Clinical trial NCT02944344: Four Conversations RCT
Official title: Four Conversations Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
stage 4
metastatic
hospice
palliative care
end of life
advance directive
oncology
caregiver
provider
coping
support
online
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Cancer Institute
name: National Comprehensive Cancer Network
name: Pfizer
name: Pillars4Life, Inc.
First posted: 2016-10-25
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in patient/caregiver and provider preparedness for decision making as measured by the Preparation for Decision Making Scale
timeFrame: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
measure: Change in patient/caregiver decision making self-efficacy as measured by the Decision Self-efficacy Scale
timeFrame: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
measure: Change in patient self-conflict as measured by the Decisional Conflict Scale
timeFrame: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
Secondary outcomes:
measure: Change in provider end of life (EOL) care knowledge as measured by revised City of Hope EOL Knowledge Assessment
timeFrame: Baseline, Post-Intervention (Week 4)
measure: Change in patient and caregiver quality of life (QOL) as measured by the PROMIS Global Scale
timeFrame: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
measure: Change in patient/caregiver and provider end of life (EOL) conversations as measured by EOL Conversations
timeFrame: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
Other outcomes:
measure: Feasibility as measured by completion of advance directive documents
timeFrame: Post-Intervention (Week 4 or 8)
measure: Feasibility as measured by the patient's completion of Reimagine's Worries to Wishes Treatment Plan
timeFrame: Post-Intervention (Week 4 or 8)
measure: Feasibility as measured by Reimagine's Four Conversations program usage, as measured by clickstream data from Reimagine's website and Reimagine staff report
timeFrame: Intervention period (4 weeks)
measure: Feasibility as measured by satisfaction with Reimagine's Four Conversations program, as measured by the Program Satisfaction & Evaluation questionnaire
timeFrame: Post-Intervention (Week 4 or 8)
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Sophia K Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.