Four Conversations RCT

December 12, 2018 updated by: Duke University

Four Conversations Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

357

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient/caregiver and provider preparedness for decision making as measured by the Preparation for Decision Making Scale
Time Frame: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
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
Time Frame: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
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
Time Frame: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in provider end of life (EOL) care knowledge as measured by revised City of Hope EOL Knowledge Assessment
Time Frame: Baseline, Post-Intervention (Week 4)
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)
Change in patient and caregiver quality of life (QOL) as measured by the PROMIS Global Scale
Time Frame: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
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
Time Frame: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility as measured by completion of advance directive documents
Time Frame: Post-Intervention (Week 4 or 8)
Post-Intervention (Week 4 or 8)
Feasibility as measured by the patient's completion of Reimagine's Worries to Wishes Treatment Plan
Time Frame: Post-Intervention (Week 4 or 8)
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
Time Frame: Intervention period (4 weeks)
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
Time Frame: Post-Intervention (Week 4 or 8)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Pfizer
National Comprehensive Cancer Network
Duke Cancer Institute
Pillars4Life, Inc.

Investigators

  • Principal Investigator: Sophia K Smith, PhD, Duke University School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2016

Primary Completion (Actual)

October 21, 2018

Study Completion (Actual)

October 21, 2018

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimate)

October 25, 2016

Study Record Updates

Last Update Posted (Actual)

December 13, 2018

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00070790

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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