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)
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)
Age of <18 years
Unable to consent
Parallel
Collaborative Agenda-Setting Intervention
BehavioralA 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.
Enrollment Rate
The proportion of approached participants that are enrolled. Feasibility of an efficacy trial is defined as ≥60% enrollment among approached participants.
Acceptability of Intervention
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.
Proportion of Participant-Rated Intervention Helpfulness
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."
Proportion of Participant-Rated Intervention Burden
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."
Change in the Functional Assessment of Cancer Therapy - General (FACT-G) Score from Baseline to 12 Weeks (Arm 1)
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.
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Dana-Farber Cancer Institute
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
