Dataset Information

Electronic-Based Patient-Reported Outcomes: Willingness, Needs, and Barriers in Adjuvant and Metastatic Breast Cancer Patients.

ABSTRACT: Patient-reported outcomes (PROs) play an increasingly important role as an adjunct to clinical outcome parameters in measuring health-related quality of life (HRQoL). In fact, PROs are already the accepted gold standard for collecting data about patients' subjective perception of their own state of health. Currently, paper-based surveys of PRO still predominate; however, knowledge regarding the feasibility of and barriers to electronic-based PRO (ePRO) acceptance remains limited.The objective of this trial was to analyze the willingness, specific needs, and barriers of adjuvant breast cancer (aBC) and metastatic breast cancer (mBC) patients in nonexposed (no exposure to electronic assessment) and exposed (after exposure to electronic assessment decision, whether a tablet-based questionnaire is favored) settings before implementing digital ePRO assessment in relation to health status. We also investigated whether providing support can increase the patients' willingness to participate in such programs.The nonexposed patients only answered a paper-based questionnaire, whereas the exposed patients filled out both paper- and tablet-based questionnaires. The assessment comprised socioeconomic variables, HRQoL, preexisting technical skills, general attitude toward electronic-based surveys, and potential barriers in relation to health status. Furthermore, nonexposed patients were asked about the existing need for technological support structures. In the course of data evaluation, we performed a frequency analysis as well as chi-square tests and Wilcoxon signed-rank tests. Subsequently, relative risks analysis, univariate categorical regression (CATREG), and mediation analyses (Hayes' bias-corrected bootstrap) were performed.A total of 202 female breast cancer patients completed the PRO assessment (nonexposed group: n=96 patients; exposed group: n=106 patients). Self-reported technical skills were higher in exposed patients (2.79 vs 2.33, P ?.001). Significant differences were found in relation to willingness to use ePRO (92.3% in the exposed group vs 59% in the nonexposed group; P=.001). Multiple barriers were identified, and most of them showed statistically significant differences in favor of the exposed patients (ie, data security [13% in the exposed patients vs 30% in the nonexposed patients; P=.003] and no prior technology usage [5% in the exposed group vs 15% in the nonexposed group; P=.02]), whereas the differences in disease burden (somatic dimension: 4% in the exposed group vs 9% in the nonexposed group; P=.13) showed no significance. In nonexposed patients, requests for support services were identified, which could increase their ePRO willingness.Significant barriers in relation to HRQoL, cancer-related restrictions, and especially the setting of the survey were identified in this trial. Thus, it is necessary to address and eliminate these barriers to ensure data accuracy and reliability for future ePRO assessments. Exposure seems to be a potential option to increase willingness to use ePRO and to reduce barriers.

SUBMITTER: Hartkopf AD

PROVIDER: S-EPMC5565790 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Electronic-Based Patient-Reported Outcomes: Willingness, Needs, and Barriers in Adjuvant and Metastatic Breast Cancer Patients.

Hartkopf Andreas D AD Graf Joachim J Simoes Elisabeth E Keilmann Lucia L Sickenberger Nina N Gass Paul P Wallwiener Diethelm D Matthies Lina L Taran Florin-Andrei FA Lux Michael P MP Wallwiener Stephanie S Belleville Eric E Sohn Christof C Fasching Peter A PA Schneeweiss Andreas A Brucker Sara Y SY Wallwiener Markus M

JMIR cancer 20170807 2

<h4>Background</h4>Patient-reported outcomes (PROs) play an increasingly important role as an adjunct to clinical outcome parameters in measuring health-related quality of life (HRQoL). In fact, PROs are already the accepted gold standard for collecting data about patients' subjective perception of their own state of health. Currently, paper-based surveys of PRO still predominate; however, knowledge regarding the feasibility of and barriers to electronic-based PRO (ePRO) acceptance remains limit ...[more]

PMID: 28784595

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Project description:ImportanceElectronic systems that facilitate patient-reported outcome (PRO) surveys for patients with cancer may detect symptoms early and prompt clinicians to intervene.ObjectiveTo evaluate whether electronic symptom monitoring during cancer treatment confers benefits on quality-of-life outcomes.Design, setting, and participantsReport of secondary outcomes from the PRO-TECT (Alliance AFT-39) cluster randomized trial in 52 US community oncology practices randomized to electronic symptom monitoring with PRO surveys or usual care. Between October 2017 and March 2020, 1191 adults being treated for metastatic cancer were enrolled, with last follow-up on May 17, 2021.InterventionsIn the PRO group, participants (n = 593) were asked to complete weekly surveys via an internet-based or automated telephone system for up to 1 year. Severe or worsening symptoms triggered care team alerts. The control group (n = 598) received usual care.Main outcomes and measuresThe 3 prespecified secondary outcomes were physical function, symptom control, and health-related quality of life (HRQOL) at 3 months, measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30; range, 0-100 points; minimum clinically important difference [MCID], 2-7 for physical function; no MCID defined for symptom control or HRQOL). Results on the primary outcome, overall survival, are not yet available.ResultsAmong 52 practices, 1191 patients were included (mean age, 62.2 years; 694 [58.3%] women); 1066 (89.5%) completed 3-month follow-up. Compared with usual care, mean changes on the QLQ-C30 from baseline to 3 months were significantly improved in the PRO group for physical function (PRO, from 74.27 to 75.81 points; control, from 73.54 to 72.61 points; mean difference, 2.47 [95% CI, 0.41-4.53]; P = .02), symptom control (PRO, from 77.67 to 80.03 points; control, from 76.75 to 76.55 points; mean difference, 2.56 [95% CI, 0.95-4.17]; P = .002), and HRQOL (PRO, from 78.11 to 80.03 points; control, from 77.00 to 76.50 points; mean difference, 2.43 [95% CI, 0.90-3.96]; P = .002). Patients in the PRO group had significantly greater odds of experiencing clinically meaningful benefits vs usual care for physical function (7.7% more with improvements of ≥5 points and 6.1% fewer with worsening of ≥5 points; odds ratio [OR], 1.35 [95% CI, 1.08-1.70]; P = .009), symptom control (8.6% and 7.5%, respectively; OR, 1.50 [95% CI, 1.15-1.95]; P = .003), and HRQOL (8.5% and 4.9%, respectively; OR, 1.41 [95% CI, 1.10-1.81]; P = .006).Conclusions and relevanceIn this report of secondary outcomes from a randomized clinical trial of adults receiving cancer treatment, use of weekly electronic PRO surveys to monitor symptoms, compared with usual care, resulted in statistically significant improvements in physical function, symptom control, and HRQOL at 3 months, with mean improvements of approximately 2.5 points on a 0- to 100-point scale. These findings should be interpreted provisionally pending results of the primary outcome of overall survival.Trial registrationClinicalTrials.gov Identifier: NCT03249090.

Project description:IntroductionSymptom-related adverse events associated with perioperative chemotherapy in patients with breast cancer include short-term adverse events such as nausea and vomiting. However, changes in the severity and duration of prolonged symptom-related adverse events have not been fully investigated. We present a protocol of a study that aims to clarify the prevalence of symptom-related adverse events in patients with breast cancer 1 year after neoadjuvant or adjuvant chemotherapy using an electronic patient-reported outcomes (ePRO) system.Methods and analysisThis multicentre prospective observational cohort study will include patients with breast cancer who have received preoperative or postoperative adjuvant chemotherapy. The final injection date of the cytotoxic agent will be the study initiation date. Patients will report every 2 weeks from the initiation date to 12 weeks and every 4 weeks from 12 weeks to 1 year, and they can enter this information into the ePRO system from anywhere. The primary outcome will be the prevalence of symptom-related adverse events according to the ePRO system 1 year after the date of the last injection of the cytotoxic drug used in neoadjuvant or adjuvant chemotherapy for breast cancer. To increase multi-institutional enrolment, two cohorts will be included. Cohort 1 will comprise patients with acquisition of baseline patient information regarding preoperative chemotherapy and presurgery characteristics. Cohort 2 will comprise patients without acquisition of baseline patient information. The target sample size is ≥250 per year.Ethics and disseminationThe study protocol has been approved by the ethics committee at each participating institution. The results will be presented at major national and international conferences and submitted to peer-reviewed journals.Trial statusRegistration was started in October 2021. By August 2022, a total of 132 participants were enrolled. Follow-up will be continued through December 2024.Trial registration numberUMIN000045422.

Project description:ImportanceOften electronic tools are built with English proficient (EP) patients in mind. Cancer patients with limited English proficiency (LEP) experience gaps in care and are at risk for excess toxic effects if they are unable to effectively communicate with their care team.ObjectiveTo evaluate whether electronic patient-reported outcome tools (ePROs) built to improve health outcomes for EP patients might also be acceptable for LEP patients in the context of oral cancer-directed therapies (OCDT).Design, setting, and participantsThis qualitative study was conducted at a single National Cancer Institute-designated comprehensive cancer center. In 2019, English-speaking and Spanish-speaking LEP patients with cancer receiving oral chemotherapies were recruited to participate in a qualitative focus group examining patient attitudes toward ePROs and electronic tools that are used to manage adherence and symptoms related to oral therapies. Six focus groups were held for EP patients and 1 for Spanish-speaking LEP patients. LEP was defined as patients who self-identified as needing an interpreter to navigate the health care system. Data analysis was performed April through June of 2019.ExposuresEnrolled patients participated in a focus group lasting approximately 90 minutes.Main outcomes and measuresThe perspectives of patients with cancer treated with oral chemotherapies on integrating ePROs into their care management.ResultsAmong the 46 participants included in the study, 46 (100%) were White, 10 (22%) were Latinx Spanish-speaking, 43 (93%) were female, and 37 (80%) were aged at least 50 years or older. Among the 6 focus groups with 6 to 8 EP patients (ranging from 6 to 8 participants) and 1 focus group with 10 Spanish-speaking LEP patients, this qualitative study found that EP and LEP patients had different levels of acceptability of using technology and ePRO tools to manage their OCDT. EP patients felt generally positive toward OCDT and were not generally interested in using electronic tools to manage their care. LEP patients generally disliked OCDT and welcomed the use of technology for health management, particularly when addressing gaps in symptom management by their oncology clinicians.Conclusions and relevanceAlthough most electronic interventions target EP patients, these findings reveal the willingness of LEP patients to participate in technology-based interventions. Expanding ePROs to LEP patients may help to manage gaps in communication about treatment and potential adverse events because of the willingness of LEP patients to use ePRO tools to manage their health. This qualitative assessment is a strategic step in determining the resources needed to narrow the digital health gap and extend the value of PROs to the LEP oncology population.

Dataset Information

Electronic-Based Patient-Reported Outcomes: Willingness, Needs, and Barriers in Adjuvant and Metastatic Breast Cancer Patients.

Publications

Electronic-Based Patient-Reported Outcomes: Willingness, Needs, and Barriers in Adjuvant and Metastatic Breast Cancer Patients.

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