Four Conversations RCT

NCT02944344

Last updated date
Study Location
Duke University Medical Center
Durham, North Carolina, 27710, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- None

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Advanced Information
Descriptive Information
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
  • Experimental: Four Conversations Intervention
    Subjects in this arm will participate in Reimagine's online Four Conversations program during the initial study period of four weeks.
    Intervention: Behavioral: Four Conversations
  • Waitlisted Control
    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.
    Intervention: Behavioral: Four Conversations
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
 (submitted: December 12, 2018)
357
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2016)
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:

  • 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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Plan to Share IPD:No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • Duke Cancer Institute
  • National Comprehensive Cancer Network
  • Pfizer
  • Pillars4Life, Inc.
Investigators  ICMJE
Principal Investigator:Sophia K Smith, PhDDuke University School of Nursing
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