ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Four Conversations RCT | |||
Official Title ICMJE | Four Conversations Randomized Controlled Trial | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care | |||
Condition ICMJE | Breast Cancer | |||
Intervention ICMJE | Behavioral: Four 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. | |||
Study Arms ICMJE |
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Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 357 | |||
Original Estimated Enrollment ICMJE | 250 | |||
Actual Study Completion Date ICMJE | October 21, 2018 | |||
Actual Primary Completion Date | October 21, 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - None | |||
Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02944344 | |||
Other Study ID Numbers ICMJE | Pro00070790 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Duke University | |||
Study Sponsor ICMJE | Duke University | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Duke University | |||
Verification Date | December 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |