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OpenTrials
Completed

NCT Number: NCT02944344

Four Conversations RCT

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Death Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. Feasibility as measured by completion of advance directive documents

    Time frame: Post-Intervention (Week 4 or 8)

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

    Time frame: Post-Intervention (Week 4 or 8)

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

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

Registry information

Official study title

Four Conversations Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 25, 2016
Registry last updated
Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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