Systematic screening as a tool for individualized rehabilitation following primary breast cancer treatment: study protocol for the ReScreen randomized controlled trial

U Olsson Möller, L Rydén, M Malmström, U Olsson Möller, L Rydén, M Malmström

Abstract

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.

Keywords: Breast cancer; Individualization; RCT; Rehabilitation; Screening; Sickness absence; Symptom distress.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Description phase I-III. BC = breast cancer, HCP = Health care professionals, RCT = randomized controlled trial, SR = Systematic review
Fig. 2
Fig. 2
SPIRIT flow diagram of the ReScreen study
Fig. 3
Fig. 3
Overview of allocation and data collection points
Fig. 4
Fig. 4
Example of the decision support tool focusing on problem area fatigue

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