Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer

NCT06543537 · Dana-Farber Cancer Institute

Recruiting

In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study

This two-arm, parallel group-randomized research study is to test a new communication tool (CASI) for people with ovarian cancer, caregivers, and clinicians. This is a pilot feasibility study, which means this is the first time researchers are studying CASI. Clinicians will be randomized into one of the two study groups, Arm 1 or Arm 2, and patients and caregivers will be enrolled in the study arm to which their clinician has been randomized. The research study procedures include screening for eligibility, audio recorded clinic visits, and questionnaires. Participation in this research study is expected to last for up to 12 weeks for patients and caregivers, and for up to 52 weeks for clinicians. It is expected that up to 112 people will take part in this research study, including up to 50 patients, 50 caregivers, and 12 clinicians (six dyads). The National Institute for Nursing Research is supporting this research by providing funding.

Eligibility criteria

Participant Inclusion Criteria: * At least 18 years old * Able to speak, understand, and respond to questions written in English * Willing to be audio recorded * Have a diagnosis of advanced ovarian cancer (defined as stage III, stage IV, or recurrent disease) * Be under the care of a participating clinician dyad * Be scheduled for chemotherapy during the recruitment period * Be signed up or willing to sign up for Patient Gateway Caregiver Inclusion Criteria: * At least 18 years old * Able to speak, understand, and respond to questions written in English * Willing to be audio recorded * Be a family member, partner, or friend of a patient participant with whom the patient participant discusses their cancer care Clinician Inclusion Criteria: * Be employed at DFCI as an oncologist, nurse practitioner, or physician assistant * Take care of at least 4 patients per month with advanced ovarian cancer (defined as stage III, stage IV, or recurrent disease) in the outpatient setting Participant Exclusion Criteria: * Age of \<18 years * Unable to consent

Study design

Enrollment target: 112 participants

Allocation: randomized

Masking: none

Age groups: adult, older_adult

Timeline

Starts: 2025-01-17

Estimated completion: 2026-12-31

Last updated: 2025-11-04

Interventions

Behavioral: Collaborative Agenda-Setting Intervention

Primary outcomes

• Enrollment Rate (Pre-consent)

Sponsor

Dana-Farber Cancer Institute · other

With: National Institute of Nursing Research (NINR)

Contacts & investigators

ContactRachel Pozzar, PhD · contact · Rachel_Pozzar@DFCI.HARVARD.EDU · 857-215-0743

InvestigatorRachel Pozzar, PhD · principal_investigator, Dana-Farber Cancer Institute

All locations (1)

Dana-Farber Cancer InstituteRecruiting

Boston, Massachusetts, United States

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