NCT06459271 Feasibility of CALM in Patients With Ovarian Cancer
| NCT ID | NCT06459271 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Patient Satisfaction |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-06-10 |
| Primary Completion | 2026-06-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-06-10 with a primary completion date of 2026-06-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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.
Contact & Investigator
Gary M Rodin, MD
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT06459271 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Patient Satisfaction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06459271 currently recruiting?
Yes, NCT06459271 is actively recruiting participants. Contact the research team at megan.george@uhn.ca for enrollment information.
Where is the NCT06459271 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06459271 clinical trial?
NCT06459271 is sponsored by University Health Network, Toronto. The principal investigator is Gary M Rodin, MD at University Health Network, Toronto. The trial plans to enroll 50 participants.