Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer
2 other identifiers
interventional
112
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable ovarian-cancer
Started Jan 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedStudy Start
First participant enrolled
January 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
November 4, 2025
November 1, 2025
1.4 years
August 5, 2024
November 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Enrollment Rate
The proportion of approached participants that are enrolled. Feasibility of an efficacy trial is defined as ≥60% enrollment among approached participants.
Pre-consent
Secondary Outcomes (5)
Acceptability of Intervention
Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment
Proportion of Participant-Rated Intervention Helpfulness
Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment
Proportion of Participant-Rated Intervention Burden
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)
Baseline and 12 weeks after enrollment
Change in FACT-G Score from Baseline to 12 Weeks (Arm 2)
Baseline and 12 weeks after enrollment
Study Arms (2)
Arm 1: CASI Intervention
EXPERIMENTALEnrolled 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
Arm 2: Control
NO INTERVENTIONEnrolled 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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Age of \<18 years
- Unable to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rachel Pozzar, PhD
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 5, 2024
First Posted
August 9, 2024
Study Start
January 17, 2025
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
November 4, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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.