Recruiting

mHealth

Sponsor:

University of Virginia

Code:

NCT03327103

Conditions

Decision Support Techniques

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

CHAMPION

Study Details

Brief summary:

Prostate cancer is a commonly diagnosed cancer, and is the second leading cause of cancer deaths among men in the U.S. The subgroup of men with advanced prostate cancer is particularly vulnerable to difficult choices for treatment because of the nature of their disease and having limited options. This study will test the use of an innovative Registered Nurse-Community Patient Navigator team delivered interactive mHealth decision aid for patients with advanced prostate cancer to help facilitate informed shared decisions about anti-cancer treatment that affects their quality of life.

Conditions

Decision Support Techniques

Study ID

NCT03327103

Start date

Jul 21, 2017

Status verified date

Oct, 2020

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 1) stages III/ IV prostate cancer 2) life expectancy ≥6 months 3) Karnofsky Performance Status >60 4) willingness of a DPP (patient selected person who provides decisional support) to participate 5) pair ages >18 years 6) ability to understand English

Exclusion Criteria:

  • severe psychiatric problems

Study Design

Enrollment

316 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Enhanced Usual Care

Receive standard care

experimental: Decision Intervention

Receives decision aid intervention that encompasses balance sheets, navigation, audio files, and interaction -- Cancer Health Aid to Manage Preferences and Improve Outcomes through Navigation (CHAMPION)

Interventions

CHAMPION

An interactive mHealth decision aid that includes immediate and over time quality of life (QL) graphical summaries for advanced prostate cancer patients to enhance informed, shared decision making and will also be used to assess the CPNs' role in the decision-making process.

Primary outcome measure

  • Decision Conflict, Decision Regret, and Prostate Cancer Symptom Scale [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Randy A Jones, PhD,RN,FAAN

434.924.0125raj9c@virginia.edu

Jane Gildersleeve, MSN

434.466.8109jlg2g@virginia.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Jennifer Wenzel, PhD,RN,FAAN

410-502-1114jwenzel@jhu.edu

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Randy A Jones, PhD,RN,FAAN

434-924-0125raj9c@virginia.edu

Jane Gildersleeve, MSN

434-243-3955jlg2g@virginia.edu

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Richard Brown, PhD

804-628-3340rbrown39@vcu.edu

More Information

Sponsor

University of Virginia

Last update posted

Oct 28, 2020

Last verified

Oct, 2020

Keywords

  • decision making
  • advanced prostate cancer
  • decision aid
  • minorities
  • mHealth
  • community patient navigator

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2020-10-28.