Trauma-Focused Managing Cancer And Living Meaningfully (CALM-TF) for Newly Diagnosed and Recurrent Ovarian Cancer
Key facts
- Where
- Toronto, KanadaSee the site
- Phase
- 3. fázis
Where in Kanada
- Princess Margaret Cancer CentreToronto, KanadaNo 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?
Trial details
- Who runs it
- University Health Network, Toronto
- Trial code
- NCT07286162
- Record updated
- 2026. január 27.
- 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.