Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ovarian Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Enrollment Rate
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
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.
Investigators
Rachel Pozzar
Principal Investigator
Dana-Farber Cancer Institute
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
- •Caregiver Inclusion Criteria:
- •At least 18 years old
- •Able to speak, understand, and respond to questions written in English
Exclusion Criteria
- •Age of \<18 years
- •Unable to consent
Outcomes
Primary Outcomes
Enrollment Rate
Time Frame: Pre-consent
The proportion of approached participants that are enrolled. Feasibility of an efficacy trial is defined as ≥60% enrollment among approached participants.
Secondary Outcomes
- Proportion of Participant-Rated Intervention Burden(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)
- Change in FACT-G Score from Baseline to 12 Weeks (Arm 2)(Baseline and 12 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)
- Acceptability of Intervention(Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment)