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Completed

NCT Number: NCT03279198

Increasing Colorectal and Breast Cancer Screening in Women

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.

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Key information

Conditions

Breast Cancer Female Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TIWeb

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.

Other names: Tailored Web Intervention

CSC

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.

Other names: Cancer Screening Call

UC

Behavioral

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

Other names: Usual Care

TIWeb+CSC

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.

Other names: Tailored Web Intervention + Cancer Screening Call

Primary outcomes

  1. 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.

    Time frame: 6 months from the baseline measure

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

  2. 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.

    Time frame: 6 months from the baseline measure

    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 outcomes

  1. Secondary outcome:Intervention Costs

    Time frame: 6 months from the baseline measure

    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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: COBRA

Important dates

Study start
2010
Primary completion
2015
Study completion
2017
First posted
Sep 12, 2017
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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