governance policies.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07809074
- Acronym / sponsor ID
- MSC-OP / HSEARS20260609006
- Conditions
- Colorectal Cancer (CRC), Stoma
- Keywords
- mindfulness, self-compassion, pilot RCT, loneliness, self-stigma, social anxiety, colorectal cancer, stoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The usual care control group | Other | Behavioral: usual careCRC ostomates will receive social support, encompassing follow-ups by stoma nurses and social workers. |
| The MSC-OP group | Experimental | Behavioral: The MSC-OP group, Behavioral: usual careCRC ostomates will receive MSC-OP in the intervention group delivered by a trained therapist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The MSC-OP groupCRC 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 | Behavioural | The MSC-OP group |
| usual careCRC 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. | Behavioural | The MSC-OP group, The usual care control group |
Primary outcome
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.
Eligibility rate
Time frame: Throughout the recruitment period, approximately 4 months
The proportion of responders who meet the inclusion criteria.
Consent rate
Time frame: Throughout the recruitment period, approximately 4 months
The proportion of eligible participants who provide signed informed consent;
Recruitment rate
Time frame: Throughout the recruitment period, approximately 4 months
The average number of participants enrolled per month
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
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
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.
4 secondary outcomes
Loneliness
Time frame: From enrollment to the end of treatment at 6 weeks
Self-compassion
Time frame: From enrollment to the end of treatment at 6 weeks
Self-stigma
Time frame: From enrollment to the end of treatment at 6 weeks
Social anxiety
Time frame: From enrollment to the end of treatment at 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. IPD will not be made available in order to protect participant privacy and to comply with local institutional review board (IRB) and data governance policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing The MSC-OP group in people with Colorectal Cancer (CRC) and Stoma, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minjie Li (852-62143127, minjie.li@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: Throughout the recruitment period, approximately 4 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.