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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

NCT ID NCT07809074

NEW Sponsor: The Hong Kong Polytechnic University Source: ClinicalTrials.gov ↗

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Cancelled before anyone took part.

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Approved
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First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer (CRC) STOMA

How to take part

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  1. The official record

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