Online program to help cancer patients manage psychological distress
The Online Adaptation of Managing Cancer and Living Meaningfully (iCALM): A Phase II Randomized Controlled Trial
This study is testing an online program to help people with advanced cancer manage their stress and improve their well-being compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04757155 on ClinicalTrials.gov |
What this trial studies
This study evaluates an online adaptation of a psychosocial intervention called Managing Cancer and Living Meaningfully (iCALM) for patients with advanced cancer. The aim is to assess the acceptability, feasibility, and preliminary efficacy of iCALM in reducing psychological distress and improving well-being. Participants will be randomized to receive either iCALM or usual care, with assessments conducted at multiple time points to measure satisfaction, depression, anxiety, and quality of life. The study will involve 50 patients from the Princess Margaret Cancer Centre.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic cancer who can access the internet and are able to participate in online sessions.
Not a fit: Patients currently receiving structured psychotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide accessible mental health support to improve the quality of life for patients with advanced cancer.
How similar studies have performed: Previous studies have shown that the original CALM intervention effectively reduces depression in cancer patients, suggesting potential success for this online adaptation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 years of age; * ability to read and write in English; * able to access the internet. * not cognitively impaired; * able to commit to the required online sessions; and * patients at Princess Margaret Cancer Centre with a confirmed or working diagnosis of advanced or metastatic cancer with an expected survival of 12-18 months \[stage III or IV lung cancer, any stage of pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary or peri-ampullary cancer or other stage IV (metastatic) GI cancer; stage III or IV ovarian and fallopian tube cancers, or other stage IV gynecological (GYNE) cancer; and stage IV breast, genitourinary (GU), sarcoma, melanoma or endocrine cancers\]. Exclusion Criteria: * Inability to pass the cognitive screening test (Short Orientation-Memory-Concentration Test (SOMC) score \<20, Katzman et al., 1983); and * actively receiving a structured or semi-structured psychotherapy at Princess Margaret Cancer Centre
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Gary Rodin, MD — University Health Network, Toronto
- Study coordinator: Gary Rodin, MD
- Email: Gary.Rodin@uhn.ca
- Phone: 4169644504
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.