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

Last updated: January 28, 2025
Sponsor: Dana-Farber Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Ovarian Cancer

Vaginal Cancer

Treatment

Collaborative Agenda-Setting Intervention

Clinical Study ID

NCT06543537
24-358
K23NR020219
  • Ages > 18
  • Female

Study Summary

This research is being done to test a new communication tool for people with ovarian cancer, caregivers, and clinicians.

The name of the intervention in this research study is:

-Collaborative Agenda-Setting Intervention (CASI)

Eligibility Criteria

Inclusion

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, orrecurrent 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 thepatient 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 asstage III, stage IV, or recurrent disease) in the outpatient setting

Exclusion

Participant Exclusion Criteria:

  • Age of <18 years

  • Unable to consent

Study Design

Total Participants: 112
Treatment Group(s): 1
Primary Treatment: Collaborative Agenda-Setting Intervention
Phase:
Study Start date:
January 17, 2025
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

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