Increasing Colorectal and Breast Cancer Screening in Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Increasing Colorectal and Breast Cancer Screening in Women

Conditions
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Breast Cancer Female, Colorectal Cancer

Intervention / Treatment
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* Behavioral: TIWeb
* Behavioral: CSC
* Behavioral: UC
* Behavioral: TIWeb+CSC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: We propose a prospective randomized 2x2 factorial design: 1)usual care; 2) a TIWeb; 3) a Cancer Screening Call (CSC), and 4 a TIWEB+ a Cancer Screening Call (CSC). The intervention will be tested in 2 groups of women. Group A will include women who are nonadherent to CRC but adherent to BC screening guidelines. Group B will include women who are nonadherent to both CRC and BC screening guidelines.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Usual Care (UC)<br>The usual care group received usual care that varies dependent upon the practice setting. | Behavioral: UC<br>* Intervention: The usual care group received usual care that varies dependent upon the practice setting.<br>* Other names: Usual Care;|
| Active Comparator: TIWeb<br>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. | Behavioral: TIWeb<br>* Intervention: TIWeb 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.<br>* Other names: Tailored Web Intervention;|
| Active Comparator: Cancer Screening Call (CSC)<br>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. | Behavioral: CSC<br>* Intervention: 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.<br>* Other names: Cancer Screening Call;|
| Active Comparator: TIWeb+CSC<br>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. | Behavioral: TIWeb+CSC<br>* Intervention: 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.<br>* Other names: Tailored Web Intervention + Cancer Screening Call;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | any CRC test (either a stool test or colonoscopy) receipt of a stool test or a colonoscopy | 6 months from the baseline measure | 
| 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. | 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 | 6 months from the baseline measure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome:Intervention Costs | 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. | 6 months from the baseline measure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer screening beliefs, cost-effectiveness, demographics, tailored intervention, breast cancer screening, colorectal cancer screening, cervical cancer screening