Increasing Colorectal and Breast Cancer Screening in Women (COBRA)

Indiana University

Status: Completed

Conditions: Breast Cancer Female; Colorectal Cancer

Treatments: Behavioral: CSC; Behavioral: TIWeb; Behavioral: UC; Behavioral: TIWeb+CSC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03279198

1009001808

5R01CA136940-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,196 patients

Sex: Female

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,196 participants in 4 patient groups, including a placebo group

Usual Care (UC)

Placebo Comparator group

Description:

The usual care group received usual care that varies dependent upon the practice setting.

Treatment:

Behavioral: UC

TIWeb

Active Comparator group

Description:

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.

Treatment:

Behavioral: TIWeb

Cancer Screening Call (CSC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: CSC

TIWeb+CSC

Active Comparator group

Description:

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.

Treatment:

Behavioral: TIWeb+CSC