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| Name | Class |
|---|---|
| Duke Cancer Institute | OTHER |
| National Comprehensive Cancer Network | NETWORK |
| Pfizer | INDUSTRY |
| Pillars4Life, Inc. |
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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 Conversationsâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Four Conversations Intervention | Experimental | Subjects in this arm will participate in Reimagine's online Four Conversations program during the initial study period of four weeks. |
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| Waitlisted Control | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Four Conversations | Behavioral | 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. |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as measured by completion of advance directive documents | Post-Intervention (Week 4 or 8) | |
| Feasibility as measured by the patient's completion of Reimagine's Worries to Wishes Treatment Plan | Post-Intervention (Week 4 or 8) |
Inclusion Criteria:
Exclusion Criteria:
- None
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| Name | Affiliation | Role |
|---|---|---|
| Sophia K Smith, PhD | Duke University School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35802350 | Derived | Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2. | |
| 31638448 | Derived |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| D003643 | Death |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| UNKNOWN |
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| 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) |
| Feasibility as measured by Reimagine's Four Conversations program usage, as measured by clickstream data from Reimagine's website and Reimagine staff report | 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. | Intervention period (4 weeks) |
| Feasibility as measured by satisfaction with Reimagine's Four Conversations program, as measured by the Program Satisfaction & Evaluation questionnaire | 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. | Post-Intervention (Week 4 or 8) |
| Smith SK, Westbrook K, MacDermott K, Amarasekara S, LeBlanc M, Pan W. Four Conversations: A Randomized Controlled Trial of an Online, Personalized Coping and Decision Aid for Metastatic Breast Cancer Patients. J Palliat Med. 2020 Mar;23(3):353-358. doi: 10.1089/jpm.2019.0234. Epub 2019 Oct 22. |
| D009385 |
| Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |