This proposal requests continued funding for five years for a randomized trial of breast self examination (BSE), currently underway in 520 factories of the Shanghai Textile Industry Bureau (China). The purpose of the study is to determine whether the regular practice of BSE will reduce mortality from breast cancer. Nearly 300,000 current and retired female workers between the ages of 30 and 64 have been randomly allocated by factory to an intervention or control group. Baseline interview data are being collected from all study participants, and women in the intervention group are receiving initial BSE instruction and reinforcement during the current funding period. Under the renewal, intensive and repeated instruction in BSE will be continued, and additional motivation provided to practice BSE correctly on a regular basis. In addition, compliance with requests to practice BSE and competency in BSE performance will be continuously monitored. All women will be followed for 10 years from initial inclusion in the study for the occurrence of breast cancer and mortality from breast cancer and all other causes using multiple active and passive reporting systems. Initial follow-up procedures have been implemented during the current funding period; additional procedures will be implemented during the renewal. This study has a power of approximately 80% to detect a reduction in breast cancer mortality of about 30%. Interim analyses will be performed during the fifth year of this proposed grant period (mean follow-up of six years, 1.8 million women-years), and the trial will be terminated at that time if a significant reduction in breast cancer mortality is observed; otherwise, a final continuation application will be submitted. This trial is being conducted under virtually optimal conditions and experience to date suggests that successful completion of the study is highly likely. The results will provide an estimate of the upper limit of the beneficial effects that can reasonably be expected of BSE in most situations, and will therefore provide information needed to estimate the potential impact that BSE could have in reducing mortality from breast cancer in the United States.
| Rosenblatt, Karin A; Gao, Dao L; Ray, Roberta M et al. (2009) Oral contraceptives and the risk of all cancers combined and site-specific cancers in Shanghai. Cancer Causes Control 20:27-34 |
| Rosenblatt, Karin A; Gao, Dao L; Ray, Roberta M et al. (2007) Monthly injectable contraceptives and the risk of all cancers combined and site-specific cancers in Shanghai. Contraception 76:40-4 |
| Rosenblatt, Karin A; Gao, Dao L; Ray, Roberta M et al. (2006) Induced abortions and the risk of all cancers combined and site-specific cancers in Shanghai. Cancer Causes Control 17:1275-80 |
| Gao, Dao-li; Thomas, David B; Ray, Roberta M et al. (2005) [Randomized trial of breast self-examination in 266,064 women in Shanghai] Zhonghua Zhong Liu Za Zhi 27:350-4 |
| Frankenfeld, Cara L; Lampe, Johanna W; Shannon, Jackilen et al. (2004) Frequency of soy food consumption and serum isoflavone concentrations among Chinese women in Shanghai. Public Health Nutr 7:765-72 |
| Rosenblatt, K A; Gao, D Li; Ray, R M et al. (2004) Contraceptive methods and induced abortions and their association with the risk of colon cancer in Shanghai, China. Eur J Cancer 40:590-3 |
| Suter, Nicola M; Ray, Roberta M; Hu, Yong Wei et al. (2004) BRCA1 and BRCA2 mutations in women from Shanghai China. Cancer Epidemiol Biomarkers Prev 13:181-9 |
| Ye, Z; Gao, D L; Qin, Q et al. (2002) Breast cancer in relation to induced abortions in a cohort of Chinese women. Br J Cancer 87:977-81 |
| Coriaty Nelson, Zakia; Ray, Roberta M; Gao, Dao Li et al. (2002) Risk factors for fibroadenoma in a cohort of female textile workers in Shanghai, China. Am J Epidemiol 156:599-605 |
| Thomas, David B; Gao, Dao Li; Ray, Roberta M et al. (2002) Randomized trial of breast self-examination in Shanghai: final results. J Natl Cancer Inst 94:1445-57 |
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