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

Autor: Marlene Malmström, U. Olsson Möller, Lisa Rydén
Rok vydání: 2020
Předmět:
Cancer Research
medicine.medical_treatment
Pilot Projects
law.invention
Study Protocol
Breast cancer
0302 clinical medicine
Cancer Survivors
Randomized controlled trial
law
Health care
Mass Screening
030212 general & internal medicine
Randomized Controlled Trials as Topic
Rehabilitation
Middle Aged
Hälsovetenskaper
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Distress
Oncology
Symptom distress
030220 oncology & carcinogenesis
Screening
Female
RCT
Adult
medicine.medical_specialty
Breast Neoplasms
lcsh:RC254-282
Sickness absence
03 medical and health sciences
Intervention (counseling)
Health Sciences
Genetics
medicine
Humans
Individualization
Protocol (science)
business.industry
medicine.disease
Early Diagnosis
Quality of Life
Physical therapy
Feasibility Studies
Observational study
business
Stress
Psychological
Follow-Up Studies
Zdroj: BMC Cancer
BMC Cancer, Vol 20, Iss 1, Pp 1-11 (2020)
ISSN: 1471-2407
DOI: 10.1186/s12885-020-06815-3
Popis: 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.
Databáze: OpenAIRE
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