Community-based clinical trial among Yerevan women to determine the effect of a breast cancer intervention program

Abstract

Breast cancer is the most commonly diagnosed cancer among women all over the world. It is the leading cause of death from cancers among Armenian women. Growth in the rate of incidence of breast cancer in the country is observed among younger women. The rate of death increased from 9.4 (per 100,000) in 1994 to 11.8 in 1998. It is believed that the mortality rate actually is higher because the overall population figures are lower that those officially reported. This increase is primarily due to a lack of access to health care services, fewer screening opportunities, and delays in seeking treatment. The screening rate is extremely low despite existing services. To increase screening utilization, it is necessary to identify factors associated with women’s decisions to have mammogram/breast self-examination (BSE)/clinical breast examination (CBE). This is a grant proposal designed to conduct a community-based, crossover clinical trial among 400 women from ages 35 to 65 years to determine breast cancer related knowledge levels, perceived mammography/BSE/CBE benefits and barriers, and the stage of adoption of screening practices as well as to conduct and evaluate breast cancer education classes among these women. Goals of the education program: Increase of breast cancer related knowledge, woman-to-woman promotion of screening, and actual participation in screening. Objectives: This study will assess whether a breast cancer education program results in favorable, replicable, and sustained outcomes. Principal outcome of the study is the use of screening methods, and secondary outcomes are the stage of mammography adoption and talking with friends/relatives about breast cancer and breast cancer screening methods. 3 Intervention: Six education classes will meet three times a week for two-hours during a 2-week period. After education classes; consultations are available for two-month period. Study population: Women between ages 35 to 65 years. The duration of the program is 3 years. Methods: After baseline interviews, Group I will receive the education program, and Group II will act as the comparison group. Year 2 will be the crossover year in which Group II women will receive the program. Year 2 survey data from the Group I will be compared to year 3 data from group II to determine whether Group I findings could be replicated in year 3. Statistical analysis: Chi square and t-test with 95% CI will be used to examine baseline characteristics and outcomes of the cohort of women interviewed at all three data collection periods. To model positive, negative or no change, ordinal logistic regression analysis will be used. To determine whether the subjects' responses to the health belief model scale items are associated with staging, a multiple logistic regression analysis will be performed.