Evaluating a psychological intervention for ovarian cancer patients
A Feasibility Trial of Managing Cancer and Living Meaningfully (CALM) in Patients With Newly Diagnosed and Recurrent Advanced Ovarian Cancer
This study is testing a new therapy called CALM to see if it helps people who have just been diagnosed or have had a recurrence of advanced ovarian cancer feel better and cope with their situation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06459271 on ClinicalTrials.gov |
What this trial studies
This feasibility trial aims to assess the implementation and acceptability of the Managing Cancer And Living Meaningfully (CALM) intervention for patients newly diagnosed or recently recurred with advanced ovarian cancer. Participants will complete questionnaires at baseline, 3 months, and 6 months, and may engage in 3-6 sessions of CALM therapy. The study will also explore the prevalence of traumatic stress symptoms in these patients and gather insights from those who opt out of the intervention. The findings could pave the way for a larger randomized effectiveness trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a new diagnosis or recurrence of stage III or IV ovarian cancer.
Not a fit: Patients with cognitive impairments or those currently receiving psychological counseling may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve psychological well-being and reduce traumatic stress symptoms in ovarian cancer patients.
How similar studies have performed: While CALM has shown effectiveness in later stages of cancer care, its application shortly after diagnosis in ovarian cancer is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * new diagnosis or recurrence of stage III or stage IV OC; * age ≥18 years * able to complete outcome measures and engage in CALM in English. Exclusion Criteria: * evidence of cognitive impairment indicated in the medical record, communicated by the OC clinic team, or determined by research staff at recruitment; * receiving psychological or psychiatric counseling from the Department of Supportive Care at PM at the time of recruitment.
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Gary M Rodin, MD — University Health Network, Toronto
- Study coordinator: Megan A George, BSc
- Email: megan.george@uhn.ca
- Phone: 6475463114
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.