Four Conversations RCT

Breast Cancer Clinical Trial

Official title:

Four Conversations Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02944344
• Other study ID #: Pro00070790
• Status: Completed
• Phase: N/A
• Start date: December 15, 2016
• Est. completion date: October 21, 2018

Study information

• Verified date: December 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: October 21, 2018
• Est. primary completion date: October 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (5)

Lead Sponsor	Collaborator
Duke University	Duke Cancer Institute, National Comprehensive Cancer Network, Pfizer, Pillars4Life, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility as measured by completion of advance directive documents		Post-Intervention (Week 4 or 8)
Other	Feasibility as measured by the patient's completion of Reimagine's Worries to Wishes Treatment Plan		Post-Intervention (Week 4 or 8)
Other	Feasibility as measured by Reimagine's Four Conversations program usage, as measured by clickstream data from Reimagine's website and Reimagine staff report	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)
Other	Feasibility as measured by satisfaction with Reimagine's Four Conversations program, as measured by the Program Satisfaction & Evaluation questionnaire	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)
Primary	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.	Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
Primary	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).	Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
Primary	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).	Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
Secondary	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.	Baseline, Post-Intervention (Week 4)
Secondary	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.	Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
Secondary	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.	Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)