Testing a new communication tool for ovarian cancer patients and their caregivers
Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer
NA · Dana-Farber Cancer Institute · NCT06543537
This study is testing a new communication tool to see if it helps ovarian cancer patients, their caregivers, and doctors work better together in planning care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Dana-Farber Cancer Institute (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06543537 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the Collaborative Agenda-Setting Intervention (CASI), a new communication tool designed for patients with advanced ovarian cancer, their caregivers, and clinicians. The study involves a two-arm, parallel group randomized design where clinicians are assigned to one of two groups, and patients and caregivers are enrolled based on their clinician's group. Participants will undergo screening for eligibility, audio recorded clinic visits, and complete questionnaires over a period of up to 12 weeks for patients and caregivers, and up to 52 weeks for clinicians. The goal is to assess the feasibility and effectiveness of CASI in enhancing communication and care planning.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of advanced ovarian cancer who are scheduled for chemotherapy.
Not a fit: Patients with early-stage ovarian cancer or those not receiving chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve communication and care coordination for patients with ovarian cancer, leading to better treatment experiences and outcomes.
How similar studies have performed: While this is a pilot study and the CASI approach is novel, similar communication interventions have shown promise in enhancing patient-clinician interactions in other cancer types.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Rachel Pozzar, PhD — Dana-Farber Cancer Institute
- Study coordinator: Rachel Pozzar, PhD
- Email: Rachel_Pozzar@DFCI.HARVARD.EDU
- Phone: 857-215-0743
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma