Decision Navigation for Advanced Prostate Cancer Treatment Options Using mHealth

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.

Study Overview

• Status: Unknown
• Conditions: Decision Support Techniques
• Intervention / Treatment: Behavioral: CHAMPION

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 316
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Randy A Jones, PhD,RN,FAAN; Phone Number: 434.924.0125; Email: raj9c@virginia.edu
• Study Contact Backup: Name: Jane Gildersleeve, MSN; Phone Number: 434.466.8109; Email: jlg2g@virginia.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Johns Hopkins University
      • Contact: Jennifer Wenzel, PhD,RN,FAAN; Phone Number: 410-502-1114; Email: jwenzel@jhu.edu
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia
      • Contact: Randy A Jones, PhD,RN,FAAN; Phone Number: 434-924-0125; Email: raj9c@virginia.edu
      • Contact: Jane Gildersleeve, MSN; Phone Number: 434-243-3955; Email: jlg2g@virginia.edu
    • Richmond, Virginia, United States, 23219
      • Recruiting
      • Virginia Commonwealth University
      • Contact: Richard Brown, PhD; Phone Number: 804-628-3340; Email: rbrown39@vcu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
semi-structured interview	evaluate community patient navigator role in delivery of decision aid	9 months

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: Johns Hopkins University; Virginia Commonwealth University
• Investigators: Principal Investigator: Randy A Jones, PhD,RN,FAAN, University of Virginia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2017
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: mHealth; advanced prostate cancer; decision making; decision aid; minorities; community patient navigator
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 19402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No