Increasing Colorectal and Breast Cancer Screening in Women

Colorectal Cancer Clinical Trial

— COBRA  

Official title:

Increasing Colorectal and Breast Cancer Screening in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279198
• Other study ID #: 1009001808
• Secondary ID: 5R01CA136940-05
• Status: Completed
• Phase: N/A
• First received: August 22, 2017
• Last updated: September 8, 2017
• Start date: July 22, 2010
• Est. completion date: May 31, 2017

Study information

• Verified date: September 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1196
• Est. completion date: May 31, 2017
• Est. primary completion date: September 15, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Cancer Institute (NCI)

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* Note: There are 145 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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