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
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
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
Parallel
Trauma-Focused Managing Cancer and Living Meaningfully
BehavioralCALM-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
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.
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.
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.
Patient Health Questionnaire (PHQ-9)
Depression severity is measured by the Patient Health Questionnaire (PHQ-9), a validated 9-item instrument assessing depression severity that has demonstrated reliability and validity in cancer populations. Scores may range from 0-27, with higher scores reflecting increasing severity of depressive symptoms. A cut-off score of 10 is used to reflect moderate depressive symptoms.
Death and Dying Distress Scale (DADDS)
Distress related to thoughts on death and dying are measured by the Death and Dying Distress Scale (DADDS), a validated 15-item questionnaire evaluating distress caused by a patient's thoughts on death and dying. Factor analysis demonstrates distress related to two factors: Finitude and Dying. Total scores may range from 0-75, with higher scores indicating greater death-related distress.
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University Health Network, Toronto
Lead sponsor
Ovarian Cancer Canada
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
