Tests a trauma-focused talk program for women with advanced ovarian cancer
Tests a program easing traumatic stress in women with new or returned ovarian cancer.
Plain-language title generated from the registry record
Registry title: Trauma-Focused Managing Cancer And Living Meaningfully (CALM-TF) for Newly Diagnosed and Recurrent Ovarian Cancer
Key facts
- Where
- Toronto, CanadaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with advanced ovarian cancer, newly diagnosed or recurrent, to test a talking therapy for traumatic stress.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Newly diagnosed stage III or IV ovarian cancer, or recurrent ovarian cancer within six months of diagnosis or recurrence
- Earlier treatment
- People already in ongoing psychotherapy cannot join
Main reasons for not taking part
- Significant cognitive impairment that would get in the way of therapy or questionnaires
- Active psychosis or severe psychiatric condition needing immediate psychiatric care
- Ongoing psychotherapy at the time of recruitment
Read by machine on 9 November 2026.
Where in Canada
- Princess Margaret Cancer CentreToronto, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Health Network, Toronto
- Trial code
- NCT07286162
- Record updated
- 27 January 2026
- Original description
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.Read full original descriptionShow less
Trauma-Focused Managing Cancer And Living Meaningfully (CALM-TF): A Phase III Randomized Controlled Trial of an Intervention Targeting Traumatic Stress in Patients With Advanced Ovarian Cancer
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
Inclusion: 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.
Exclusion: Receiving ongoing psychotherapy at the time of recruitment; 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.