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Breast Cancer FemaleCOBRANCT03279198

Increasing Colorectal and Breast Cancer Screening in Women

A study testing TIWeb, CSC and UC in people with Breast Cancer Female and Colorectal Cancer, run by Indiana University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer Female, Colorectal Cancer
What is being tested?
TIWeb, CSC and UC
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,196 participants
Where
No sites listed yet
Study dates
22 Jul 2010to 31 May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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.
Read the 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.

Being tested
TIWeb, CSC, UC, TIWeb+CSC
Keywords
breast cancer screening, colorectal cancer screening, cervical cancer screening, cancer screening beliefs, cost-effectiveness, demographics, tailored intervention
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TIWebBehavioural

    Also called Tailored Web Intervention

    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.

  • CSCBehavioural

    Also called Cancer Screening Call

    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.

  • UCBehavioural

    Also called Usual Care

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

  • TIWeb+CSCBehavioural

    Also called Tailored Web Intervention + Cancer Screening Call

    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.

Study groups in NCT03279198
Study groupRoleWhat they receive
Usual Care (UC)Placebo comparatorThe usual care group received usual care that varies dependent upon the practice setting.
Receives: Behavioral: UC
TIWebActive comparatorTIWeb (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.
Receives: Behavioral: TIWeb
Cancer Screening Call (CSC)Active comparatorCSC - 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.
Receives: Behavioral: CSC
TIWeb+CSCActive comparatorTIWeb + 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.
Receives: Behavioral: TIWeb+CSC

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

    Measured: 6 months from the baseline measure

  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.

    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

    Measured: 6 months from the baseline measure

Secondary outcomes (1)

  1. 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.

    Measured: 6 months from the baseline measure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2017
  2. Study start22 Jul 2010
  3. Primary completion15 Sep 2015
  4. Study completion31 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
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)
Enrolment
1,196 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03279198
Sponsor's protocol ID
1009001808
Other IDs
5R01CA136940-05
Acronym
COBRA
Status last verified
Sep 2017
First submitted
22 Aug 2017
Last updated
12 Sep 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified IPD will be made available to other researchers through a HIPAA compliant data storage system (Box Health) that is password protected.

Publications

  • Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available.

    PubMed 33532112

  • Smith RA, Cokkinides V, Eyre HJ. American Cancer Society guidelines for the early detection of cancer, 2006. CA Cancer J Clin. 2006 Jan-Feb;56(1):11-25; quiz 49-50. doi: 10.3322/canjclin.56.1.11.

    PubMed 16449183

  • American Cancer Society. Report finds historic drop in total number of cancer deaths. 2006 [updated 2006; cited]; Available from: http://www.cancer.org/docroot/MED/content/MED_2_lx_American_Cancer_Society_Report_Finds_Drop _in_Total_Cancer_Deaths.asp

  • Breen N, A Cronin K, Meissner HI, Taplin SH, Tangka FK, Tiro JA, McNeel TS. Reported drop in mammography : is this cause for concern? Cancer. 2007 Jun 15;109(12):2405-9. doi: 10.1002/cncr.22723.

    PubMed 17503429

  • Prochaska JJ, Spring B, Nigg CR. Multiple health behavior change research: an introduction and overview. Prev Med. 2008 Mar;46(3):181-8. doi: 10.1016/j.ypmed.2008.02.001. Epub 2008 Feb 6.

    PubMed 18319098

  • Stockwell DH, Woo P, Jacobson BC, Remily R, Syngal S, Wolf J, Farraye FA. Determinants of colorectal cancer screening in women undergoing mammography. Am J Gastroenterol. 2003 Aug;98(8):1875-80. doi: 10.1111/j.1572-0241.2003.07577.x.

    PubMed 12907347

  • Solomon D, Breen N, McNeel T. Cervical cancer screening rates in the United States and the potential impact of implementation of screening guidelines. CA Cancer J Clin. 2007 Mar-Apr;57(2):105-11. doi: 10.3322/canjclin.57.2.105.

    PubMed 17392387

  • Katz ML, Tatum CM, Degraffinreid CR, Dickinson S, Paskett ED. Do cervical cancer screening rates increase in association with an intervention designed to increase mammography usage? J Womens Health (Larchmt). 2007 Jan-Feb;16(1):24-35. doi: 10.1089/jwh.2006.0071.

    PubMed 17324094

  • Champion VL. Strategies to increase mammography utilization. Med Care. 1994 Feb;32(2):118-29. doi: 10.1097/00005650-199402000-00003.

    PubMed 8302104

  • Skinner CS, Strecher VJ, Hospers H. Physicians' recommendations for mammography: do tailored messages make a difference? Am J Public Health. 1994 Jan;84(1):43-9. doi: 10.2105/ajph.84.1.43.

    PubMed 8279610

  • Taplin SH, Barlow WE, Ludman E, MacLehos R, Meyer DM, Seger D, Herta D, Chin C, Curry S. Testing reminder and motivational telephone calls to increase screening mammography: a randomized study. J Natl Cancer Inst. 2000 Feb 2;92(3):233-42. doi: 10.1093/jnci/92.3.233.

    PubMed 10655440

  • American Cancer Society. Cancer Facts & Figures 2009. Atlanta; 2009 Contract No.: Document Number|.

  • Shapiro JA, Seeff LC, Nadel MR. Colorectal cancer-screening tests and associated health behaviors. Am J Prev Med. 2001 Aug;21(2):132-7. doi: 10.1016/s0749-3797(01)00329-4.

    PubMed 11457633

  • Saywell RM Jr, Champion VL, Skinner CS, McQuillen D, Martin D, Maraj M. Cost-effectiveness comparison of five interventions to increase mammography screening. Prev Med. 1999 Nov;29(5):374-82. doi: 10.1006/pmed.1999.0568.

    PubMed 10564629

  • Saywell RM Jr, Champion VL, Zollinger TW, Maraj M, Skinner CS, Zoppi KA, Muegge CM. The cost effectiveness of 5 interventions to increase mammography adherence in a managed care population. Am J Manag Care. 2003 Jan;9(1):33-44.

    PubMed 12549813

Questions about this trial

What is this clinical trial studying?

A study testing TIWeb, CSC and UC in people with Breast Cancer Female and Colorectal Cancer, run by Indiana University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03279198, which also lists 148 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.

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