Feasibility of CALM in Patients With Ovarian Cancer

Trial Title: Feasibility of CALM in Patients With Ovarian Cancer

NCT ID: NCT06459271

Condition: Patient Satisfaction
Ovarian Cancer

Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial

Conditions: Keywords:
ovarian cancer
psychological care
CALM
psychotherapeutic intervention
psychological distress

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: All participants (patients with newly diagnosed and recently recurred ovarian cancer) will receive the intervention.

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Managing Cancer And Living Meaningfully (CALM)
Description: Our team has developed a brief, manualized, individual and couple-based psychotherapeutic intervention for patients living with advanced cancer and their primary caregivers called Managing Cancer and Living Meaningfully (CALM). CALM is a brief supportive-expressive therapy consisting of 3-6 sessions of 30-60 minutes delivered over the course of 3-6 months. This tailored therapy is focused on the most common challenges and concerns facing individuals living with advanced cancer. These four broad content domains are: 1) symptom management and communication with healthcare providers; 2) changes in self and in relationships with close others; 3) sense of meaning and purpose in life; and 4) hopes and fears about the future and mortality. The aim is to offer patients and caregivers reflective space and a supportive environment to reflect on and process the various practical and profound aspects of their life while facing advanced illness.
Arm group label: Newly Diagnosed + Recently Recurred

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.

Criteria for 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.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Princess Margaret Cancer Centre

Address:
City: Toronto
Zip: M5G 2M9
Country: Canada

Status: Recruiting

Contact:
Last name: Gary M Rodin, MD FRCPC
Email: gary.rodin@uhn.ca

Contact backup:
Last name: Anne Rydall, MSc

Phone: 416-910-7349
Email: anne.rydall@uhn.ca

Start date: June 10, 2024

Completion date: August 10, 2025

Lead sponsor:
Agency: University Health Network, Toronto
Agency class: Other

Collaborator:
Agency: Canadian Institutes of Health Research (CIHR)
Agency class: Other

Source: University Health Network, Toronto

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06459271