Four Conversations RCT

Study Overview
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Brief Summary
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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.

Official Title
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Four Conversations Randomized Controlled Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Four Conversations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: - None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Four Conversations Intervention<br>Subjects in this arm will participate in Reimagine's online Four Conversations program during the initial study period of four weeks. | Behavioral: Four Conversations<br>* The online Four Conversations program consists of tutorial videos, printable documents, and live sessions with a counselor to educate subjects on shared decision making and care planning for those with advanced disease.<br>|
| Other: Waitlisted Control<br>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. | Behavioral: Four Conversations<br>* The online Four Conversations program consists of tutorial videos, printable documents, and live sessions with a counselor to educate subjects on shared decision making and care planning for those with advanced disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient/caregiver and provider preparedness for decision making as measured by the Preparation for Decision Making Scale | 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. | Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8) | 
| Change in patient/caregiver decision making self-efficacy as measured by the Decision Self-efficacy Scale | 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). | Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8) | 
| Change in patient self-conflict as measured by the Decisional Conflict Scale | 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). | Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in provider end of life (EOL) care knowledge as measured by revised City of Hope EOL Knowledge Assessment | 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. | Baseline, Post-Intervention (Week 4) | 
| Change in patient and caregiver quality of life (QOL) as measured by the PROMIS Global Scale | 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. | Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8) | 
| Change in patient/caregiver and provider end of life (EOL) conversations as measured by EOL Conversations | The EOL Conversations are author-developed questionnaires incorporating items from the Survey on Advanced Care Planning Conversations. Points are totaled and summed. | Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, stage 4, metastatic, hospice, palliative care, end of life, advance directive, oncology, caregiver, provider, coping, support, online