# Decision Navigation for Advanced Prostate Cancer Treatment Options using mHealth

> **NIH NIH R01** · UNIVERSITY OF VIRGINIA · 2020 · $542,846

## Abstract

PROJECT SUMMARY. 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 patient...

## Key facts

- **NIH application ID:** 9829583
- **Project number:** 5R01NR016483-04
- **Recipient organization:** UNIVERSITY OF VIRGINIA
- **Principal Investigator:** RANDY ALLEN JONES
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $542,846
- **Award type:** 5
- **Project period:** 2017-02-06 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9829583

## Citation

> US National Institutes of Health, RePORTER application 9829583, Decision Navigation for Advanced Prostate Cancer Treatment Options using mHealth (5R01NR016483-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9829583. Licensed CC0.

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