Decision Navigation for Advanced Prostate Cancer Treatment Options Using mHealth

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.

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