Systematic screening as a tool for individualized rehabilitation following primary breast cancer treatment : Study protocol for the ReScreen randomized controlled trial
Olsson Möller, U. LU ; Rydén, L. LU
and Malmström, M.
LU
(2020)
In BMC Cancer
20(1).
- 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.... (More)
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.
(Less)
- author
- Olsson Möller, U.
LU
; Rydén, L.
LU
and Malmström, M.
LU
- organization
- publishing date
- 2020-05-29
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Breast cancer, Individualization, RCT, Rehabilitation, Screening, Sickness absence, Symptom distress
- in
- BMC Cancer
- volume
- 20
- issue
- 1
- article number
- 484
- publisher
- BioMed Central (BMC)
- external identifiers
-
- pmid:32471390
- scopus:85085592211
- ISSN
- 1471-2407
- DOI
- 10.1186/s12885-020-06815-3
- language
- English
- LU publication?
- yes
- id
- 539a510d-3828-44e6-8882-5944fccd5058
- date added to LUP
- 2020-06-15 17:05:26
- date last changed
- 2024-04-03 08:58:38
@article{539a510d-3828-44e6-8882-5944fccd5058,
abstract = {{<p>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. </p>}},
author = {{Olsson Möller, U. and Rydén, L. and Malmström, M.}},
issn = {{1471-2407}},
keywords = {{Breast cancer; Individualization; RCT; Rehabilitation; Screening; Sickness absence; Symptom distress}},
language = {{eng}},
month = {{05}},
number = {{1}},
publisher = {{BioMed Central (BMC)}},
series = {{BMC Cancer}},
title = {{Systematic screening as a tool for individualized rehabilitation following primary breast cancer treatment : Study protocol for the ReScreen randomized controlled trial}},
url = {{http://dx.doi.org/10.1186/s12885-020-06815-3}},
doi = {{10.1186/s12885-020-06815-3}},
volume = {{20}},
year = {{2020}},
}