Four Conversations RCT
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Four Conversations
- Registration Number
- NCT02944344
- Lead Sponsor
- Duke University
- Brief Summary
The purpose of this study is to see whether patients with metastatic breast cancer, their caregivers, and their healthcare providers can improve in shared decision making (SDM) and preparedness around end of life (EOL) planning through participation in Reimagine's online Four Conversations™ program. The goal is to close clinical practice gaps and enhance the quality of care for patients with metastatic breast cancer through increased competence and performance of healthcare providers and healthcare systems.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 357
- Diagnosed with metastatic breast cancer (MBC), caregiver to patient with MBC who is enrolled in this study, or MBC provider
- Age ≥ 18 years
- Internet access through a computer, laptop, tablet, or other mobile device
- Able/willing to have an online interaction with a Reimagine Pillar Guide
- Providing informed consent
- Able to read/write English
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Four Conversations Intervention Four Conversations Subjects in this arm will participate in Reimagine's online Four Conversations program during the initial study period of four weeks. Waitlisted Control Four Conversations Subjects in this arm will continue to receive standard care from their healthcare providers during the initial study period (i.e. no intervention). After four weeks, subjects will then participate in Reimagine's online Four Conversations program.
- Primary Outcome Measures
Name Time Method Change in patient/caregiver decision making self-efficacy as measured by the Decision Self-efficacy Scale Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8) The Decision Self-efficacy Scale is a reliable and validated instrument that measures self-confidence or belief in one's abilities in decision making, including shared decision making (SDM). Items are summed, divided by 11, and multiplied by 25. Scores range from 0 to 100 (very confident).
Change in patient self-conflict as measured by the Decisional Conflict Scale Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8) The Decisional Conflict scale is a reliable and validated measure of the state of uncertainty about a course of action. Items are summed, divided by 16, and multiplied by 25. Scores range from 0 to 100 (high decisional conflict).
Change in patient/caregiver and provider preparedness for decision making as measured by the Preparation for Decision Making Scale Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8) The Preparation for Decision Making Scale is a reliable and validated self-reported measure of the patient/caregiver or provider's perception of how useful a decision support intervention is in preparing the respondent to communicate with others making a health decision. Items are summed and scored, then divided by 10; scores can be converted to a 0-100 scale. Higher scores indicate higher perceived level of preparation for decision making.
- Secondary Outcome Measures
Name Time Method Change in patient/caregiver and provider end of life (EOL) conversations as measured by EOL Conversations Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8) The EOL Conversations are author-developed questionnaires incorporating items from the Survey on Advanced Care Planning Conversations. Points are totaled and summed.
Change in provider end of life (EOL) care knowledge as measured by revised City of Hope EOL Knowledge Assessment Baseline, Post-Intervention (Week 4) The content of the City of Hope End of Life Knowledge Assessment was revised to reflect the program curriculum. Correctly answered questions will be awarded one point, summed, and a total score generated.
Change in patient and caregiver quality of life (QOL) as measured by the PROMIS Global Scale Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8) The PROMIS Global Scale is a reliable and validated measure of general perceptions of health. Items are predictive of care utilization and mortality. The scale produces two health scores: physical and mental. Items are summed and converted to t-scores.
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States