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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Trauma-Focused Managing Cancer and Living Meaningfully

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Health Network, Toronto

Lead sponsor

Ovarian Cancer Canada

Collaborator