Recruiting

CALM

Sponsor:

University Health Network, Toronto

Code:

NCT06459271

Conditions

Patient Satisfaction

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Managing Cancer And Living Meaningfully (CALM)

Study Details

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 is the patient experience of CALM-TF at new diagnosis or recurrence

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

Patient Satisfaction

Ovarian Cancer

Study ID

NCT06459271

Start date

Jun 10, 2024

Status verified date

Aug, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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).

Interventions

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.

Primary outcome measure

  • Stanford Acute Stress Reaction Questionnaire (SASRQ) [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Megan A George, BSc

6475463114megan.george@uhn.ca

Anne Rydall, MSc

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

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Gary M Rodin, MD FRCPC

gary.rodin@uhn.ca

Anne Rydall, MSc

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

More Information

Sponsor

University Health Network, Toronto

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-08-24.