NCT03327103

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
316

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

4.4 years

First QC Date

October 26, 2017

Last Update Submit

October 26, 2020

Conditions

Decision Support Techniques

Keywords

decision makingadvanced prostate cancerdecision aidminoritiesmHealthcommunity patient navigator

Outcome Measures

Primary Outcomes (1)

  • Decision Conflict, Decision Regret, and Prostate Cancer Symptom Scale

    demonstrate less decisional conflict/uncertainty, higher QL (HRQL-PSY domain) and less regret at the time of making an anti-cancer treatment decision

    9 months

Secondary Outcomes (1)

  • semi-structured interview

    9 months

Study Arms (2)

Enhanced Usual Care

NO INTERVENTION

Receive standard care

Decision Intervention

EXPERIMENTAL

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)

Behavioral: CHAMPION

Interventions

CHAMPIONBEHAVIORAL

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.

Decision Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) 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

You may not qualify if:

  • severe psychiatric problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

RECRUITING

Related Publications (1)

  • Carhuapoma LR, Thayer WM, Elmore CE, Gildersleeve J, Singh T, Shaukat F, Uveges MK, Gray T, Chu C, Song D, Hollen PJ, Wenzel J, Jones RA. Employing a mobile health decision aid to improve decision-making for patients with advanced prostate cancer and their decision partners/proxies: the CHAMPION randomized controlled trial study design. Trials. 2021 Sep 16;22(1):631. doi: 10.1186/s13063-021-05602-0.

    PMID: 34530868DERIVED

Study Officials

  • Randy A Jones, PhD,RN,FAAN

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Randy A Jones, PhD,RN,FAAN

CONTACT

434.924.0125raj9c@virginia.edu

Jane Gildersleeve, MSN

CONTACT

434.466.8109jlg2g@virginia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 26, 2017

First Posted

October 31, 2017

Study Start

July 21, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

October 28, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(3)