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Increasing Colorectal and Breast Cancer Screening in Women (COBRA)

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ClinicalTrials.gov Identifier: NCT03279198
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Victoria L. Champion, Indiana University

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:

  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.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Colorectal Cancer Behavioral: TIWeb Behavioral: CSC Behavioral: UC Behavioral: TIWeb+CSC Not Applicable

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  (Clinical Trial)
Actual Enrollment : 1196 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Increasing Colorectal and Breast Cancer Screening in Women
Actual Study Start Date : July 22, 2010
Actual Primary Completion Date : September 15, 2015
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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 Name: 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 Name: 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 Name: 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 Name: Tailored Web Intervention + Cancer Screening Call



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women between the ages from 50 - 75.
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279198


Sponsors and Collaborators
Indiana University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Victoria Champion, PhD Indiana University School of Medicine
  Study Documents (Full-Text)

Documents provided by Victoria L. Champion, Indiana University:
Informed Consent Form  [PDF] June 11, 2014


Publications:
American Cancer Society. Cancer Facts and Figures, 2008. American Cancer Society. 2008.
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
American Cancer Society. Cancer Facts & Figures 2009. Atlanta; 2009 Contract No.: Document Number|.
Champion V, Springston J, Hui S, Saywell RM, Jr., Zollinger TW, Ray D. Community intervention to increase mammography screening (funded research R01CA77736). Bethesda, MD: National Cancer Institute; 1998-2002 Contract No.: Document Number|.
American Cancer Society. Cancer prevention & early detection facts & figures 2005. Atlanta: American Cancer Society; 2005 Contract No.: Document Number|.
Agency for Healthcare Research and Quality. Screening for breast cancer. Recommendations and rationale: Agency for Healthcare Research and Quality; 2002 February 2002 Contract No.: Document Number|.
Kreuter M, Lezin N, Krueter M, Green L. Community health promotion ideas that work. Boston: Jones and Bartlet; 1998.
Skinner CS, Champion VL, Menon U, Seshadri R. Racial and educational differences in mammography-related perceptions among 1,336 nonadherent women. Journal of Psychosocial Oncology. 2002;20:1-18.
Kreuter MW, Farrell D, Olevitch L, Brennan L. Tailoring health messages: customizing communication with computer technology. Mahwah: Lawrence Erlbaum Associates; 2000.
Rimal RN, Flora JA. Interactive technology attributes in health promotion: practical and theoretical issues. In: Street RL, Gold WR, Manning T, editors. Health Promotion and Interactive Technology: Theoretical Applications and Future Directions. Mahwah: Lawrence Erlbaum Associates; 1997. p. 19- 38.
Pingree S, Hawkins RP, Gustafson DH, Boberg E, Bricker E, Wise M, et al. Will the disadvantaged ride the information highway? Hopeful answers from a computer-based health crisis system. Journal of Broadcasting & Electronic Media. 1996;40(3):331-53.
CDRinfo.com. Blu-ray penetration on Rise, Report Says2008 [cited 2008 October 20]: Available from: http://www.cdrinfo.com/sections/news/Details.aspx?NewsId=22933.
Nielsen. Neilsen Media Report. 2008 [updated 2008; cited 2008 September 15]; Available from: htpp://www.nielsenmedia.com.
Becker MH. The Health Belief Model and personal health behavior. Becker MH, editor. San Francisco: Society for Public Health Education; 1974.
Hovland CI, Janis IL, Kelley HH. Communication and Persuasion. Psychological studies of opinion change. New Haven: Yale University Press; 1953.
Petty RE, Cacioppo JT. Attitudes and persuasion--classic and contemporary approaches. Boulder, CO: Westview Press; 1996.
Morgan DL. Focus groups as qualitative research. 2nd ed. Thousand Oaks, CA: Sage Publications; 1997.
Glaser BG, Strauss AL. The discovery of grounded theory: strategies for qualitative research. Paperback ed. Hawthorne, NY: Aldine de Gruyter; 1967.
Lincoln YS, Guba EG. Naturalistic inquiry. Newbury Park: CA: Sage; 1985.
Rawl S, Champion VL, Menon U, Loehrer P, Vance G, Skinner CS. Validation of scales to measure benefits and barriers to colorectal cancer screening. Journal of Psychosocial Oncology. 2001;19(3/4):47-63.
Rawl S, Champion V, Menon U, Loehrer P, Vance G, Hunter C, et al. Differences on health beliefs by stage of readiness to screen for colorectal cancer among first-degree relatives of affected individuals. Ann Behav Med. 2001;23(Supplement):S202.
Menon U. Factors associated with colorectal cancer screening in an average risk population [Dissertation]. Indianapolis, IN: Indiana University; 2000.
Hosmer DW, Lemeshow S. Applied logistic regression. 2nd ed. New York: Wiley; 2000.
Gold MR, Gold SR, Weinstein MC. Cost-effectiveness in health and medicine. Marthe R. Gold SRG, Milton C. Weinstein, editor. New York, NY: Oxford University Press; 1996.
Drummond MF, Sculpher MJ, Torrance GW, O'Brien BJ, Stoddart GL. Methods for the economic evaluation of health care programmes. 3rd ed. Oxford: Oxford University Press; 2005.
Briggs AH. Handling uncertainty in economic evaluation and presenting the results. Drummond M, Maguire, A., editor. Oxford: Oxford University Press; 2001.
Westfall PH, Young SS. Resampling-based multiple testing: examples and methods for P-value adjustment. New York: Wiley; 1993.
SPSS. Statistical package for the social sciences, 15.0 for Windows. 15.0 for Windows ed. Chicago: SPSS, Inc.; 2006.

Responsible Party: Victoria L. Champion, Distinguished Professor Edward and Sara Stam Culliper named Professor Associate Director Cancer Prevention and Control, Indiana University
ClinicalTrials.gov Identifier: NCT03279198     History of Changes
Other Study ID Numbers: 1009001808
5R01CA136940-05 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: January 1st, 2017 - March 31st, 2020.
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Victoria L. Champion, Indiana University:
breast cancer screening
colorectal cancer screening
cervical cancer screening
cancer screening beliefs
cost-effectiveness
demographics
tailored intervention

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases