Increasing Colorectal and Breast Cancer Screening in Women
NCT ID: NCT03279198
Last Updated: 2017-09-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
1196 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-07-22
Study Completion Date
2017-05-31
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:
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.
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.
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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.
Conditions
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Breast Cancer Female
Colorectal Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
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 Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Usual Care (UC)
The usual care group received usual care that varies dependent upon the practice setting.
Group Type
PLACEBO_COMPARATOR
UC
Intervention Type
BEHAVIORAL
Intervention: The usual care group received usual care that varies dependent upon the practice setting.
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.
Group Type
ACTIVE_COMPARATOR
TIWeb
Intervention Type
BEHAVIORAL
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.
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.
Group Type
ACTIVE_COMPARATOR
CSC
Intervention Type
BEHAVIORAL
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.
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.
Group Type
ACTIVE_COMPARATOR
TIWeb+CSC
Intervention Type
BEHAVIORAL
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.
Interventions
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TIWeb
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.
Intervention Type
BEHAVIORAL
CSC
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.
Intervention Type
BEHAVIORAL
UC
Intervention: The usual care group received usual care that varies dependent upon the practice setting.
Intervention Type
BEHAVIORAL
TIWeb+CSC
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.
Intervention Type
BEHAVIORAL
Other Intervention Names
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Tailored Web Intervention
Cancer Screening Call
Usual Care
Tailored Web Intervention + Cancer Screening Call
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
* 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
* 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
Minimum Eligible Age
50 Years
Maximum Eligible Age
75 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
Indiana University
OTHER
Sponsor Role
lead
Responsible Party
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Victoria L. Champion
Distinguished Professor Edward and Sara Stam Culliper named Professor Associate Director Cancer Prevention and Control
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Victoria Champion, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
References
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Huang D, Lairson DR, Chung TH, Monahan PO, Rawl SM, Champion VL. Economic Evaluation of Web- versus Telephone-based Interventions to Simultaneously Increase Colorectal and Breast Cancer Screening Among Women. Cancer Prev Res (Phila). 2021 Sep;14(9):905-916. doi: 10.1158/1940-6207.CAPR-21-0009. Epub 2021 Jul 9.
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DERIVED
Champion VL, Christy SM, Rakowski W, Lairson DR, Monahan PO, Gathirua-Mwangi WG, Stump TE, Biederman EB, Kettler CD, Rawl SM. An RCT to Increase Breast and Colorectal Cancer Screening. Am J Prev Med. 2020 Aug;59(2):e69-e78. doi: 10.1016/j.amepre.2020.03.008.
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DERIVED
Lairson DR, Chung TH, Huang D, Stump TE, Monahan PO, Christy SM, Rawl SM, Champion VL. Economic Evaluation of Tailored Web versus Tailored Telephone-Based Interventions to Increase Colorectal Cancer Screening among Women. Cancer Prev Res (Phila). 2020 Mar;13(3):309-316. doi: 10.1158/1940-6207.CAPR-19-0376. Epub 2020 Jan 22.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1009001808
Identifier Type: -
Identifier Source: org_study_id
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