Clinical trial NCT06459271: Feasibility of CALM in Patients With Ovarian Cancer
Official title: A Feasibility Trial of Managing Cancer and Living Meaningfully (CALM) in Patients With Newly Diagnosed and Recurrent Advanced Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patient Satisfaction
Ovarian Cancer
Keywords: ovarian cancer
psychological care
CALM
psychotherapeutic intervention
psychological distress
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2024-06-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants (patients with newly diagnosed and recently recurred ovarian cancer) will receive the intervention.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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:
measure: Stanford Acute Stress Reaction Questionnaire (SASRQ)
timeFrame: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months)
measure: Clinical Evaluation Questionnaire (CEQ)-CALM
timeFrame: This questionnaire will be administered at 3 months and 6 months only.
Secondary outcomes:
measure: Modified Experiences in Close Relationships (ECR-M-16)
timeFrame: This questionnaire will be administered at baseline.
measure: Condensed Memorial Symptom Assessment Scale (CMSAS)
timeFrame: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).
measure: Death and Dying Distress Scale (DADDS)
timeFrame: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Gary M Rodin, MD
role: PRINCIPAL_INVESTIGATOR
References: