Utilizing Digital Health to Collect Electronic Patient-Reported Outcomes in Prostate Cancer: Single-Arm Pilot Trial

Background: Measuring patient-reported outcomes (PROs) requires an
individual’s perspective on their symptoms, functional status,
and quality of life. Digital health enables remote electronic PRO
(ePRO) assessments as a clinical decision support tool to
facilitate meaningful provider interactions and personalized
treatment. Objective: This study explored the feasibility and
acceptability of collecting ePROs using validated health-related
quality of life (HRQoL) questionnaires for prostate cancer.
Methods: Using Apple ResearchKit software, the Strength Through
Insight app was created with content from validated HRQoL tools
26-item Expanded Prostate Cancer Index Composite (EPIC) or EPIC for
Clinical Practice and 8-item Functional Assessment of Cancer
Therapy Advanced Prostate Symptom Index. In a single-arm pilot
study with patients receiving prostate cancer treatment at Thomas
Jefferson University Hospital and affiliates, participants were
recruited, and instructed to download Strength Through Insight and
complete ePROs once a week over 12 weeks. A mixed methods approach,
including qualitative pre- and poststudy interviews, was used to
evaluate the feasibility and acceptability of Strength Through
Insight for the collection and care management of cancer treatment.
Results: Thirty patients consented to the study; 1 patient failed
to complete any of the questionnaires and was left out of the
analysis of the intervention. Moreover, 86% (25/29) reached
satisfactory questionnaire completion (defined as completion of 60%
of weekly questions over 12 weeks). The lower bound of the exact
one-sided 95% CI was 71%, exceeding the 70% feasibility threshold.
Most participants self-identified with having a high digital
literacy level (defined as the ability to use, understand,
evaluate, and analyze information from multiple formats from a
variety of digital sources), and only a few participants identified
with having a low digital literacy level (defined as only having
the ability to gather information on the Web). Interviews were
thematically analyzed to reveal the following: (1) value of
emotional support and wellness in cancer treatment, (2) rise of
social patient advocacy in online patient communities and networks,
(3) patient concerns over privacy, and (4) desire for personalized
engagement tools. Conclusions: Strength Through Insight was
demonstrated as a feasible and acceptable method of data collection
for ePROs. A high compliance rate confirmed the app as a reliable
tool for patients with localized and advanced prostate cancer.
Nearly all participants reported that using the smartphone app is
easier than or equivalent to the traditional paper-and-pen
approach, providing evidence of acceptability and support for the
use of remote PRO monitoring. This study expands on current
research involving the value of digital health, as a social and
behavioral science, augmented with technology, can begin to
contribute to population health management, as it shapes
psychographic segmentation by demographic, socioeconomic, health
condition, or behavioral factors to group patients by their
distinct personalities and motivations, which influence their
choices. Trial Registration: ClinicalTrials.gov NC03197948;
http://clinicaltrials.gov/ct2/show/NC03197948

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Utilizing Digital Health to Collect Electronic Patient-Reported Outcomes in Prostate Cancer: Single-Arm Pilot Trial