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

Summary

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

Conditions

• Ovarian Cancer (OvCa)
• Recurrent Ovarian Cancer

Interventions

BEHAVIORAL

Trauma-Focused Managing Cancer and Living Meaningfully

CALM-TF is a brief, manualized psychotherapeutic intervention that incorporates trauma-focused elements into the established CALM framework. It includes a present-oriented focus with particular attention to affect regulation, relational support, and attachment security, specifically designed to address traumatic stress symptoms triggered by a diagnosis or recurrence. The intervention consists of 3-6 sessions delivered over 3-6 months, with each session lasting 45-60 minutes. Sessions are delivered by trained therapists through multiple modalities including secure web-conferencing software (Microsoft Teams), telephone, or in-person visits based on patient preference. CALM-TF focuses on four broad and interconnected content domains: (1) symptom management and communication with healthcare providers; (2) changes in self and in relationships with close others; (3) sense of meaning and purpose in life; and (4) hopes and fears about the future and mortal

Sponsors & Collaborators

• Ovarian Cancer Canada

  collaborator UNKNOWN

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Stephanie Lheureux, MD, PhD · Princess Margaret Cancer Centre, University Health Network

• Gary Rodin, MD · Princess Margaret Cancer Centre, University Health Network

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-01

Primary Completion

2031-03-01

Completion

2031-12-31

Countries

• Canada

Study Locations