Four Conversations RCT

NCT02944344 | Completed

• 1 other identifier: Pro00070790
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; stage 4; metastatic; hospice; palliative care; end of life; advance directive; oncology; caregiver; provider; coping; support; online

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (3)

• Change in provider end of life (EOL) care knowledge as measured by revised City of Hope EOL Knowledge Assessment

  Baseline, Post-Intervention (Week 4)

• Change in patient and caregiver quality of life (QOL) as measured by the PROMIS Global Scale

  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

  Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)

Other Outcomes (4)

• Feasibility as measured by completion of advance directive documents

  Post-Intervention (Week 4 or 8)

• Feasibility as measured by the patient's completion of Reimagine's Worries to Wishes Treatment Plan

  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

  Intervention period (4 weeks)

Study Arms (2)

Four Conversations Intervention

EXPERIMENTAL

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

Behavioral: Four Conversations

Waitlisted Control

OTHER

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

Interventions

Four Conversations BEHAVIORAL

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.

Four Conversations Intervention; Waitlisted Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Duke University: lead
• Duke Cancer Institute: collaborator
• National Comprehensive Cancer Network: collaborator
• Pfizer: collaborator
• Pillars4Life, Inc.: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

• 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.

  PMID: 35802350 DERIVED

• 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.

  PMID: 31638448 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Death; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sophia K Smith, PhD

  Duke University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 25, 2016
• Study Start: December 15, 2016
• Primary Completion: October 21, 2018
• Study Completion: October 21, 2018
• Last Updated: December 13, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)