Feasibility of CALM in Patients With Ovarian Cancer
NCT Number: NCT06459271
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patient Satisfaction|Ovarian Cancer
Interventions: OTHER: Managing Cancer And Living Meaningfully (CALM)
Sponsor: University Health Network, Toronto
Collaborators: Canadian Institutes of Health Research (CIHR)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-10
Completion Date: 2025-08-10
Locations: Princess Margaret Cancer Centre, Toronto, Ontario, M5G 2M9, Canada

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 are the prevalence and correlates of traumatic stress symptoms at baseline in patients with newly diagnosed or recently recurred advanced OC

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.

Primary Outcome Measures: Stanford Acute Stress Reaction Questionnaire (SASRQ), 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., This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months)|Clinical Evaluation Questionnaire (CEQ)-CALM, The CEQ is a 7-item validated questionnaire, created by our research team to assess the perceived benefit of interactions with health care providers in domains relevant to advanced cancer., This questionnaire will be administered at 3 months and 6 months only.
Secondary Outcome Measures: Modified Experiences in Close Relationships (ECR-M-16), The ECR-M-16 is a validated measure with 16-items, has been thoughtfully adapted to be less time-consuming and alleviate any potential burden for patients who may be physically unwell., This questionnaire will be administered at baseline.|Condensed Memorial Symptom Assessment Scale (CMSAS), The CMSAS CMSAS stands as a straightforward and validated self-report evaluation tool, comprising 14 items. It effectively gauges various aspects such as energy level, dry mouth, appetite, weight loss, pain, nausea, drowsiness etc. These facets are organized into three subscales: physical, psychological and symptom distress., This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).|Patient Health Questionnaire (PHQ-9), The PHQ-9 is a diagnostic tool used in primary care settings to establish criteria-based diagnoses for depression. PHQ-9 is a 9-tem, self-reported questionnaire which consists of the 9 depression criteria which is highlighted within the DSM-IV. PHQ-9 is particularly favoured due to its concise structure, which efficiently identifies the presence of depressive disorders and is also able to rate the severity of depressive symptoms., This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).|Death and Dying Distress Scale (DADDS), The DADDS is a tool used to evaluate the distress caused by a patients thoughts on death and dying over the previous two weeks. DADDS is a 15-items questionnaire with the aims of alleviating the fear of death and fostering psychological development (Nissim et al., 2011; Shapiro et al., 2021).The validity of DADDS has been rigorously established, with factor analysis demonstrating distress related to two factors: Finitude and Dying., This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).