Feasibility of CALM in Patients With Ovarian Cancer

December 8, 2025 updated by: University Health Network, Toronto

A Feasibility Trial of Managing Cancer and Living Meaningfully (CALM) in Patients With Newly Diagnosed and Recurrent Advanced Ovarian Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Newly Diagnosed + Recently Recurred
n = 50 patients with ovarian cancer (stage III or IV) will be enrolled in the study (25 newly diagnosed and 25 recently recurred).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stanford Acute Stress Reaction Questionnaire (SASRQ)
Time Frame: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months)
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
Time Frame: This questionnaire will be administered at 3 months and 6 months only.
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

Outcome Measure
Measure Description
Time Frame
Modified Experiences in Close Relationships (ECR-M-16)
Time Frame: This questionnaire will be administered at baseline.
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)
Time Frame: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).
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)
Time Frame: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).
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)
Time Frame: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Gary M Rodin, MD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2024

Primary Completion (Estimated)

June 10, 2026

Study Completion (Estimated)

August 10, 2026

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-5885

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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