Increasing Colorectal and Breast Cancer Screening in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,196
- 主要终点
- Primary Outcome:differences in stage of adoption (precontemplation, contemplation, action) when controlling for adherence to BC screening at baseline, among women who are randomized to 1) usual care; 2) a TIWeb; 3) a CSC, and 4) a TIWeb plus a CSC.
研究概览
简要总结
This study compares the efficacy (adherence and stage) of four interventions to promote colorectal (CRC) and breast cancer (BC) screenings among women ages 50 to 75. They are:
- usual care;
- a TIWeb (tailored intervention Website)
- a CSC (cancer screening call) and
- TIWeb + a CSC. This study also compares the cost-effectiveness of the 4 interventions to promote CRC and BC screening among women ages 50 to 75.
详细描述
This study addresses innovative approaches to increase adherence to screening tests for colorectal and breast cancer - two cancers that have the greatest impact on female cancer mortality in the United States.The cancer burden in women could be significantly reduced by increasing participation in recommended screening for colorectal cancer (CRC) and breast cancer (BC) in all eligible women. This research tests intervention to simultaneously increase both CRC and BC screening using behavior change strategies, and also estimates the efficacy and cost-effectiveness of the interventions. Two groups of women, Group A (adherent to BC screening guidelines, but NOT to CRC screening guidelines) and Group B (non-adherent to BC & CRC guidelines) are randomized to 1. Usual Care, 2. TIWeb, 3. CSC and 4. TIWeb +CSC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •a patient of any of the participating physicians
- •not having had a fecal occult blood test (fobt) in the last 12 months
- •not having had a fecal immunochemical test (fit) in the past 15 months
- •not having had sigmoidoscopy more than 5 years ago
- •not having had a colonoscopy more than 10 years ago
- •have high-speed internet access
- •Exclusion Criteria
- •a personal history of colorectal cancer
- •a personal history of breast cancer
- •a personal history of colorectal polyps
- •a personal history of inflammatory bowel disease
- •having any medical conditions that would prohibit a mammogram or CRC screening
- •have already had CRC screening
排除标准
- 未提供
研究组 & 干预措施
Usual Care (UC)
The usual care group received usual care that varies dependent upon the practice setting.
干预措施: UC (Behavioral)
TIWeb
TIWeb (Tailored Web Intervention) program is interactive and tailored to the participant's individual beliefs and demographics. Individuals receiving the TIWeb will be given information that allows them to call and receive an FOBT kit in the mail or schedule an appropriate CRC test and/or mammogram.
干预措施: TIWeb (Behavioral)
Cancer Screening Call (CSC)
CSC - a telephone counseling call during which the participant is given the opportunity to complete CRC screening (FOBT or a colonoscopy) and/or mammography screening.The CSC included tailored counseling as well as the ability to schedule BC and CRC screening tests.
干预措施: CSC (Behavioral)
TIWeb+CSC
TIWeb + CSC ((Tailored web intervetion+Cancer screening) group receive a mailed TIWeb, which is followed in four weeks by a CSC with the same opportunity to receive FOBT kits or schedule a colonoscopy and/or mammogram. The nurse counselor, knowing the participant is a good candidate for screening tests, will be trained to schedule CRC or BC screening appointments or to mail FOBT kits to individuals in the intervention groups even if they have not had a recent clinic visit.
干预措施: TIWeb+CSC (Behavioral)
结局指标
主要结局
Primary Outcome:differences in stage of adoption (precontemplation, contemplation, action) when controlling for adherence to BC screening at baseline, among women who are randomized to 1) usual care; 2) a TIWeb; 3) a CSC, and 4) a TIWeb plus a CSC.
时间窗: 6 months from the baseline measure
Forward stage movement is the desired outcome -determining any forward stage movement in considering CRC screening either from Precontemplation to contemplation or from precontemplation to action
Primary Outcome -differences in CRC screening adherence, when controlling for adherence to BC screening at baseline, among women who are randomized to 1) usual care; 2) a TIWeb; 3) a CSC, and 4) a TIWeb plus a CSC.
时间窗: 6 months from the baseline measure
any CRC test (either a stool test or colonoscopy) receipt of a stool test or a colonoscopy
次要结局
- Secondary outcome:Intervention Costs(6 months from the baseline measure)
研究者
Victoria L. Champion
Distinguished Professor Edward and Sara Stam Culliper named Professor Associate Director Cancer Prevention and Control
Indiana University