PRO B: evaluating the effect of an alarm-based patient-reported outcome monitoring compared with usual care in metastatic breast cancer patients—study protocol for a randomised controlled trial

Karsten, Maria Margarete; Kühn, Friedrich; Pross, Therese; Blohmer, Jens-Uwe; Hage, Anna Maria; Fischer, Felix; Rose, Matthias; Grittner, Ulrike; Gebert, Pimrapat; Ferencz, Julia; Pauler, Luis; Breidenbach, Clara; Kowalski, Christoph

doi:10.1186/s13063-021-05642-6

Cited by 15 publications

(19 citation statements)

References 24 publications

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“…Self-monitoring of the symptoms further provides the opportunity to adjust the treatment in communication with healthcare professionals . Therefore, some apps directly transmit the results of symptom reports to the patients oncologist or physician [27 ▪▪ ,29 ▪ ,33 ▪ ,34 ▪▪ ,35]. Other apps have integrated important links or phone numbers to healthcare providers [30] or allow patients to connect with other cancer survivors [20].…”

Section: Resultsmentioning

confidence: 99%

Content features and its implementation in novel app-based psycho-oncological interventions for cancer survivors: a narrative review

Springer¹,

Mehnert‐Theuerkauf²

2022

Current Opinion in Oncology

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Purpose of reviewThe interest in and availability of app-based psycho-oncological interventions for cancer survivors has grown rapidly. In this narrative review, we therefore aim to provide an overview of the psychological content features included in psycho-oncological apps and how the content is implemented in the apps.Recent findingsA total of 19 studies (six randomized controlled trials, six studies with prepost design, five study protocols and two app developments), all published in the last 18 months (July 2020 to December 2021), were analyzed in terms of the described app-based interventions and their psycho-oncological content. Apps for cancer survivors are conducted for a variety of different diagnoses and often target a specific patient population, for example patients with a specific therapy. The most frequent content features are psychoeducation, self-monitoring of symptoms, and some sort of exercise or relaxation program. Depending on the app's purpose, some offer specific content, such as decision aids, medication schedules or modules to improve coping strategies. Most apps combine informative and interactive elements.SummaryPsycho-oncological apps for cancer survivors target many relevant psychological problem areas and aim to improve patient empowerment. Available mHealth interventions can therefore be seen as a good complement for cancer care and also offer the possibility to improve patient involvement.

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Section: Resultsmentioning

confidence: 99%

Content features and its implementation in novel app-based psycho-oncological interventions for cancer survivors: a narrative review

Springer¹,

Mehnert‐Theuerkauf²

2022

Current Opinion in Oncology

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“…Of the 91 studies, 78 (86%) [8,9,12,16, were research articles, whereas 13 (14%) [119][120][121][122][123][124][125][126][127][128][129][130][131] Owing to their heterogeneous nature, the selected articles had different study durations, ranging from 2 weeks for small-scale trials to up to 2 years for larger-scale RCTs. The median sample size of the study participants was 51, ranging from a minimum of 5 to a maximum of 4475 patients.…”

Section: Overview Of Selected Studiesmentioning

confidence: 99%

“…mHealth users can be patients, clinicians, a broader pool of health care professionals (HCPs), or different combinations of users. Most commonly, apps are designed for both patients and clinicians (42/73, 58%)[12,16,[48][49][50][51][52][53][54][55]58,59,61,63,66,67,69,75,77,[84][85][86]89,[91][92][93][94]96,98,100,101,[104][105][106]108,110,[112][113][114][115][116]119,120,[122][123][124][125][127][128][129]…”

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confidence: 99%

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Evaluating Barriers and Facilitators to the Uptake of mHealth Apps in Cancer Care Using the Consolidated Framework for Implementation Research: Scoping Literature Review

Ardito¹,

Golubev²,

Ciani³

et al. 2023

JMIR Cancer

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Background Mobile health (mHealth) solutions have proven to be effective in a wide range of patient outcomes and have proliferated over time. However, a persistent challenge of digital health technologies, including mHealth, is that they are characterized by early dropouts in clinical practice and struggle to be used outside experimental settings or on larger scales. Objective This study aimed to explore barriers and enablers to the uptake of mHealth solutions used by patients with cancer undergoing treatment, using a theory-guided implementation science model, that is, the Consolidated Framework for Implementation Research (CFIR). Methods A scoping literature review was conducted using PubMed (MEDLINE), Web of Science, and ScienceDirect databases in March 2022. We selected studies that analyzed the development, evaluation, and implementation of mHealth solutions for patients with cancer that were used in addition to the standard of care. Only empirical designs (eg, randomized controlled trials, observational studies, and qualitative studies) were considered. First, information on the study characteristics, patient population, app functionalities, and study outcomes was extracted. Then, the CFIR model was used as a practical tool to guide data collection and interpretation of evidence on mHealth uptake. Results Overall, 91 papers were included in the data synthesis. The selected records were mostly randomized controlled trials (26/91, 29%) and single-arm, noncomparative studies (52/91, 57%). Most of the apps (42/73, 58%) were designed for both patients and clinicians and could be used to support any type of cancer (29/73, 40%) and a range of oncological treatments. Following the CFIR scheme (intervention, outer setting, inner setting, individuals, process), multistakeholder co-design, codevelopment, and testing of mHealth interventions were identified as key enablers for later uptake. A variety of external drivers emerged, although the most relevant outer incentive fostering mHealth use was addressing patient needs. Among organizational factors likely to influence technology uptake, interoperability was the most prominent, whereas other providers’ dimensions such as managerial attitudes or organizational culture were not systematically discussed. Technology-related impediments that could hamper the use of mHealth at the individual level were considered least often. Conclusions The hype surrounding mHealth in cancer care is hindered by several factors that can affect its use in real world and nonexperimental settings. Compared with the growing evidence on mHealth efficacy, knowledge to inform the uptake of mHealth solutions in clinical cancer care is still scarce. Although some of our findings are supported by previous implementation research, our analysis elaborates on the distinguishing features of mHealth apps and provides an integrated perspective on the factors that should be accounted for implementation efforts. Future syntheses should liaise these dimensions with strategies observed in successful implementation initiatives.

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“…While designing the PRO B study [ 11 ] which aims to evaluate the effects of an app-based PRO-monitoring with alerts on metastatic breast cancer patients’ fatigue levels and QoL, we modified an existing digital symptom monitoring tool specifically for the project. The adapted system measures ePROs weekly using an app, then graphically displays the results for clinicians in a web tool and generates alerts in the case of deteriorating ePROs.…”

Section: Introductionmentioning

confidence: 99%

Examining the Feasibility of an Application-Based Patient-Reported Outcome Monitoring for Breast Cancer Patients: A Pretest for the PRO B Study

Hage

Gebert

Kühn

et al. 2022

IJERPH

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In preparation for the PRO B study which aims to examine the effects of an app-based intensified patient-reported outcome (PRO) monitoring for metastatic breast cancer patients, prior assessment of its feasibility was carried out. Sixteen breast cancer patients visiting the breast cancer unit at Charité were recruited and downloaded an app connected to an ePRO system. They received electronic questionnaires on two occasions (baseline and the following week) and were subsequently contacted for a semi-structured phone interview for evaluation. Eleven participants answered at least one questionnaire. Some participants did not receive any or only a part of the questionnaires due to technical problems with the app. Participants who completed the evaluation questionnaire (n = 6) were overall satisfied with the weekly PRO questionnaire. All interviewed (n = 11) participants thought it was feasible to answer the PRO questionnaires on a weekly basis for one year, as planned in the PRO B study. The pretest revealed a need for major technical adjustments to the app because push notifications about the receipt of new questionnaires were not displayed on some smartphone models. Due to the low number of participants, generalization of the findings is limited to our specific context and study. Nevertheless, we could conclude that if technical aspects of the app were improved, the PRO B study could be implemented as planned. The ePRO questionnaire was considered feasible and adequate from the patients’ perspectives.

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PRO B: evaluating the effect of an alarm-based patient-reported outcome monitoring compared with usual care in metastatic breast cancer patients—study protocol for a randomised controlled trial

Cited by 15 publications

References 24 publications

Content features and its implementation in novel app-based psycho-oncological interventions for cancer survivors: a narrative review

Content features and its implementation in novel app-based psycho-oncological interventions for cancer survivors: a narrative review

Evaluating Barriers and Facilitators to the Uptake of mHealth Apps in Cancer Care Using the Consolidated Framework for Implementation Research: Scoping Literature Review

Examining the Feasibility of an Application-Based Patient-Reported Outcome Monitoring for Breast Cancer Patients: A Pretest for the PRO B Study

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