Recruiting

CASI

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06543537

Conditions

Ovarian Cancer

Ovarian Neoplasms

Ovarian Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Collaborative Agenda-Setting Intervention

Study Details

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)

Conditions

Ovarian Cancer

Ovarian Neoplasms

Ovarian Carcinoma

Study ID

NCT06543537

Start date

Jan 17, 2025

Status verified date

Jun, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

112 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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

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

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.

Primary outcome measure

  • Enrollment Rate [ Time Frame: Pre-consent ]

Central Contacts and Locations

Central contacts

Rachel Pozzar, PhD

857-215-0743Rachel_Pozzar@DFCI.HARVARD.EDU

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Rachel Pozzar, PhD

857-215-0743Rachel_Pozzar@dfci.harvard.edu

Principal Investigator:

Rachel Pozzar, PhD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • Ovarian Cancer
  • Ovarian Neoplasms
  • Ovarian Carcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-06-17.