Clinical trial · Interventional
Feasibility of CALM in Patients With Ovarian Cancer
A Feasibility Trial of Managing Cancer and Living Meaningfully (CALM) in Patients With Newly Diagnosed and Recurrent 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 feasibility trial is to determine the feasibility and acceptability of implementing a brief evidence-based psychotherapeutic intervention, Managing Cancer And Living Meaningfully (CALM), at the time of a new diagnosis and recurrence of ovarian cancer (OC). The main questions are: 1. Is it feasible and acceptable to implement CALM for patients with newly diagnosed or recently recurred advanced OC 2. What is the patient experience of CALM-TF at new diagnosis or recurrence Participants will be asked to complete questionnaires at baseline and at 3 and 6 months following a diagnosis or recurrence of stage III or IV OC. Participants will also be invited to participate in 3-6 sessions of CALM therapy.
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 | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Patient Satisfaction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Managing Cancer And Living Meaningfully (CALM) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Newly Diagnosed + Recently Recurred
- description
- n = 50 patients with ovarian cancer (stage III or IV) will be enrolled in the study (25 newly diagnosed and 25 recently recurred).
- interventionNames
- Other: Managing Cancer And Living Meaningfully (CALM)
Primary outcomes (2)
- measure
- Stanford Acute Stress Reaction Questionnaire (SASRQ)
- timeFrame
- This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months)
- description
- The SASRQ is a self-reported DSM-IV correspondent scale to measure a range of symptoms associated with Acute Stress Disorder (ASD), encompassing dissociation, trauma re-experiencing, avoidance behaviours, anxiety, hyperarousal, and functional impairment. The SASRQ consists of 30-items utilizing a 6-point scale that ranges from 0=not experienced to 4=very often experienced. Demonstrating robust psychometric properties, including strong test-retest reliability and consistent evidence of predictive, construct, discriminant, and convergent validity across varied populations, the SASRQ serves as a reliable and valid tool for assessment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * new diagnosis or recurrence of stage III or stage IV OC; * age ≥18 years * able to complete outcome measures and engage in CALM in English. Exclusion Criteria: * evidence of cognitive impairment indicated in the medical record, communicated by the OC clinic team, or determined by research staff at recruitment; * receiving psychological or psychiatric counseling from the Department of Supportive Care at PM at the time of recruitment.
References
Publications (0)
Data not yet available