Trauma-Focused Managing Cancer And Living Meaningfully (CALM-TF) for Newly Diagnosed and Recurrent Ovarian Cancer

Starting soon · Phase 3

Conditions studied: Ovarian Cancer (OvCa), Recurrent Ovarian Cancer

In brief

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

Key facts

Study ID

NCT07286162

Run by

University Health Network, Toronto

People needed

300

Starts

2026-03-01

Expected to finish

2031-12-31

Last updated by the study team

2026-01-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Princess Margaret Cancer Centre — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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