Clinical trial · Interventional
Trauma-Focused Managing Cancer And Living Meaningfully (CALM-TF) for Newly Diagnosed and Recurrent Ovarian Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer (OvCa) | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.85 |
| Recurrent Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trauma-Focused Managing Cancer and Living Meaningfully | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CALM-TF plus Usual Care
- description
- Participants receive Trauma-Focused Managing Cancer and Living Meaningfully (CALM-TF), a brief manualized psychotherapeutic intervention consisting of 3-6 individual sessions over 3-6 months (45-60 minutes each). Sessions delivered via secure video conferencing (Microsoft Teams), telephone, or in-person based on participant preference. Participants also continue to receive usual standard of care throughout the intervention period.
- interventionNames
- Behavioral: Trauma-Focused Managing Cancer and Living Meaningfully
- type
- NO_INTERVENTION
- label
- Usual Care Alone
- description
- Participants receive usual standard of care only, which includes frequent conversations with their medical team regarding their care and meetings with social workers regarding financial or other practical issues. Participants have access to formal or specialized psychotherapeutic interventions upon referral by their primary physician or member of their circle of care.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available