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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.
This study explored the feasibility and acceptability of collecting ePROs using validated health-related quality of life (HRQoL) questionnaires for prostate cancer.
Using Apple ResearchKit software, the
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.
ClinicalTrials.gov NC03197948; http://clinicaltrials.gov/ct2/show/NC03197948
As hospitals seek to provide better value in health care, patient-reported outcome measures (PROMs), such as those evaluating pain and distress, are an integral part of improving care. Patient-reported outcomes (PROs) can serve as an innovative way for providers to incentivize patients to make changes that facilitate patient engagement and self-care for chronic disease management and prevention [
With the widespread adoption of smartphones, tablets, and other smart devices, mobile apps provide a new platform for patients to become active members of their health care team. Digital health technology encompasses clinical tools, advanced statistical algorithms, cloud computing, and artificial intelligence [
The objective of this study was to test the feasibility and acceptability of
To our knowledge, this is the first study piloting an ePRO using the ResearchKit smartphone app platform for patients with prostate cancer. The study (1) tested the feasibility of collecting ePROs via a digital health app, with a validated HRQoL questionnaires for patients undergoing prostate cancer treatment, and (2) analyzed patient attitudes and perceptions through qualitative interviews to identify reoccurring themes that address facilitators and barriers of adopting digital health to best support future design and implementation of digital health technology. We hypothesized that more than 80% of patients will complete 60% of the HRQoL questionnaires, once a week for a period of 12 weeks, proving the feasibility of ePROs in a smartphone app.
This feasibility study was conducted at the Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital (TJUH). Following TJUH institutional review board approval, potential participants were identified through a database maintained by the Sidney Kimmel Cancer Center.
The study was made available on the ClinicalTrials.gov [
The study investigators developed patient interview guide questions based on clinical experience and relevant literature. The guide consisted of questions regarding patients’ expectations and experiences throughout prostate cancer treatment, which was defined for participants as encompassing symptom management (perceived knowledge about treatment side effects), patient-physician communication, digital literacy, quality of life, social media, and patient satisfaction.
Eligible patients were patients with prostate cancer who were receiving follow-up care (including follow-up and newly diagnosed patients). Inclusion criteria included (1) aged 18 years or older, (2) self-reported ability to speak and read English, (3) ability to communicate on a touch screen iPhone, (4) willing to provide signed informed consent, (5) willing and able to comply with all study activities, and (6) access to Wi-Fi connection or cellular data. Exclusion criteria included (1) subjects with concurrent medical or psychiatric condition who may have precluded participation in this study or completion of self-administered questionnaires (eg, moderate to severe dementia and/or severe, uncontrolled schizophrenia or other conditions that would render them unable to complete a questionnaire) and (2) cognitive or other impairment (eg, visual) that would interfere with completing a self-administered questionnaire on an iPhone.
The NCI Symptom Management and Health-Related Quality of Life Steering Committee recommend core sets of PROs to be routinely incorporated in prostate cancer treatment. This effort suggested 5 domains for localized prostate cancer (urinary incontinence, urinary obstruction and irritation, bowel-related symptoms, sexual dysfunction, and hormonal symptoms) and 4 domains for advanced prostate cancer (pain, fatigue, mental well-being, and physical well-being) [
Participants were asked to complete the EPIC demographic add-on survey in the smartphone app, which included information on the participant’s ethnicity, marital status, employment, smoking status, previous treatments for prostate cancer, other current medical conditions, education, and income. Participants were then asked to self-select a survey option (survey A or survey B) based on the stage of their cancer [
Screenshot representations of the
The feasibility of the
Participants were asked to take part in guided interviews via telephone or in-clinic during visits before completing their first assessment. Separate interviews were held at the end of the study to facilitate feedback on
Pre- and postinterview questionnaires are provided in
A total of 29 patients with prostate cancer participated in the study from August 1, 2016, to December 31, 2017. The main reason for ineligibility was because of owning an Android device, and common causes for participant refusal were unwillingness to download the app, unable to remember iOS password (required to download apps), lack of knowledge concerning apps, and concern of data security. As shown in
Sociodemographic and clinical characteristics of participants (N=29).
Characteristics | Values | |
Age (years), median (range) | 55 (45-70) | |
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White | 29 (100) |
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Married | 19 (66) |
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College | 29 (100) |
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≥$30,000 | 29 (100) |
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Localized prostate cancer | 25 (86) |
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Advanced prostate cancer | 4 (14) |
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High | 8 (27) |
A total of 29 participants enrolled in the study. Of these 86% (25/29) reached satisfactory questionnaire completion (defined as completion of 60% of weekly questions over 12 weeks). The lower bound of the exact 1-sided 95% CI was 71%, exceeding the 70% feasibility threshold. All participants were able to complete informed consent through the smartphone app. Patterns of missing data showed a decline in responses after week 6. Moreover, 3 participants reported technical issues (app randomly closing/needing to restart the app) as the main reason for missing questions. Of 29, 90% (26/29) participants self-identified with localized disease chose to opt in push notifications. These participants reported push notifications to be an effective tool as a passive reminder to monitor their health. However, patients with advanced disease preferred not to have push notifications because of the patient belief that the notifications served as reminders of their health status or poor quality of life.
Overall, 72% (21/29) involved in testing the feasibility of the
“Every time I saw the notification on my phone, even if I didn’t automatically go to the app and answer the questionnaire, it made me think of how I’m doing. And if I had a question about something I was feeling, I go to Dr. Google and search for my symptoms and look at forums from people to see if I can find someone like me.”
“I thought it was great! I would be interested on using it for the rest of my treatment because you can’t remember everything, it’s hard to bring up anyways because my visits are so fast paced. I think my doctor gets really defensive every time I come in with my sheets.”
“My wife and I actually answered the questions together as a little ritual at the end of the week. We had long talks about some of it because she made me change my answers to some questions.”
“Some of the questions were just too general or repetitive. It wasn’t specific to me and I wish there were more questions about my pain management. I had issues that were worsened by surgery.”
Analysis of interview data revealed 4 dominant digital health themes: (1) the value of emotional support and wellness in cancer treatment, (2) rise of social patient advocacy in online patient communities (OPCs) and networks, (3) concerns over privacy and privacy as a social norm, and (4) the need for personalized digital health to improve patient engagement.
Analysis revealed repeated reference to how
The particular role of social media through OPCs and networks was emphasized as a recurring topic. Several participants identified the use of patient communities, such as Facebook groups, the smartphone app
Nearly all participants emphasized a concerning issue of how patient-generated data would be used in the future. Participants identified the lack of transparency regarding current and future use of data as a major concern. Several participants also noted that despite potential disagreement on how information will be used or clarity of data ownership, they are likely to consent to health apps regardless because they will not be able to benefit from digital health technology otherwise.
Almost all patients reported predictive information as an encouragement to participate in their health care and acknowledged a desire for the app to be supported through predictive analytics to help drive engagement and healthy behavior change. Several participants specifically asked for an app upgrade that included a data summary component, showing data analytics to capture a higher level of detail necessary to predict and personalize symptoms if asked to continue app use. A summary of the qualitative themes has been illustrated in
“I’d rather an app pay attention to how I’m doing emotionally. Weeks go by and I still end up sleeping the day or weekend away because I’m depressed and tired. I avoided seeing anyone and used symptoms I didn’t even have as an excuse.”
“I don’t know if I was depressed. I’m a proud person and didn’t let anyone know how I was feeling really. But my doctor didn’t even ask. Maybe they need input from other departments.”
“I’ve changed doctors three times, so I know I like my doctor. But I was disappointed because he made me feel confident that I would only experience certain symptoms. Then 3-4 months down the road, I never thought I would have the pain or some side effects I have now. I wasn’t told of anything really.”
“I go on there because I’m interested and want to know more and those are the people I want to talk to. They make me feel like I can take my life back and move on.”
“It’s hard to trust. We don’t have the same type of security on the internet than we do in the real-world. Especially with companies, I don’t believe they have my best interest in mind. I don’t see my opinion changing.”
“Without some kind of data analysis, I feel like I’m just the product giving you information, not the consumer.”
The aim of this study was to explore the feasibility and acceptability of collecting ePROs using validated HRQoL assessment tools through a smartphone app in adult men throughout their course of treatment for prostate cancer. This study found that 86% (25/29) of participants reached satisfactory questionnaire completion (defined as completion of 60% of weekly questions over 12 weeks), proving the feasibility of collecting ePROs through a digital health app. Patients reported skipping domain-specific questions (urinary incontinence and irritation/obstruction items, along with bowel, sexual, and vitality/hormonal domains) that did not apply to the particular individual. Although higher completion rates over time would be desirable, the study was unable to observe this. This may be because of the lack of feedback to the user regarding their previous answers to the questionnaire. In this regard, the study did not originally consider patient feedback and was one of the learning points the authors were able to extract from this study. Overall, the use of ePROs may improve the quality of routine cancer care by expediting the detection of severe or disabling toxicities [
A primary theme that emerged from the interviews emphasized the value of emotional support and wellness in cancer treatment. Patient interviews highlighted the importance of emotional well-being as an unaddressed side effect of cancer treatment that is dealt with every day, as opposed to the appearance of occasional symptoms. This demonstrates another impactful way digital health can deliver care to meet a patients’ need within an empowerment framework.
A second major theme was concerned with the importance of providers to engage patients in participatory medicine with shared decision making. As a result of this lack of engagement, patients have resorted to social networking platforms such as OPCs. OPCs and networks are known for the arrangement and abundance of information, which enable patients to make treatment decisions that correspond with their long-term goals [
A third major theme that emerged puts forward an important fundamental question in digital health and how patients can benefit from data while protecting their privacy. Patient concerns over privacy, confidentiality, and control of data represent a growing recognition that patient-generated data from digital health tools can potentially be used for wanted and unwanted outcomes. Without public policy regulation concerning the ownership and responsibility for patient-generated data, digital health continues to lack transparency over the control of data, along with its implication for advanced analytics [
A fourth major theme indicated the inefficiency of digital health interventions unless appropriately acted on by patients. Nearly all patients reported a desire to become more involved with their health care through data personalization and predictive analytics. Lessons learned from the compliance rate of
A limitation of the study included the lack of a diverse patient population, which may not be representative of all patients with prostate cancer. The limited population may be reflected of a
In the last few years, the health care industry has been promoting the concept of providers and patients collaborating and communicating with each other as a powerful tool. This has led to an evolving model of consumerism and a desire of patients to become engaged in their own health care decisions, delivery, and interactions. As the digital era progresses, digital health may serve as an enabler of patient-provider engagement, extending care beyond the confines of the hospital system and meeting consumers on their own terms. Digital platforms can engage consumers in a variety of ways, including tracking medical progress, treatment adherence, reminders and scheduling, and communications and providing the ability to capture more comprehensive data for analysis. However, despite the benefits of desire, many digital health technologies face the challenge of personalization, as health care has historically taken a one size fits all approach to patient engagement using the same context and communication channel for every patient. Future technology must focus on each patient as a unique individual, with his or her own motivations, priorities, and communication preferences. Moreover, the health care industry has the opportunity to improve on traditional mass approaches to patient communication by leveraging lessons learned in both the retail and financial industries [
The health care community has long recognized the value of a patients’ input in describing their own experiences, which has led to the growing use of ePROs to improve the efficiency of data collection and provide new opportunities to bring meaningful evidence back to patients and providers in innovative ways. This research provided an in-depth perspective on the different aspects of implementing ePROs on a digital health platform. To our knowledge, this was the first study piloting an ePRO using the ResearchKit smartphone app platform for patients with prostate cancer and expands on the research proving the feasibility and rigor of ePROs. With this, the true 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.
Preinterview questions.
Postinterview questions.
adverse event
26-item Expanded Prostate Cancer Index Composite
Expanded Prostate Cancer Index Composite for Clinical Practice
electronic patient-reported outcome
8-item Functional Assessment of Cancer Therapy Advanced Prostate Symptom Index
health-related quality of life
National Cancer Institute
patient-reported outcome
Thomas Jefferson University Hospital
AD was supported by the Jefferson Center for Digital Health & Data Science, Transdisciplinary Integrated Population Science Program of the Sidney Kimmel Cancer Center, and a Challenge Grant from the Prostate Cancer Foundation. The authors would also like to acknowledge the support of Nathan Vecchiarelli (Senior Software Engineer), James Fasoline (DevOps Engineer), Samuel Halperin (Software Engineer), and Raul Staricco (Senior Experience Designer) for app design and development [
None declared.