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Increasing Colorectal and Breast Cancer Screening in Women (COBRA)

Primary Purpose

Breast Cancer Female, Colorectal Cancer

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

TIWeb

CSC

TIWeb+CSC

About this trial

This is an interventional prevention trial for Breast Cancer Female focused on measuring breast cancer screening, colorectal cancer screening, cervical cancer screening, cancer screening beliefs, cost-effectiveness, demographics, tailored intervention

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Usual Care (UC)

TIWeb

Cancer Screening Call (CSC)

TIWeb+CSC

Arm Description

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

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.

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 ((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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03279198

First Posted

August 22, 2017

Last Updated

September 8, 2017

Sponsor

Indiana University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03279198

Brief Title

Increasing Colorectal and Breast Cancer Screening in Women

Acronym

COBRA

Official Title

Increasing Colorectal and Breast Cancer Screening in Women

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

July 22, 2010 (Actual)

Primary Completion Date

September 15, 2015 (Actual)

Study Completion Date

May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer Female, Colorectal Cancer

Keywords

breast cancer screening, colorectal cancer screening, cervical cancer screening, cancer screening beliefs, cost-effectiveness, demographics, tailored intervention

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

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)

Allocation

Randomized

Enrollment

1196 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual Care (UC)

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

TIWeb

Arm Type

Active Comparator

Arm Description

Arm Title

Cancer Screening Call (CSC)

Arm Type

Active Comparator

Arm Description

Arm Title

TIWeb+CSC

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

TIWeb

Other Intervention Name(s)

Tailored Web Intervention

Intervention Description

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

Intervention Name(s)

CSC

Other Intervention Name(s)

Cancer Screening Call

Intervention Description

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

Intervention Name(s)

Other Intervention Name(s)

Usual Care

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

TIWeb+CSC

Other Intervention Name(s)

Tailored Web Intervention + Cancer Screening Call

Intervention Description

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.

Primary Outcome Measure Information:

Title

Description

any CRC test (either a stool test or colonoscopy) receipt of a stool test or a colonoscopy

Time Frame

6 months from the baseline measure

Title

Description

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

Time Frame

6 months from the baseline measure

Secondary Outcome Measure Information:

Title

Secondary outcome:Intervention Costs

Description

Time Frame

6 months from the baseline measure

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Women between the ages from 50 - 75.

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Victoria Champion, PhD

Organizational Affiliation

Indiana University School of Medicine

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

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Increasing Colorectal and Breast Cancer Screening in Women

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