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Feasibility of CALM in Patients With Ovarian Cancer

NCT06459271 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-16

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Managing Cancer And Living Meaningfully (CALM)

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Gary M Rodin, MD · University Health Network, Toronto

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-10
Primary Completion
2026-06-10
Completion
2026-08-10

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06459271 on ClinicalTrials.gov