The INTREST registry: protocol of a multicenter prospective cohort study of predictors of women’s response to integrative breast cancer treatment

Heidemarie Haller; Petra Voiß; Holger Cramer; Anna Paul; Mattea Reinisch; Sebastian Appelbaum; Gustav Dobos; Georg Sauer; Sherko Kümmel; Thomas Ostermann

doi:10.1186/s12885-021-08468-2

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The INTREST registry: protocol of a multicenter prospective cohort study of predictors of women’s response to integrative breast cancer treatment

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The INTREST registry: protocol of a multicenter prospective cohort study of predictors of women’s response to integrative breast cancer treatment

Heidemarie Haller, Petra Voiß, Holger Cramer, Anna Paul, Mattea Reinisch, Sebastian Appelbaum, Gustav Dobos, Georg Sauer, Sherko Kümmel and Thomas Ostermann

BMC cancer, Vol.21, pp.1-9

23/06/2021

DOI: https://doi.org/10.1186/s12885-021-08468-2

PMID: 34162339

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Abstract

Breast Cancer

Complementary medicine

Integrative Cancer treatment

Predictors

Study Protocol

Treatment response

Background Cancer registries usually assess data of conventional treatments and/or patient survival. Beyond that, little is known about the influence of other predictors of treatment response related to the use of complementary therapies (CM) and lifestyle factors affecting patients’ quality and quantity of life. Methods INTREST is a prospective cohort study collecting register data at multiple German certified cancer centers, which provide individualized, integrative, in- and outpatient breast cancer care. Patient-reported outcomes and clinical cancer data of anticipated N = 715 women with pTNM stage I-III breast cancer are collected using standardized case report forms at the time of diagnosis, after completing neo−/adjuvant chemotherapy, after completing adjuvant therapy (with the exception of endocrine therapy) as well as 1, 2, 5, and 10 years after baseline. Endpoints for multivariable prediction models are quality of life, fatigue, treatment adherence, and progression-based outcomes/survival. Predictors include the study center, sociodemographic characteristics, histologic cancer and comorbidity data, performance status, stress perception, depression, anxiety, sleep quality, spirituality, social support, physical activity, diet behavior, type of conventional treatments, use of and belief in CM treatments, and participation in a clinical trial. Safety is recorded following the Common Terminology Criteria for Adverse Events. Discussion This trial is currently recruiting participants. Future analyses will allow to identify predictors of short- and long-term response to integrative breast cancer treatment in women, which, in turn, may improve cancer care as well as quality and quantity of life with cancer.

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Title: The INTREST registry: protocol of a multicenter prospective cohort study of predictors of women’s response to integrative breast cancer treatment
Creators: Heidemarie Haller - University of Duisburg-Essen
Petra Voiß - University of Duisburg-Essen
Holger Cramer - University of Duisburg-Essen
Anna Paul - University of Duisburg-Essen
Mattea Reinisch - Kliniken Essen-Mitte
Sebastian Appelbaum - Witten/Herdecke University
Gustav Dobos - University of Duisburg-Essen
Georg Sauer - Robert Bosch Hospital
Sherko Kümmel - Kliniken Essen-Mitte
Thomas Ostermann - Witten/Herdecke University
Publication Details: BMC cancer, Vol.21, pp.1-9
Publisher: BioMed Central
Grant note: KKF-2016-3 / ;
Identifiers: 991013035757302368
Copyright: © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Academic Unit: National Centre for Naturopathic Medicine
Language: English
Resource Type: Journal article

The INTREST registry: protocol of a multicenter prospective cohort study of predictors of women’s response to integrative breast cancer treatment

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