Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer
NCT Number: NCT06543537
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ovarian Cancer|Ovarian Neoplasms|Ovarian Carcinoma
Interventions: BEHAVIORAL: Collaborative Agenda-Setting Intervention
Sponsor: Dana-Farber Cancer Institute
Collaborators: National Institute of Nursing Research (NINR)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 112
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-10-01
Completion Date: 2025-12-31
Locations: Brigham and Women's Hospital, Boston, Massachusetts, 02215, United States|Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States

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)

Primary Outcome Measures: 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 Outcome Measures: 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., Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment|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.", Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment|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.", 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), 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), 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