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Decision Navigation for Advanced Prostate Cancer Treatment Options Using mHealth

NCT ID: NCT03327103

Last Updated: 2020-10-28

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-21

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Many patients with advanced prostate cancer along with their decision partners/ proxies (DPP) struggle with complex treatment decisions, such as when to start, change, or stop cancer directed treatment. Despite the utility of decision aids (DAs) to address decisional conflict, little is known about treatment decision-making for advanced cancers. The study's primary aim is to test the effects of a theory- based mHealth DA (CHAMPION) administered by Registered Nurse (RN)-Community Patient Navigator (CPN) teams to advanced prostate cancer patients and decision partners/proxies on the following outcomes: less decisional conflict/uncertainty, higher psychosocial quality of life domain (HRQL-PSY), and less regret at the time of making an anti-cancer treatment decision. The secondary aim is to evaluate the CPN role in delivery of the mHealth DA (CHAMPION) from the patients' and decision partners/proxies' perspective. Preliminary estimates of treatment effects by race to see if the data support a larger effect among African Americans versus Others in the primary and secondary aims will also be explored. This mixed-methods population-based randomized controlled trial will gather data from 158 patient/DPP pairs at three sites: University of Virginia Emily Couric Cancer Center, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, and Virginia Commonwealth University Massey Cancer Center. The pretest/posttest design will measure a time period that includes three single-event decisions over the course of their cancer-directed treatment; and a qualitative retrospective design will allow exploring the experiences of both patients and their DPPs separately in an interview at the completion of the study. Stratification by race (African-American and Caucasian/Other) and decision point (starting vs. changing vs. stopping anticancer treatment) will be used. There will be two groups: the control (enhanced usual care \[EUC\]) group and the decision intervention (DI) group. The DI group will receive an interactive 7-component cognitive-behavioral skills mHealth program (DA) with a RN-CPN team, primarily focusing on decision-making during cancer treatment. Self-report measures will be used for all participants in addition to probes for the taped interviews with DI. The primary outcome measures are 1) decisional conflict (uncertainty), 2) decisional regret, 3) HRQL-PSY, and 4) decision-making participation preference. Generalized linear models will be used for data analysis for the quantitative component, and qualitative evaluation of the intervention will be conducted to capture each pair's experience of the CHAMPION intervention. This innovative mHealth DA delivered by a CPN is expected to increase acceptability and the uptake of both the DA and the technology components. This addresses several NIH/NINR innovative questions, through the use of information technology to promote health-related decision-making for providers and patients, examining patient outcomes for improvement in healthcare, as well as to engage and support individuals such as extended family, lay coaches, etc. to augment provider care and recommendations.

Conditions

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Decision Support Techniques

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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Enhanced Usual Care

Receive standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

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)

Group Type EXPERIMENTAL

CHAMPION

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Randy A. Jones

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Randy A Jones, PhD,RN,FAAN

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status RECRUITING

University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Randy A Jones, PhD,RN,FAAN

Role: CONTACT

[email protected]
434.924.0125

Jane Gildersleeve, MSN

Role: CONTACT

[email protected]
434.466.8109

Facility Contacts

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Jennifer Wenzel, PhD,RN,FAAN

Role: primary

[email protected]
410-502-1114

Randy A Jones, PhD,RN,FAAN

Role: primary

[email protected]
434-924-0125

Jane Gildersleeve, MSN

Role: backup

[email protected]
434-243-3955

Richard Brown, PhD

Role: primary

[email protected]
804-628-3340

References

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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.

Reference Type DERIVED
PMID: 34530868 (View on PubMed)

Other Identifiers

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19402

Identifier Type: -

Identifier Source: org_study_id