Trauma-Focused Managing Cancer And Living Meaningfully (CALM-TF) for Newly Diagnosed and Recurrent Ovarian Cancer
Opening soon Phase 3 NCT07286162
Run by University Health Network, Toronto · for 18 and older · Women
What this study is about
The goal of this clinical trial is to investigate if CALM-TF (Trauma-Focused Managing Cancer and Living Meaningfully) is effective in treating traumatic stress symptoms in women with advanced ovarian cancer. It will also learn whether the efficacy differs at new diagnosis versus at recurrence. The main questions it aims to answer are: 1. What is the effectiveness of CALM-TF in reducing traumatic stress symptoms in patients with newly diagnosed or recurrent advanced ovarian cancer, as measured at 3 and 6 months? 2. What are the effects of CALM-TF on depression, quality of life, and patient-perceived benefit of the intervention compared to usual care alone? 3. What are patient perceptions of their care experiences as explored through qualitative interviews? Researchers will compare CALM-TF to usual standard of care (which includes regular conversations with medical teams and meetings with social workers) to see if CALM-TF works to treat traumatic stress. Participants will: * Receive 3-6 sessions of CALM-TF over 3-6 months (45-60 minutes each) via video call, telephone, or in-person based on preference, OR receive usual care only * Complete questionnaires at baseline, 3 months, and 6 months * Continue to receive their standard cancer care throughout the study * Some participants may be invited to participate in qualitative interviews at 6 months
Who can join (things the study team will check)
✅ You may be able to join if…
- Newly diagnosed stage III or IV ovarian cancer OR recurrent ovarian cancer within six months of diagnosis or recurrence
- Age 18 years or older
- Able to speak and read English
- Able to provide informed consent
🚫 You may not be able to join if…
- Significant cognitive impairment that would interfere with the ability to participate in psychotherapy or complete study questionnaires
- Active psychosis or severe psychiatric condition requiring immediate psychiatric intervention
- Receiving ongoing psychotherapy at the time of recruitment
Where this trial is running
- Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Who to contact
Gary Rodin, MD · 416-946-4504 · gary.rodin@uhn.ca
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07286162.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.