Feasibility of CALM in Patients With Ovarian Cancer
NCT06459271 · NA · Toronto, Ontario, Canada
- Condition
- Ovarian Cancer
- Disease stage
- Stage I-IV
- Phase
- NA
- Study type
- OTHER
- Intervention
- Managing Cancer And Living Meaningfully (CALM)
- Age
- 18 Years to
- Gender
- Female
- Sponsor
- University Health Network, Toronto
- Research institution
- University Health Network, Toronto
- Facility
- Princess Margaret Cancer Centre
- Research center
- Princess Margaret Cancer Centre
Summary
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.
Detailed description
While CALM has demonstrated effectiveness in reducing depression, death anxiety and increasing preparation for end of life among patients with advanced cancer later in the illness trajectory, its feasibility and effectiveness in addressing traumatic stress symptoms (TSS) soon after a diagnosis of advanced cancer has not previously been established. Findings of this study could inform the potential development of a larger randomized effectiveness trial. This study will involve a multi-method, single-arm, feasibility trial, approaching a total of 100 OC patients (50 newly diagnosed and 50 recently recurred) at Princess Margaret Cancer Centre (PM). Measurements will be administered at baseline, 3 months and 6 months. Participants who declined to participate in the intervention will be invited to share their reasons for opting out, contributing valuable insights to our records. A subset of purposefully sampled participants will also complete qualitative interviews following the completion of outcome measures at 6 months.
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.
Primary outcomes
Stanford Acute Stress Reaction Questionnaire (SASRQ); Clinical Evaluation Questionnaire (CEQ)-CALM
Secondary outcomes
Modified Experiences in Close Relationships (ECR-M-16); Condensed Memorial Symptom Assessment Scale (CMSAS); Patient Health Questionnaire (PHQ-9)