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Systematic screening as a tool for individualized rehabilitation following primary breast cancer treatment: study protocol for the ReScreen randomized controlled trial.
Kristianstad University, Faculty of Health Science, Avdelningen för sjuksköterskeutbildningarna och integrerad hälsovetenskap. Kristianstad University, Faculty of Health Science, Forskningsmiljön Människa - Hälsa - Samhälle (MHS). Kristianstad University, Faculty of Health Science, Research Environment PRO-CARE, Patient Reported Outcomes - Clinical Assessment Research and Education.ORCID iD: 0000-0002-6879-9563
Lunds universitet.
Lunds universitet.
2020 (English)In: BMC Cancer, E-ISSN 1471-2407, Vol. 20, no 1Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: It is well known that women suffer from negative consequences following breast cancer (BC) treatment and that their largely varying needs for rehabilitation are often unmet. Up to 43% of these women are at risk of developing chronic distress requiring complex interventions; however, how to early identify and meet these women's needs is unknown, leaving them with suboptimal chances of rehabilitation. The aim of the ReScreen study is to develop a model for and evaluate the effect of screening-based, individualized rehabilitation following primary BC treatment.

METHODS: The ReScreen study is designed as a complex intervention. Women with newly diagnosed BC are consecutively included in a three-armed randomized controlled trial. At inclusion, patients score their distress level on the Distress Thermometer (scale of 0-10) aiming to identify patients with extended rehabilitation needs. Patients scoring ≥5 are randomized to the intervention or control group while patients scoring ≤4 are followed longitudinally as an observational group. Patients in the intervention group, in conjunction with a dedicated research nurse, create an individualized rehabilitation plan based on an evidence-based decision support tool that was developed to create a solid base for the intervention. The research nurse will act as a continuous health care contact and be responsible for proactively and systematically evaluating patients' needs to ensure that potential new problems or changed rehabilitation needs are identified throughout the 1-year follow-up period. The intervention will be evaluated through self-reported data focusing on physical and psychological outcomes as well as evaluation of satisfaction with care at baseline, 2 weeks and 3, 6, 9 and 12 months. Evaluation will also include health economic aspects based on register data and patients' and relatives' experiences of the rehabilitation process. In addition, optimal cut-off levels for distress as an indicator for extended rehabilitation needs will be investigated.

DISCUSSION: This study will provide important knowledge related to effectiveness of screening-based identification of rehabilitation needs and standardized evidence-based, individualized rehabilitation after primary BC treatment. With a complex intervention design, this study has the potential to form a comprehensive knowledge base which includes tools and guidelines for implementation into clinical practice.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03434717. Registered February 15, 2018.

Place, publisher, year, edition, pages
2020. Vol. 20, no 1
Keywords [en]
Breast cancer, Individualization, RCT, Rehabilitation, Screening, Sickness absence, Symptom distress
National Category
Health Sciences
Identifiers
URN: urn:nbn:se:hkr:diva-20623DOI: 10.1186/s12885-020-06815-3ISI: 000537960500002PubMedID: 32471390OAI: oai:DiVA.org:hkr-20623DiVA, id: diva2:1434125
Available from: 2020-06-02 Created: 2020-06-02 Last updated: 2024-07-04Bibliographically approved

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Avdelningen för sjuksköterskeutbildningarna och integrerad hälsovetenskapForskningsmiljön Människa - Hälsa - Samhälle (MHS)Research Environment PRO-CARE, Patient Reported Outcomes - Clinical Assessment Research and Education
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