Trauma-Focused Managing Cancer And Living Meaningfully (CALM-TF) for Newly Diagnosed and Recurrent Ovarian Cancer

NCT07286162 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: OZUHN-045
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate if CALM-TF (Trauma-Focused Managing Cancer and Living Meaningfully) is effective in treating traumatic stress symptoms in women with advanced ovarian cancer. It will also learn whether the efficacy differs at new diagnosis versus at recurrence. The main questions it aims to answer are:

• Receive 3-6 sessions of CALM-TF over 3-6 months (45-60 minutes each) via video call, telephone, or in-person based on preference, OR receive usual care only
• Complete questionnaires at baseline, 3 months, and 6 months
• Continue to receive their standard cancer care throughout the study
• Some participants may be invited to participate in qualitative interviews at 6 months

Conditions

Ovarian Cancer (OvCa); Recurrent Ovarian Cancer

Keywords

randomized controlled trial; ovarian cancer; recurrence; newly diagnosed; CALM; Managing Cancer And Living Meaningfully; Psychotherapy; psychosocial support

Outcome Measures

Primary Outcomes (1)

• Stanford Acute Stress Reaction Questionnaire-II (SASRQ-II)

  Traumatic stress symptoms are measured by the Stanford Acute Stress Reaction Questionnaire-II (SASRQ-II), a validated 30-item self-report instrument specifically designed to assess traumatic stress symptoms based on DSM-5 criteria. The SASRQ-II provides a total score range of 0-150, where higher scores reflect increasing symptom severity and cut-off scores of \>40 indicate clinically significant traumatic stress symptoms.

  From enrolment to the end of study at 6 months

Secondary Outcomes (7)

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

  Baseline only

• Condensed Memorial Symptom Assessment Scale (CMSAS)

  From enrolment to the end of the study at 6 months

• Patient Health Questionnaire (PHQ-9)

  From enrolment to the end of the study at 6 months

• Death and Dying Distress Scale (DADDS)

  From enrolment to the end of the study at 6 months

• EuroQol 5-Dimension 5-Level Health Questionnaire (EQ-5D-5L Health Questionnaire)

  From enrolment to the end of the study at 6 months

Study Arms (2)

CALM-TF plus Usual Care

EXPERIMENTAL

Participants receive Trauma-Focused Managing Cancer and Living Meaningfully (CALM-TF), a brief manualized psychotherapeutic intervention consisting of 3-6 individual sessions over 3-6 months (45-60 minutes each). Sessions delivered via secure video conferencing (Microsoft Teams), telephone, or in-person based on participant preference. Participants also continue to receive usual standard of care throughout the intervention period.

Behavioral: Trauma-Focused Managing Cancer and Living Meaningfully

Usual Care Alone

NO INTERVENTION

Participants receive usual standard of care only, which includes frequent conversations with their medical team regarding their care and meetings with social workers regarding financial or other practical issues. Participants have access to formal or specialized psychotherapeutic interventions upon referral by their primary physician or member of their circle of care.

Interventions

Trauma-Focused Managing Cancer and Living Meaningfully BEHAVIORAL

CALM-TF is a brief, manualized psychotherapeutic intervention that incorporates trauma-focused elements into the established CALM framework. It includes a present-oriented focus with particular attention to affect regulation, relational support, and attachment security, specifically designed to address traumatic stress symptoms triggered by a diagnosis or recurrence. The intervention consists of 3-6 sessions delivered over 3-6 months, with each session lasting 45-60 minutes. Sessions are delivered by trained therapists through multiple modalities including secure web-conferencing software (Microsoft Teams), telephone, or in-person visits based on patient preference. CALM-TF focuses on four broad and interconnected content domains: (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 mortal

Also known as: CALM-TF

CALM-TF plus Usual Care

Eligibility Criteria

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

You may qualify if:

• Newly diagnosed stage III or IV ovarian cancer OR recurrent ovarian cancer within six months of diagnosis or recurrence
• Age 18 years or older
• Able to speak and read English
• Able to provide informed consent

You may not qualify if:

• Significant cognitive impairment that would interfere with the ability to participate in psychotherapy or complete study questionnaires
• Active psychosis or severe psychiatric condition requiring immediate psychiatric intervention
• Receiving ongoing psychotherapy at the time of recruitment

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Ovarian Cancer Canada: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephanie Lheureux, MD, PhD

  Princess Margaret Cancer Centre, University Health Network

  PRINCIPAL INVESTIGATOR

• Gary Rodin, MD

  Princess Margaret Cancer Centre, University Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary Rodin, MD

CONTACT

416-946-4504; gary.rodin@uhn.ca

Anne Rydall, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts will also be blinded to participant treatment group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants randomized to the intervention arm of the trial will receive: Usual care, plus Trauma focused Managing Cancer and Living Meaningfully (referred to as CALM-TF), a psychotherapeutic intervention that aims to alleviate traumatic stress symptoms in patients with advanced cancer. Participants randomized to the control arm of the trial will receive: Usual care alone, which may include referral for psychosocial/psychiatric support should the patient request it, or should their clinician deem such support necessary. The trial team will not interfere with usual care referrals, but such referrals will be documented in the trial records.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

CA (1)