title: Factors affecting enrollment in a randomized controlled trial for Japanese metastatic breast cancer patients (SELECT BC-FEEL)--a prospective study.
abstract: To accelerate the completion of clinical trials, it is critical to obtain, at high rates, informed consent to participate from patients who are eligible. It is therefore important to know what factors affect the participation rates of eligible patients. Selection of effective chemotherapy for breast cancer and its successor selection of effective chemotherapy for breast cancer-CONFIRM are randomized controlled trials conducted for Japanese patients with chemotherapy-naïve metastatic breast cancer. These trials are intended to compare the current standard chemotherapeutic regimens in the first-line setting, which are taxanes for selection of effective chemotherapy for breast cancer and anthracyclines for selection of effective chemotherapy for breast cancer-CONFIRM, respectively, and an oral regimen of TS-1 in terms of overall survival. We are conducting prospective studies to identify the factors affecting the rates at which informed consent is obtained in selection of effective chemotherapy for breast cancer and breast cancer-CONFIRM. We are using a self-administered questionnaire that we have developed to collect information regarding patients' characteristics and attitude to clinical trials.
authors.affiliation: Department of Breast Oncology, NHO Shikoku Cancer Center, Matsuyama, Ehime sosumi@shikoku-cc.go.jp.
authors.forename: Shozo
authors.initials: S
authors.lastname: Ohsumi
authors.affiliation: Division of Oncology/Hematology, National Cancer Center Hospital East, Kashiwa, Chiba.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Mukai
authors.affiliation: Department of Biostatistics/Epidemiology and Preventive Health Science, School of Health Science and Nursing, University of Tokyo, Tokyo, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D044466:Asian People / Q000706:statistics & numerical data*; D001290:Attitude; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D007258:Informed Consent; D007564:Japan / Q000453:epidemiology; D008875:Middle Aged; D018579:Patient Selection; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D011795:Surveys and Questionnaires
keywords: enrollment; informed consent; metastatic breast cancer; prospective cohort study