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

BMC Cancer

Mattea Reinisch¹  Sherko Kümmel¹  Georg Sauer²  Holger Cramer³  Gustav Dobos³  Heidemarie Haller³  Anna Paul³  Petra Voiß⁴  Thomas Ostermann⁵  Sebastian Appelbaum⁵ 

[1] Breast Unit, Evang. Kliniken Essen-Mitte, Essen, Germany;Department of Gynecology and Obstetrics, Robert-Bosch-Hospital, Stuttgart, Germany;Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34a, 45276, Essen, Germany;Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34a, 45276, Essen, Germany;Breast Unit, Evang. Kliniken Essen-Mitte, Essen, Germany;Department of Psychology, Chair of Research Methodology and Statistics in Psychology, Witten / Herdecke University, Witten, Germany;

关键词: Breast Cancer;    Predictors;    Treatment response;    Integrative Cancer treatment;    Complementary medicine;   

DOI  :  10.1186/s12885-021-08468-2

来源: Springer

【 摘 要 】

BackgroundCancer 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.MethodsINTREST 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.DiscussionThis 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.Trial registrationGerman Clinical Trial Register DRKS00014852. Retrospectively registered at July 4th, 2018.

【 授权许可】

CC BY