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

November 3, 2025 updated by: Rachel Pozzar, Dana-Farber Cancer Institute

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
        • Principal Investigator:
          • Rachel Pozzar, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: CASI Intervention

Enrolled patients and caregivers will complete:

  • Audio recorded baseline visit
  • CASI via mobile device, laptop, or desktop computer 1 week prior to CASI visit 1
  • Audio recorded CASI visit 1
  • CASI via mobile device, laptop, or desktop computer 1 week prior to CASI visit 2
  • Audio recorded CASI visit 2
  • CASI via mobile device, laptop, or desktop computer 1 week prior to CASI visit 3
  • Audio recorded CASI visit 3
  • End of study visit

For each enrolled patient, enrolled clinicians will complete:

  • Audio recorded baseline visit
  • Audio recorded CASI visit 1
  • Audio recorded CASI visit 2
  • Audio recorded CASI visit 3

Enrolled clinicians will also complete:

  • Baseline visit, one time
  • End of study visit, one time
Behavioral: Collaborative Agenda-Setting Intervention
A collaborative agenda-setting intervention (CASI) to promote patient-centered communication, set agendas for discussion at in-clinic visits, increase discussion of psychosocial concerns, and reduce clinician burden. The intervention is integrated into the patient portal and electronic health record. Prior to a clinic visit, the intervention elicits patients' and caregivers' preferences and concerns, then communicates this information to clinicians. Patients, caregivers, and clinicians receive communication resources, while patients and caregivers receive tailored educational materials and navigation to supportive care services.
Other Names:
  • CASI
No Intervention: Arm 2: Control

Enrolled patients and caregivers will complete:

  • Audio recorded baseline visit
  • Audio recorded visit 1 will proceed according to usual, oncology care
  • Audio recorded visit 2 will proceed according to usual, oncology care
  • Audio recorded visit 3 will proceed according to usual, oncology care
  • End of study visit

For each enrolled patient, enrolled clinicians will complete:

  • Audio recorded baseline visit
  • Audio recorded visit 1 will proceed according to usual, oncology care
  • Audio recorded visit 2 will proceed according to usual, oncology care
  • Audio recorded visit 3 will proceed according to usual, oncology care

Enrolled clinicians will also complete:

  • Baseline visit, one time
  • End of study visit, one time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment Rate
Time Frame: Pre-consent
The proportion of approached participants that are enrolled. Feasibility of an efficacy trial is defined as ≥60% enrollment among approached participants.
Pre-consent

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of Intervention
Time Frame: Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment
Feasibility of an efficacy trial is defined as a mean Acceptability of Intervention Measure score of ≥4.0 among participants in the intervention group. The Acceptability of Intervention Measure is a four-item questionnaire rated on a 5 point Likert-type scale from 5 "Strongly Agree" to "1 Strongly Disagree" with a total scores range of 4 to 20. A higher score represents greater intervention acceptability.
Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment
Proportion of Participant-Rated Intervention Helpfulness
Time Frame: Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment
Feasibility of an efficacy trial is defined as ≥60% of participants in the intervention group agreeing with the survey item "the CASI was helpful to me."
Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment
Proportion of Participant-Rated Intervention Burden
Time Frame: Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment
Feasibility of an efficacy trial is defined as ≤20% of participants in the intervention group agreeing with the survey item "the CASI placed a considerable burden on me."
Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment
Change in the Functional Assessment of Cancer Therapy - General (FACT-G) Score from Baseline to 12 Weeks (Arm 1)
Time Frame: Baseline and 12 weeks after enrollment
Defined as the numeric proportion of participants that experience a clinically meaningful improvement in health-related quality of life from baseline to follow-up. A clinically meaningful improvement is defined as an increase of ≥4 points in the Functional Assessment of Cancer Therapy - General (FACT-G) total score. The FACT-G is a 27-item questionnaire rated on a 5 point Likert-type scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. A higher score represents greater participant well-being.
Baseline and 12 weeks after enrollment
Change in FACT-G Score from Baseline to 12 Weeks (Arm 2)
Time Frame: Baseline and 12 weeks after enrollment
Defined as the numeric proportion of patient participants that experience a clinically meaningful improvement in health-related quality of life from baseline to follow-up. A clinically meaningful improvement is defined as an increase of ≥4 points in the FACT-G total score.
Baseline and 12 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Rachel Pozzar, PhD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 5, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Estimated)

November 4, 2025

Last Update Submitted That Met QC Criteria

November 3, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-358
  • K23NR020219 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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