Four Conversations RCT

NCT ID: NCT02944344

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

357 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-15

Study Completion Date

2018-10-21

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Four Conversations Intervention

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

Group Type EXPERIMENTAL

Four Conversations

Intervention Type 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.

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.

Group Type OTHER

Four Conversations

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke Cancer Institute

OTHER

Sponsor Role collaborator

National Comprehensive Cancer Network

NETWORK

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Pillars4Life, Inc.

UNKNOWN

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophia K Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University School of Nursing

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35802350 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31638448 (View on PubMed)

Other Identifiers

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Pro00070790

Identifier Type: -

Identifier Source: org_study_id