Abstract
BackgroundIt 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.MethodsThe 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.DiscussionThis 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 registrationClinicalTrials.gov NCT03434717. Registered February 15, 2018.
Highlights
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
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
The content of the decision support tool is described in detail under “Intervention group”
Summary
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. Despite extensive evidence of the positive effects of cancer rehabilitation, patients with breast cancer (BC) still suffer from unmet rehabilitation needs [1]. These patients are often affected physically as well as mentally but the level of constraints such as fatigue [2] or shoulder pain [3] and emotional distress [4] differs greatly between individuals, indicating a need for individualized rehabilitation. Decreased mortality rates have been reported [7, 8] and the 5- and 10year survival rate in Sweden is as high as 92 and 86% respectively [6] This means that a large number of women survive their cancer and may be in need of support and rehabilitation. Despite extensive knowledge about BC patients’ heterogeneous problems and needs, these women are often offered inadequate and nonindividualized support and rehabilitation, leaving them with suboptimal chances of rehabilitation [1]
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