Background Relapsed and refractory multiple myeloma (RRMM) is a bone marrow cancer that requires systemic treatment, which often results in severe symptom burden. Recent studies have found that electronic patient-reported outcome (ePRO) interventions implemented in the clinic setting have had positive outcomes for other oncology populations. Evidence of the efficacy of a similar approach is lacking for patients with RRMM. Objective Recent recommendations for digital health interventions call for the publication of descriptions of iterative development processes in order to improve reproducibility and comparability. This study is an implementation pilot aiming to evaluate the acceptability and appropriateness of an ePRO intervention for patients with RRMM and to explore its impact on clinic workflow. Methods A total of 11 patients with RRMM were recruited from the John Theurer Cancer Center in Hackensack, New Jersey. Patients used a mobile app to report on 17 symptoms at 4 sessions, each a week apart. Patients could also report symptoms ad hoc. When reports met predefined thresholds, the clinic was alerted and patients received automated guidance. Study end points were assessed using qualitative and quantitative methods. Results A total of 9 patients (mean age 69.7 years) completed the study. Overall, 83% (30/36) of weekly sessions were completed. Patients found the frequency and time required to complete reporting acceptable. All patients agreed that the app was easy to use and understand. Providers felt the alerts they received required refinement. Patients and providers agreed it would be beneficial for patients to report for longer than 4 weeks. Patients felt that the training they received was adequate but contained too much information for a single session. All patients found the symptoms tracked to be appropriate; providers suggested shortening the list. All patients understood how to use the app for weekly reporting but had confusion about using it ad hoc. Providers felt the ad hoc feature could be removed. Neither patients nor providers viewed the in-app data reports but agreed on their potential value. Patients reported benefitting from symptom reporting through increased awareness of their symptoms. Clinic staff reported that app alerts were too numerous and redundant. They had difficulty responding to alerts within their existing workflow, partially because the data were not integrated into the electronic medical record system. Conclusions Overall, the intervention was found to be acceptable and appropriate for patients with RRMM. Points of friction integrating the intervention into the clinic workflow were identified. Clinic staff provided recommendations for addressing these issues. Once such modifications are implemented, ePRO data from patients with RRMM could be used to inform and improve clinical research and care. This study underlines the importance of an iterative approach to implementation that includes all stakeholders in order to ensure successful adoption.
Objective: Relapsed refractory multiple myeloma (RRMM) is a chronic disease characterized by multiple relapses and lines of therapy. Patients may experience severe symptom burden that impacts treatment adherence. Digital PRO reporting and symptom management in response has shown improved survival and adherence as well as maintenance of health-related quality of life in patients with solid-tumors. Evidence for the efficacy of a similar approach is lacking for patients with RRMM. This implementation study was designed to test the acceptability, appropriateness, and understandability of digital PRO reporting for RRMM patients, and explore its impact on clinic workflow and symptom management. The results are intended to inform and provide guidance for future iterations of digital PRO reporting initiatives for this, or a similar, patient population. Methods: A selective sampling strategy was used to recruit 11 patients with RRMM who had received between 1 and 3 lines of therapy, and were receiving treatment at the John Theurer Cancer Center in Hackensack, NJ. The study period was 3 weeks. Patients reported on the presence, severity, and interference of 17 symptoms from the PRO-CTCAE (Table 1) at 4 scheduled sessions, each a week apart via a digital app. Patients could also report symptoms spontaneously. When symptom reports met pre-defined thresholds, through the app patients received automatically populated symptom self-management guidance, specified by the clinic, and providers were alerted. Reporting details, such as symptom selection and alert criteria, were defined by the clinic team prior to study initiation. Patient experience was assessed through 2 semi-structured interviews conducted approximately 2 weeks apart, a 2-item perceived ease-of-use and understandability measure, and app usage data. Provider experience was assessed through a semi-structured group interview, a 6-item acceptability survey, and abbreviated clinic workflow observation. Results: Nine patients (mean age = 69.7 years) completed the study; 55% were female. Mean time since diagnosis was 10.9 years. Overall, 83% of weekly sessions were completed. All patients rated the app as very easy to use and understandable. All patients found the list of symptoms tracked to be appropriate and the reporting frequency to be acceptable. All patients reported preferring the mobile app over the web portal. Neither patients nor providers reported viewing the symptom reports, which displayed symptom reports over time. Patients reported benefitting from symptom reporting through increased awareness of their symptoms. A total of 33 symptom alerts were generated. Phone calls to the clinic related to reported symptoms increased during the study period. The majority of the providers reported that it was difficult to respond to alerts because of lack of integration with their current system. Providers did not find additional value in receiving symptom alerts from patients between clinic visits because many of those symptoms had previously been addressed through existing communication channels. Patients reported some redundancy in clinic outreach responses to an alert. They perceived that their reported symptoms may have already been addressed, or were not significant enough to warrant a response. No provider discussed symptoms reported via the app at clinic visits. Conclusions: RRMM patients found the app content appropriate, acceptable, and understandable. To increase the value of digital PRO reporting for RRMM symptom management, the clinic team recommended modifications that focus on addressing "treatment fatigue" and controlling patients' long-term disease- and treatment-related symptoms. This could be achieved through the use of longitudinal symptom reports to create more structured, efficient, and meaningful conversations during clinic visits. To increase adoptability, providers felt the symptom alert triggers required revision to make them more clinically meaningful, avoid redundancy, minimize impact on the clinic workflow, and increase integration with existing clinic systems. The results of this implementation study support that digital PRO reporting is acceptable to RRMM patients, and that after implementing modifications, it could be helpful to improve the quality of patient-provider communication, increase adherence, and duration on therapy. Disclosures Biran: Takeda: Consultancy, Honoraria; Bristol Meyers Squibb: Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Research Funding; Merck: Research Funding. Yucel:Amgen Inc.: Employment, Other: Owns Amgen stock, Research Funding. Anthony Kouyaté:Amgen: Employment, Other: Owns Amgen stock. McGovern:Amgen: Consultancy. Schoenthaler:Rip Road: Consultancy. Durling:Amgen: Consultancy. Schutt:Amgen: Consultancy. Panjabi:Amgen Inc.: Employment, Other: Owns Amgen stock, Research Funding.
BACKGROUND Relapsed and refractory multiple myeloma (RRMM) is a bone marrow cancer that requires systemic treatment, which often results in severe symptom burden. Recent studies have found that electronic patient-reported outcome (ePRO) interventions implemented in the clinic setting have had positive outcomes for other oncology populations. Evidence of the efficacy of a similar approach is lacking for patients with RRMM. OBJECTIVE Recent recommendations for digital health interventions call for the publication of descriptions of iterative development processes in order to improve reproducibility and comparability. This study is an implementation pilot aiming to evaluate the acceptability and appropriateness of an ePRO intervention for patients with RRMM and to explore its impact on clinic workflow. METHODS A total of 11 patients with RRMM were recruited from the John Theurer Cancer Center in Hackensack, New Jersey. Patients used a mobile app to report on 17 symptoms at 4 sessions, each a week apart. Patients could also report symptoms ad hoc. When reports met predefined thresholds, the clinic was alerted and patients received automated guidance. Study end points were assessed using qualitative and quantitative methods. RESULTS A total of 9 patients (mean age 69.7 years) completed the study. Overall, 83% (30/36) of weekly sessions were completed. Patients found the frequency and time required to complete reporting acceptable. All patients agreed that the app was easy to use and understand. Providers felt the alerts they received required refinement. Patients and providers agreed it would be beneficial for patients to report for longer than 4 weeks. Patients felt that the training they received was adequate but contained too much information for a single session. All patients found the symptoms tracked to be appropriate; providers suggested shortening the list. All patients understood how to use the app for weekly reporting but had confusion about using it ad hoc. Providers felt the ad hoc feature could be removed. Neither patients nor providers viewed the in-app data reports but agreed on their potential value. Patients reported benefitting from symptom reporting through increased awareness of their symptoms. Clinic staff reported that app alerts were too numerous and redundant. They had difficulty responding to alerts within their existing workflow, partially because the data were not integrated into the electronic medical record system. CONCLUSIONS Overall, the intervention was found to be acceptable and appropriate for patients with RRMM. Points of friction integrating the intervention into the clinic workflow were identified. Clinic staff provided recommendations for addressing these issues. Once such modifications are implemented, ePRO data from patients with RRMM could be used to inform and improve clinical research and care. This study underlines the importance of an iterative approach to implementation that includes all stakeholders in order to ensure successful adoption.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.