Abstract
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.
Highlights
MethodsRESposne to INTegrative breast cancer Treatment (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
Cancer registries usually assess data of conventional treatments and/or patient survival
Study setting and design We developed the RESposne to INTegrative breast cancer Treatment (INTREST) registry as an epidemiological, prospective, multi-center cohort design according to the STROBE and TRIPOD guidelines [33, 34]
Summary
Study setting and design We developed the INTREST registry as an epidemiological, prospective, multi-center cohort design according to the STROBE and TRIPOD guidelines [33, 34]. We assess variables of the study center and the need for and type of conventional treatment procedures including data on the surgical intervention, chemotherapy, radiotherapy, and endocrine therapy as well as whether or not the patient is participating in a clinical trial. All statistical analyses are going to be run with R
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