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

被引:3
作者
Haller, Heidemarie [1 ]
Voiss, Petra [1 ,2 ]
Cramer, Holger [1 ]
Paul, Anna [1 ]
Reinisch, Mattea [2 ]
Appelbaum, Sebastian [3 ]
Dobos, Gustav [1 ]
Sauer, Georg [4 ]
Kummel, Sherko [2 ]
Ostermann, Thomas [3 ]
机构
[1] Univ Duisburg Essen, Evang Kliniken Essen Mitte, Fac Med, Dept Internal & Integrat Med, Deimelsberg 34a, D-45276 Essen, Germany
[2] Evang Kliniken Essen Mitte, Breast Unit, Essen, Germany
[3] Witten Herdecke Univ, Chair Res Methodol & Stat Psychol, Dept Psychol, Witten, Germany
[4] Robert Bosch Krankenhaus, Dept Gynecol & Obstet, Stuttgart, Germany
关键词
Breast Cancer; Predictors; Treatment response; Integrative Cancer treatment; Complementary medicine; QUALITY-OF-LIFE; MINIMALLY IMPORTANT DIFFERENCES; FUNCTIONAL ASSESSMENT; ALTERNATIVE MEDICINE; SHORT-FORM; SLEEP DISTURBANCE; END-POINTS; COMPLEMENTARY; THERAPY; QUESTIONNAIRE;
D O I
10.1186/s12885-021-08468-2
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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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页数:9
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