Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer
- Conditions
- Interventions
- Registration Number
- NCT06543537
- Lead Sponsor
- Dana-Farber Cancer Institute
- 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 care...
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 112
- 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
- Age of <18 years
- Unable to consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: CASI Intervention Collaborative Agenda-Setting 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
- Primary Outcome Measures
Name Time Method Enrollment Rate Pre-consent The proportion of approached participants that are enrolled. Feasibility of an efficacy trial is defined as ≥60% enrollment among approached participants.
- Secondary Outcome Measures
Name Time Method Proportion of Participant-Rated Intervention Burden Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment 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."
Proportion of Participant-Rated Intervention Helpfulness Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment 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."
Change in FACT-G Score from Baseline to 12 Weeks (Arm 2) Baseline and 12 weeks after enrollment 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.
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 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 rate...
Acceptability of Intervention Approximately 12 (patient and caregiver participants) and 52 (clinician participants) weeks after enrollment 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 scor...
Trial Locations
- Locations (2)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States