Clinical trial NCT03279198: Increasing Colorectal and Breast Cancer Screening in Women
Official title: Increasing Colorectal and Breast Cancer Screening in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Colorectal Cancer
Keywords: breast cancer screening
colorectal cancer screening
cervical cancer screening
cancer screening beliefs
cost-effectiveness
demographics
tailored intervention
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-09-12
Enrollment: 1196
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 6 months from the baseline measure
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.
timeFrame: 6 months from the baseline measure
Secondary outcomes:
measure: Secondary outcome:Intervention Costs
timeFrame: 6 months from the baseline measure
Other outcomes:
Locations:
Study officials:
affiliation: Indiana University School of Medicine
name: Victoria Champion, PhD
role: PRINCIPAL_INVESTIGATOR
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