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

NCT ID: NCT06543537

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-17
• Study Completion Date: 2026-12-31

Brief 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)

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.

Conditions

Ovarian Cancer; Ovarian Neoplasms; Ovarian Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Collaborative Agenda-Setting Intervention

Intervention Type: BEHAVIORAL

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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CASI

Eligibility Criteria

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

• 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

• 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

Exclusion Criteria

• Age of <18 years
• Unable to consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Rachel Pozzar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel Pozzar, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel Pozzar, PhD

Role: CONTACT

Rachel_Pozzar@DFCI.HARVARD.EDU

857-215-0743

Facility Contacts

Rachel Pozzar, PhD

Role: primary

Rachel_Pozzar@dfci.harvard.edu

857-215-0743

Other Identifiers

K23NR020219

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-358

Identifier Type: -

Identifier Source: org_study_id