Increasing Colorectal and Breast Cancer Screening in Women (COBRA)

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Breast Cancer Female
• Intervention / Treatment: Behavioral: UC; Behavioral: TIWeb; Behavioral: CSC; Behavioral: TIWeb+CSC

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 Type: Interventional
• Enrollment (Actual): 1196
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Usual Care (UC); The usual care group received usual care that varies dependent upon the practice setting.	Behavioral: UC; Intervention: The usual care group received usual care that varies dependent upon the practice setting.; Other Names: Usual Care
ACTIVE_COMPARATOR: 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.	Behavioral: 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.; Other Names: Tailored Web Intervention
ACTIVE_COMPARATOR: 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.	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.; Other Names: Cancer Screening Call
ACTIVE_COMPARATOR: 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.	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.; Other Names: Tailored Web Intervention + Cancer Screening Call

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Victoria Champion, PhD, Indiana University School of Medicine

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (ACTUAL): July 22, 2010
• Primary Completion (ACTUAL): September 15, 2015
• Study Completion (ACTUAL): May 31, 2017

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (ACTUAL): September 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 12, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: cost-effectiveness; breast cancer screening; colorectal cancer screening; tailored intervention; cervical cancer screening; cancer screening beliefs; demographics
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Breast Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Breast Neoplasms; Colorectal Neoplasms
• Other Study ID Numbers: 1009001808; 5R01CA136940-05 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified IPD will be made available to other researchers through a HIPAA compliant data storage system (Box Health) that is password protected.
• IPD Sharing Time Frame: January 1st, 2017 - March 31st, 2020.
• IPD Sharing Access Criteria: Research staff solely associated with the study and/or Graduate or Post-Doc students-who are writing related manuscripts - who have been given permission by the Principal Investigator, Victoria Champion can submit a request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No