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Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial

BACKGROUND: Adjuvant endocrine therapy can improve disease-free survival and time before recurrence in breast cancer patients. However, it is associated with considerable side effects that negatively affect patients’ quality of life and cause non-adherence. The recently demonstrated effect of indivi...

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Autores principales: von Blanckenburg, Pia, Schuricht, Franziska, Albert, Ute-Susann, Rief, Winfried, Nestoriuc, Yvonne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3848828/
https://www.ncbi.nlm.nih.gov/pubmed/24047450
http://dx.doi.org/10.1186/1471-2407-13-426
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author von Blanckenburg, Pia
Schuricht, Franziska
Albert, Ute-Susann
Rief, Winfried
Nestoriuc, Yvonne
author_facet von Blanckenburg, Pia
Schuricht, Franziska
Albert, Ute-Susann
Rief, Winfried
Nestoriuc, Yvonne
author_sort von Blanckenburg, Pia
collection PubMed
description BACKGROUND: Adjuvant endocrine therapy can improve disease-free survival and time before recurrence in breast cancer patients. However, it is associated with considerable side effects that negatively affect patients’ quality of life and cause non-adherence. The recently demonstrated effect of individual expectations on side-effect development (nocebo effect) suggests that psychological factors play a role in the prevention of side effects. The aim of this study is to evaluate cognitive-behavioral side-effect prevention training (SEPT) for breast cancer patients. This article describes the study protocol and applied research methods. METHODS/DESIGN: In a randomized controlled trial, 184 female breast cancer patients are assigned to receive either SEPT, standard medical care or a manualized supportive therapy at the start of adjuvant endocrine treatment. SEPT consists of three sessions of cognitive-behavioral training including psychoeducation to provide a realistic view of endocrine therapy, imagination-training to integrate positive aspects of medication into daily life, and side-effect management to enhance expectations about coping ability. Side effects three months after the start of endocrine therapy serve as primary outcomes. Secondary outcomes include quality of life, coping ability and patients’ medication adherence. Patients’ expectations (i.e., expectations about side effects, coping ability, treatment and illness) are analyzed as mediators. DISCUSSION: The optimization of expectations might be a potential pathway in health care to improve patients’ quality of life during long-term medication intake. The results will provide implications for a possible integration of evidence-based prevention training into clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov, (NCT01741883).
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spelling pubmed-38488282013-12-04 Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial von Blanckenburg, Pia Schuricht, Franziska Albert, Ute-Susann Rief, Winfried Nestoriuc, Yvonne BMC Cancer Study Protocol BACKGROUND: Adjuvant endocrine therapy can improve disease-free survival and time before recurrence in breast cancer patients. However, it is associated with considerable side effects that negatively affect patients’ quality of life and cause non-adherence. The recently demonstrated effect of individual expectations on side-effect development (nocebo effect) suggests that psychological factors play a role in the prevention of side effects. The aim of this study is to evaluate cognitive-behavioral side-effect prevention training (SEPT) for breast cancer patients. This article describes the study protocol and applied research methods. METHODS/DESIGN: In a randomized controlled trial, 184 female breast cancer patients are assigned to receive either SEPT, standard medical care or a manualized supportive therapy at the start of adjuvant endocrine treatment. SEPT consists of three sessions of cognitive-behavioral training including psychoeducation to provide a realistic view of endocrine therapy, imagination-training to integrate positive aspects of medication into daily life, and side-effect management to enhance expectations about coping ability. Side effects three months after the start of endocrine therapy serve as primary outcomes. Secondary outcomes include quality of life, coping ability and patients’ medication adherence. Patients’ expectations (i.e., expectations about side effects, coping ability, treatment and illness) are analyzed as mediators. DISCUSSION: The optimization of expectations might be a potential pathway in health care to improve patients’ quality of life during long-term medication intake. The results will provide implications for a possible integration of evidence-based prevention training into clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov, (NCT01741883). BioMed Central 2013-09-18 /pmc/articles/PMC3848828/ /pubmed/24047450 http://dx.doi.org/10.1186/1471-2407-13-426 Text en Copyright © 2013 von Blanckenburg et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
von Blanckenburg, Pia
Schuricht, Franziska
Albert, Ute-Susann
Rief, Winfried
Nestoriuc, Yvonne
Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial
title Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial
title_full Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial
title_fullStr Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial
title_full_unstemmed Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial
title_short Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial
title_sort optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3848828/
https://www.ncbi.nlm.nih.gov/pubmed/24047450
http://dx.doi.org/10.1186/1471-2407-13-426
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