Breast Cancer
Conditions
Keywords
breast cancer, stage 4, metastatic, hospice, palliative care, end of life, advance directive, oncology, caregiver, provider, coping, support, online
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.
Interventions
BEHAVIORALFour Conversations
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.
Sponsors
Duke Cancer Institute
National Comprehensive Cancer Network
Pfizer
Pillars4Life, Inc.
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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/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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as measured by the patient's completion of Reimagine's Worries to Wishes Treatment Plan | Post-Intervention (Week 4 or 8) | — |
| Feasibility as measured by satisfaction with Reimagine's Four Conversations program, as measured by the Program Satisfaction & Evaluation questionnaire | Post-Intervention (Week 4 or 8) | The Program Satisfaction & Evaluation questionnaire was developed by the study team to assess perceived helpfulness of the program in terms of outcomes and patient-provider communication. Points are totaled and summed. |
| Feasibility as measured by Reimagine's Four Conversations program usage, as measured by clickstream data from Reimagine's website and Reimagine staff report | Intervention period (4 weeks) | Clickstream data associated with viewing videos and other web content (e.g., social community) on the Reimagine website will be collected and analyzed through a web analytics software package. Session attendance will be collected by the Reimagine staff (specially trained counselors called Pillar Guides) and sent to the study team for analysis following each of the online meetings. |
| Feasibility as measured by completion of advance directive documents | Post-Intervention (Week 4 or 8) | — |
Countries
United States
Outcome results
None listed