Feasibility of CALM in Patients With Ovarian Cancer

NCT06459271 | Recruiting DMC

• 1 other identifier: 23-5885
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 1.Is it feasible and acceptable to implement CALM for patients with newly diagnosed or recently recurred advanced OC
2. 2.What are the prevalence and correlates of traumatic stress symptoms at baseline in patients with newly diagnosed or recently recurred advanced OC

Conditions

Patient Satisfaction; Ovarian Cancer

Keywords

ovarian cancer; psychological care; CALM; psychotherapeutic intervention; psychological distress

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Modified Experiences in Close Relationships (ECR-M-16)

  This questionnaire will be administered at baseline.

• Condensed Memorial Symptom Assessment Scale (CMSAS)

  This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).

• Patient Health Questionnaire (PHQ-9)

  This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).

• Death and Dying Distress Scale (DADDS)

  This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).

Study Arms (1)

Newly Diagnosed + Recently Recurred

EXPERIMENTAL

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)

Interventions

Managing Cancer And Living Meaningfully (CALM) OTHER

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.

Newly Diagnosed + Recently Recurred

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Gary M Rodin, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan A George, BSc

CONTACT

6475463114; megan.george@uhn.ca

Anne Rydall, MSc

CONTACT

416-910-7349; anne.rydall@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants (patients with newly diagnosed and recently recurred ovarian cancer) will receive the intervention.

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 14, 2024
• Study Start: June 10, 2024
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): August 10, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)