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

Phase 3Not Yet RecruitingNCT07286162

University Health Network, Toronto300 enrolled

Overview

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

This study examines whether a brief psychotherapy called Trauma-Focused Managing Cancer and Living Meaningfully (CALM-TF) can help women with advanced ovarian cancer who are experiencing traumatic stress symptoms. Traumatic stress refers to the psychological impact of traumatic events, which in cancer care includes the diagnosis, progression, or recurrence of advanced disease. Research shows that up to 45% of patients with ovarian cancer experience clinically significant traumatic stress symptoms that meet diagnostic criteria for acute stress disorder. CALM-TF is a manualized psychotherapeutic intervention that builds on an established therapy called CALM (Managing Cancer and Living Meaningfully), which has previously been shown to reduce depression and improve communication with healthcare providers in patients with advanced cancer. CALM-TF incorporates trauma-focused components specifically designed to address traumatic stress symptoms that arise at the time of diagnosis or recurrence of ovarian cancer. The intervention consists of 3-6 individual therapy sessions delivered over 3-6 months, with each session lasting 45-60 minutes. Sessions can be conducted via secure video conferencing, telephone, or in-person based on participant preference. The therapy focuses on four interconnected content areas: symptom management and communication with healthcare providers; changes in self and relationships with close others; sense of meaning and purpose in life; and hopes and fears about the future and mortality, with trauma-focused components integrated throughout. This is a multi-site randomized controlled trial enrolling 300 women with newly diagnosed stage III or IV ovarian cancer or recurrent ovarian cancer (within six months of diagnosis or recurrence). Participants are randomly assigned in a 1:1 ratio to receive either CALM-TF plus usual care or usual care alone. Usual care includes regular conversations with medical teams and meetings with social workers regarding financial or practical issues, with access to specialized psychological support through referral. The study uses validated questionnaires to measure traumatic stress symptoms, depression, quality of life, death anxiety, and perceived benefit of care at three time points: baseline, 3 months, and 6 months after enrolment. The primary outcome is traumatic stress symptoms at 6 months measured by the Stanford Acute Stress Reaction Questionnaire-II (SASRQ-II), a 30-item instrument with scores ranging from 0-150, where scores above 40 indicate clinically significant symptoms. A subset of up to 30 participants will be invited to participate in qualitative interviews after completing their 6-month assessment to share their experiences with the intervention or usual care, explore factors that influenced their traumatic stress experience, and discuss how the therapy was integrated into their daily lives. The study also includes a health economic evaluation to assess the cost-effectiveness of CALM-TF compared to usual care over the 6-month period. The findings of this RCT will inform healthcare policy and clinical practice guidelines for comprehensive psychosocial care, with potential for CALM-TF to be integrated into standard care.

Interventions

Trauma-Focused Managing Cancer and Living MeaningfullyBEHAVIORAL

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

Outcomes

Primary Outcomes

Stanford Acute Stress Reaction Questionnaire-II (SASRQ-II)

Traumatic stress symptoms are measured by the Stanford Acute Stress Reaction Questionnaire-II (SASRQ-II), a validated 30-item self-report instrument specifically designed to assess traumatic stress symptoms based on DSM-5 criteria. The SASRQ-II provides a total score range of 0-150, where higher scores reflect increasing symptom severity and cut-off scores of \>40 indicate clinically significant traumatic stress symptoms.

Time frame: From enrolment to the end of study at 6 months

Secondary Outcomes

Experiences in Close Relationships-Modified-16 (ECR-M-16)

Attachment security is measured by the ECR-M-16, a validated 16-item measure adapted to measure close relationships in patients with advanced cancer. Two 8-item subscales are derived from this measure, reflecting levels of anxious attachment and avoidant attachment, which can be helpful to understand and address attachment issues in patients with advanced cancer. Items are rated from 1 (agree) to 7 (disagree), with higher scores reflecting greater attachment insecurity.

Time frame: Baseline only

Condensed Memorial Symptom Assessment Scale (CMSAS)

Physical symptoms commonly experienced by cancer patients are measured by the Condensed Memorial Symptom Assessment Scale (CMSAS), a validated 14-item instrument that assesses distress related to symptoms including pain, fatigue, nausea, and drowsiness. Serves as an important covariate to control for physical symptom burden that may influence psychological outcomes. Symptoms are rated as present or not, with the level of distress associated with physical symptoms rated from 0 (not at all) to 4 (very much), and the frequency of psychological symptoms (worry, feeling sad, feeling nervous) rated 1 (rarely) to 4 (almost constantly). Higher scores reflect increasing symptom burden.