ArticleTrials2021
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.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed.
- Providers' perspectives on implementing alert-based patient-reported outcome monitoring for stage IV breast cancer.Journal of patient-reported outcomes · 2026Trial
- Quantitative assessment of visual designs for communicating patient-reported outcomes in breast cancer care to patients.Journal of patient-reported outcomes · 2025Trial
- Trial
- Translating the EORTC CAT core and the QLQ-C30 to the EQ-5D-5L in patients with metastatic breast cancer: A comparison of direct and indirect mapping algorithms.The European journal of health economics : HEPAC : health economics in prevention and care · 2026Article
- From participatory design to clinical routine: new concepts for visualizing patient-reported outcomes in breast cancer care.Journal of patient-reported outcomes · 2026Article
- Lower extremity lymphedema in patients with gynecologic cancer: Validation of the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) in German language and investigation of lymphedema real-world treatment.Archives of gynecology and obstetrics · 2025Observational
- Systematic development of a patient-reported ONCOlogical-ROUTinE-Screening (ONCO-ROUTES) procedure at the University Cancer Center Regensburg.Journal of cancer research and clinical oncology · 2024Article
- Longitudinal assessment of real-world patient adherence: a 12-month electronic patient-reported outcomes follow-up of women with early breast cancer undergoing treatment.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024Article
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- Article
- Article
- Examining the Feasibility of an Application-Based Patient-Reported Outcome Monitoring for Breast Cancer Patients: A Pretest for the PRO B Study.International journal of environmental research and public health · 2022Article
- Review
Corrections and comments
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Authors and funding
14 authors.
Funding
Abstract
backgroundDespite the progress of research and treatment for breast cancer, still up to 30% of the patients afflicted will develop distant disease. Elongation of survival and maintaining the quality of life (QoL) become pivotal issues guiding the treatment decisions. One possible approach to optimise survival and QoL is the use of patient-reported outcomes (PROs) to timely identify acute disease-related burden. We present the protocol of a trial that investigates the effect of real-time PRO data captured with electronic mobile devices on QoL in female breast cancer patients with metastatic disease.
methodsThis study is a randomised, controlled trial with 1:1 randomisation between two arms. A total of 1000 patients will be recruited in 40 selected breast cancer centres. Patients in the intervention arm receive a weekly request via an app to complete the PRO survey. Symptoms will be assessed by study-specific optimised short forms based on the EORTC QLQ-C30 domains using items from the EORTC CAT item banks. In case of deteriorating PRO scores, an alarm is sent to the treating study centre as well as to the PRO B study office. Following the alarm, the treating breast cancer centre is required to contact the patient to inquire about the reported symptoms and to intervene, if necessary. The intervention is not specified and depends on the clinical need determined by the treating physician. Patients in the control arm are prompted by the app every 3 months to participate in the PRO survey, but their response will not trigger an alarm. The primary outcome is the fatigue level 6 months after enrolment. Secondary endpoints include among others hospitalisations, use of rescue services and overall QoL. DISCUSSION: Within the PRO B intervention group, we expect lower fatigue levels 6 months after intervention start, higher levels of QoL, less unplanned hospitalisations and less emergency room visits compared to controls. In case of positive results, our approach would allow a fast and easy transfer into clinical practice due to the use of the already nationwide existing IT infrastructure of the German Cancer Society and the independent certification institute OnkoZert.
trial registrationDRKS (German Clinical Trials Register) DRKS00024015 . Registered on 15 February 2021.
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