scholarly journals Utilizing Digital Health to Collect Electronic Patient-Reported Outcomes in Prostate Cancer: Single-Arm Pilot Trial (Preprint)

2018 ◽  
Author(s):  
Christine Tran ◽  
Adam Dicker ◽  
Benjamin Leiby ◽  
Eric Gressen ◽  
Noelle Williams ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Cancer Treatment ◽  
Digital Literacy ◽  
Patient Reported Outcomes ◽  
Digital Health ◽  
Compliance Rate ◽  
Patient Reported ◽  
Literacy Level

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 <i>Strength Through Insight</i> 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 <i>Strength Through Insight</i> 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 <i>Strength Through Insight</i> 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 <i>Strength Through Insight</i> 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. CLINICALTRIAL ClinicalTrials.gov NC03197948; http://clinicaltrials.gov/ct2/show/NC03197948

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

10.2196/12689 ◽  
2020 ◽  
Vol 22 (3) ◽  
pp. e12689 ◽  
Author(s):  
Christine Tran ◽  
Adam Dicker ◽  
Benjamin Leiby ◽  
Eric Gressen ◽  
Noelle Williams ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Cancer Treatment ◽  
Digital Literacy ◽  
Patient Reported Outcomes ◽  
Digital Health ◽  
Compliance Rate ◽  
Patient Reported ◽  
Literacy Level

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

Quality-of-life outcomes for prostate cancer treatment in Australia.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 143-143
Author(s):  
Jeremy L. Millar ◽  
Susan M. Evans ◽  
Mark Frydenberg ◽  
Declan G. Murphy ◽  
Damien M. Bolton ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Cancer Treatment ◽  
Public Hospital ◽  
Population Based ◽  
Life Outcomes ◽  
Hospital Type ◽  
Prostate Cancer Treatment ◽  
Patient Reported

143 Background: We aimed to use a population based quality registry established in Australia, to review patient-reported health-related QOL after the diagnosis of Prostate Cancer (PCa). Methods: Prospective registry of men with PCa from statutory notifications to the canonical population-based cancer registry in Victoria. An "opt-off" mechanism used. Coverage expanded from 30%-80% of State population over time. Demographics and disease features, management, and outcomes from medical record; men phoned at 12 and 24 months (m), interviewed with script including SF12 and items from standard form (UCLA PCI) for specific QOL outcomes. Urinary, rectal, and sexual function bother (UB, RB, and SB) scores where analysed by univariate and multivariable modelling for relationship of these with presentation or management factors, adjusting for risk. Results: Men from 8/2008 - 2/2011; 1.9% of eligible opted out. Followed 1172 to 12 & 24 m. Median diagnosis age 65 yr; median PSA 6.8 ng/mL; 97.3% clinically localised with 47.7% having NCCN intermediate risk. 520 had treatment with Radical Prostatectomy (RP) (89 also with external beam-EBRT), 171 had EBRT (with or without HDR brachy), and 211 seed implant (SI). 226 had no treatment (NT) in the first 12 m. 52.5% managed in public hospitals, rest private. Univariate analysis: UB associated with management type, and hospital type, and RB and SB associated with these factors, as well as age and disease stage. On multivariate regression SB at 12 m was associated with increasing age (p=0.002) and radical treatment types (RP and EBRT/HDR, p<0.001 and 0.003 respectively)—except SI—compared to NT; RB was associated with SI (0.02) and EBRT/HDR (0.007) and treatment in a public hospital (0.006); and UB was associated with public hospital (<0.001). All associations at 12 m remained significant at 24 m. SF12 physical score had a positive association with RP vs NT (0.014), hospital type (0.001) and younger age. SF12 mental health also showed associations. Conclusions: A large scale registry in Australia assessing patient-reported quality of life outcomes after prostate cancer treatment shows patterns similar to that seen in North American reports.

Compliance of subjects using electronic patient-reported outcomes (ePRO) in multinational prostate trials.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 232-232
Author(s):  
Susan M. Dallabrida
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Quality Data ◽  
Data Set ◽  
Patient Reported ◽  
Clinic Visits

232 Background: Patient Reported Outcomes (PRO) and electronic PRO (ePRO) are increasingly becoming an important aspect of cancer clinical trials and patient care, especially with regard to measuring drug efficacy, patient quality of life and drug safety. Subject compliance with completion of PRO/ePRO assessments is an important component for obtaining accurate and high-quality data when conducting clinical trials. It has been hypothesized that patient health status, length of time in a trial and country of origin, may affect compliance. Methods: To address this hypothesis, an operational analysis was conducted to assess oncology subject completion compliance of PRO reports using an electronic tablet to determine its suitability and performance in use. Toward this objective, the compliance of prostate cancer patients in completing three electronic questionnaires that were administered at clinic visits was evaluated. Subjects were asked to complete the Brief Pain Inventory – Short Form (BPI-SF) at every clinic visit. At some clinic visits, subjects were asked to additionally complete the Functional Assessment of Cancer Therapy – Prostate (FACT-P) and the Euro Quality of Life 5 Dimensions (EQ-5D). Questionnaires were completed electronically on the tablet. Percent completion was calculated as the number of questionnaires completed divided by the number of questionnaires expected, based on attended clinic visits compiled for this review and the administration schedule for the questionnaires. Results: This review draws on the experience of over 1,000 subjects from 21 countries, and describes the individual and overall compliance with the expected questionnaire completion, the variance between subsequent visits, and compliance by country. Conclusions: The collection of ePRO using a clinic-based tablet yielded a highly complete data set in prostate cancer subjects demonstrating that this is an effective and feasible approach for recording symptoms and quality of life assessments.

Digital health application for real-time patient-reported outcomes during prostate radiotherapy.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 157-157 ◽  
Author(s):  
Daniel Xiao Yang ◽  
Jackson Thea ◽  
Yi An ◽  
James B. Yu
Keyword(s):  
Quality Of Life ◽  
Real Time ◽  
Mobile Applications ◽  
Mobile Application ◽  
Patient Reported Outcomes ◽  
Digital Health ◽  
Prostate Radiotherapy ◽  
Patient Reported

157 Background: The use of digital health technology, including mobile applications, in the clinical setting is becoming increasingly more prevalent. Such technology is currently being explored as clinical research tools. While the side effects of prostate radiotherapy are well documented after treatment, there remains a paucity of data on patient-reported outcomes and changes in quality of life (QOL) during the treatment period. Therefore, mobile applications represent a practical platform to enable patient reporting in real-time during prostate radiotherapy. Methods: Using an existing open source code framework (Apple ResearchKit), we developed a novel mobile application that enables prostate cancer patients to report, either during or immediately following daily radiation treatment, changes in urinary, bowel, sexual, and hormonal QOL domains. The mobile application utilizes validated questions from the Expanded Prostate Index Composite for Clinical Practice (EPIC-CP) Survey, and allows for survey responses to be tracked over time throughout the treatment period and at routine follow up. Results: For the initial phase of our study, we are currently piloting the mobile application at a single institution with a goal of accruing 50 patients. Study results will be compared to data from traditional surveys, which are available at follow-up but impracticable for real-time symptom reporting. By ASCO 2016 Genitourinary Cancers Symposium, we plan to begin the second phase of our study where any patient can enroll online through a mobile software distribution platform (Apple App Store). Conclusions: We demonstrate the feasibility of using a mobile application to enable patients to report quality of life changes in real-time during prostate radiotherapy. Moreover, our application facilitates clinical trials where patient data collection can be automated and completed at scale. Future prospective studies are planned to evaluate validity of clinical trial data gathered through such methodology.

Evaluating the correlation between early and late quality-of-life declines using the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) after definitive stereotactic body radiotherapy, intensity-modulated radiotherapy, or brachytherapy for prostate cancer.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 214-214
Author(s):  
Jacob Samuel Parzen ◽  
Thomas J Quinn ◽  
Andrew B Thompson ◽  
Peter Chang ◽  
Sean P. Collins ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Clinical Practice ◽  
Patient Reported Outcomes ◽  
Univariate Analysis ◽  
Intensity Modulated Radiotherapy ◽  
Late Toxicity ◽  
Intensity Modulated ◽  
Patient Reported

214 Background: Multiple authorities including an NCI Taskforce have recommended routine evaluation of patient reported outcomes (PRO) in cancer care. The Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) is a single-page quality-of-life (QOL) tool which is easily integrated into routine clinical practice. The EPIC-CP has 5 domains (each scored 0-12). The present study evaluated whether early clinically significant changes in EPIC-CP were correlated with later changes in patients undergoing definitive radiotherapy (RT) for prostate cancer. Methods: A cohort of 979 patients including the PROSTQA study and 3 other institutions with prospective QOL data pooled for analysis were evaluated for patient-reported outcomes. Patients were treated with definitive low-dose rate brachytherapy (n=284), intensity-modulated RT (n=251), or stereotactic body RT (n=444). EPIC-CP scores were derived based upon responses to the EPIC-26. Data were evaluated using minimal clinically important difference (MCID) thresholds to compare QOL at 1-2 months and 24 months from baseline. Univariate analysis was used to assess the correlation between early and late MCID changes. Results: On univariate analysis, early ≥1 MCID change from baseline was strongly associated with a late ≥1 MCID across all 5 domains (urinary incontinence, urinary irritation/obstruction, bowel, sexual, and vitality/hormonal) within EPIC-CP and for the overall EPIC-CP score (Table). When MCID was instead defined as 1 or 3, early toxicity remained predictive of late toxicity for all domains and the overall EPIC-CP score. Conclusions: The EPIC-CP is an easy-to-use QOL assessment with clinically relevant outcomes. Early QOL decline was strongly associated with late QOL decline in patients undergoing definitive RT for prostate cancer across all EPIC-CP domains. Patients with early QOL decline may be candidates for early QOL-based interventions to alleviate their late toxicity burden from treatment. [Table: see text]

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