Increasing Colorectal and Breast Cancer Screening in Women

Not Applicable

Completed

• Conditions: Colorectal Cancer; Breast Cancer Female

• Registration Number: NCT03279198
• Lead Sponsor: Indiana University

Brief Summary

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:

1. usual care;

2. a TIWeb (tailored intervention Website)

3. a CSC (cancer screening call) and

4. 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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-07-22
• Primary Completion: 2015-09-15
• Study Completion: 2017-05-31
• Study First Submitted: 2017-08-22
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-08
• Last Update Submitted: 2017-09-08
• Study First Posted: 2017-09-12
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1196

Inclusion Criteria

• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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.	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.	6 months from the baseline measure	any CRC test (either a stool test or colonoscopy) receipt of a stool test or a colonoscopy

Secondary Outcome Measures

Name	Time	Method
Secondary outcome:Intervention Costs	6 months from the baseline measure	Comparing the cost-effectiveness of four conditions to promote CRC and BC screening , there will be differences in adherence to both CRC and BC screening and stage of adoption, among women who are randomized to 1) usual care; 2) a TIWeb; 3) a CSC, and 4) a TIWeb plus a CSC.