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Four Conversations RCT

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Four Conversations
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, stage 4, metastatic, hospice, palliative care, end of life, advance directive, oncology, caregiver, provider, coping, support, online

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Four Conversations Intervention

Waitlisted Control

Arm Description

Subjects in this arm will participate in Reimagine's online Four Conversations program during the initial study period of four weeks.

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.

Outcomes

Primary Outcome Measures

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.
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).
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).

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 24, 2016
Last Updated
December 12, 2018
Sponsor
Duke University
Collaborators
Duke Cancer Institute, National Comprehensive Cancer Network, Pfizer, Pillars4Life, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02944344
Brief Title
Four Conversations RCT
Official Title
Four Conversations Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 15, 2016 (Actual)
Primary Completion Date
October 21, 2018 (Actual)
Study Completion Date
October 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Duke Cancer Institute, National Comprehensive Cancer Network, Pfizer, Pillars4Life, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, stage 4, metastatic, hospice, palliative care, end of life, advance directive, oncology, caregiver, provider, coping, support, online

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
357 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Four Conversations Intervention
Arm Type
Experimental
Arm Description
Subjects in this arm will participate in Reimagine's online Four Conversations program during the initial study period of four weeks.
Arm Title
Waitlisted Control
Arm Type
Other
Arm Description
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 Type
Behavioral
Intervention Name(s)
Four Conversations
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in patient/caregiver and provider preparedness for decision making as measured by the Preparation for Decision Making Scale
Description
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.
Time Frame
Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
Title
Change in patient/caregiver decision making self-efficacy as measured by the Decision Self-efficacy Scale
Description
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).
Time Frame
Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
Title
Change in patient self-conflict as measured by the Decisional Conflict Scale
Description
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).
Time Frame
Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
Secondary Outcome Measure Information:
Title
Change in provider end of life (EOL) care knowledge as measured by revised City of Hope EOL Knowledge Assessment
Description
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.
Time Frame
Baseline, Post-Intervention (Week 4)
Title
Change in patient and caregiver quality of life (QOL) as measured by the PROMIS Global Scale
Description
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.
Time Frame
Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
Title
Change in patient/caregiver and provider end of life (EOL) conversations as measured by EOL Conversations
Description
The EOL Conversations are author-developed questionnaires incorporating items from the Survey on Advanced Care Planning Conversations. Points are totaled and summed.
Time Frame
Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
Other Pre-specified Outcome Measures:
Title
Feasibility as measured by completion of advance directive documents
Time Frame
Post-Intervention (Week 4 or 8)
Title
Feasibility as measured by the patient's completion of Reimagine's Worries to Wishes Treatment Plan
Time Frame
Post-Intervention (Week 4 or 8)
Title
Feasibility as measured by Reimagine's Four Conversations program usage, as measured by clickstream data from Reimagine's website and Reimagine staff report
Description
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.
Time Frame
Intervention period (4 weeks)
Title
Feasibility as measured by satisfaction with Reimagine's Four Conversations program, as measured by the Program Satisfaction & Evaluation questionnaire
Description
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.
Time Frame
Post-Intervention (Week 4 or 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophia K Smith, PhD
Organizational Affiliation
Duke University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35802350
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.
Results Reference
derived
PubMed Identifier
31638448
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.
Results Reference
derived

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Four Conversations RCT

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