Does Knowing One's Estimated Colorectal Cancer Risk Influence Screening Behavior?

NCT ID: NCT03819920

Last Updated: 2019-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-06

Study Completion Date

2019-01-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed to examine the impact of telephone-based colorectal cancer risk assessment on colorectal screening attitudes and behavior among previously unscreened adults ages 50 to 75.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Colorectal cancer (CRC) remains the 3rd most common cancer in the US. Most CRCs are preventable, but screening participation remains suboptimal. Several factors have been associated with screening compliance, such as perception of CRC risk. Here we study the impact of telephone-based administration of the National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT) compared to usual care.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Usual care of generalized colorectal cancer screening education over telephone versus personalized risk assessment over telephone using National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT)
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Usual Care (UC)

Patients receive standardized general information about colorectal cancer screening over the telephone.

Group Type PLACEBO_COMPARATOR

Usual Care (UC)

Intervention Type BEHAVIORAL

Patients receive standardized general information about colorectal cancer screening over the telephone.

Risk Assessment (CCRAT)

Patient receive personalized colorectal cancer risk assessment over the telephone by answering the questions as outlined in the National Cancer Institute Colorectal Cancer Risk Assessment Tool (https://ccrisktool.cancer.gov/calculator.html)

Group Type ACTIVE_COMPARATOR

Risk Assessment (CCRAT)

Intervention Type BEHAVIORAL

Patient receive personalized colorectal cancer risk assessment over the telephone by answering the questions as outlined in the National Cancer Institute Colorectal Cancer Risk Assessment Tool (https://ccrisktool.cancer.gov/calculator.html)

Usual Care (UC)

Intervention Type BEHAVIORAL

Patients receive standardized general information about colorectal cancer screening over the telephone.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Risk Assessment (CCRAT)

Patient receive personalized colorectal cancer risk assessment over the telephone by answering the questions as outlined in the National Cancer Institute Colorectal Cancer Risk Assessment Tool (https://ccrisktool.cancer.gov/calculator.html)

Intervention Type BEHAVIORAL

Usual Care (UC)

Patients receive standardized general information about colorectal cancer screening over the telephone.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CCRAT UC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient of any participating physician
* Not having had any colorectal cancer screening test prior
* Able to speak English

Exclusion Criteria

* Personal history of inflammatory bowel disease
* Personal history of colorectal cancer
* Personal history of Lynch syndrome or Familial Adenomatous Polyposis
* Have already received colorectal cancer screening
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stanford University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Uri Ladabaum

Professor of Medicine, Director GI Cancer Prevention Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Uri Ladabaum, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford University School of Medicine

Palo Alto, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Miller DP Jr, Denizard-Thompson N, Weaver KE, Case LD, Troyer JL, Spangler JG, Lawler D, Pignone MP. Effect of a Digital Health Intervention on Receipt of Colorectal Cancer Screening in Vulnerable Patients: A Randomized Controlled Trial. Ann Intern Med. 2018 Apr 17;168(8):550-557. doi: 10.7326/M17-2315. Epub 2018 Mar 13.

Reference Type BACKGROUND
PMID: 29532054 (View on PubMed)

Christy SM, Rawl SM. Shared decision-making about colorectal cancer screening: a conceptual framework to guide research. Patient Educ Couns. 2013 Jun;91(3):310-7. doi: 10.1016/j.pec.2013.01.015. Epub 2013 Feb 15.

Reference Type BACKGROUND
PMID: 23419327 (View on PubMed)

Schroy PC 3rd, Duhovic E, Chen CA, Heeren TC, Lopez W, Apodaca DL, Wong JB. Risk Stratification and Shared Decision Making for Colorectal Cancer Screening: A Randomized Controlled Trial. Med Decis Making. 2016 May;36(4):526-35. doi: 10.1177/0272989X15625622. Epub 2016 Jan 19.

Reference Type BACKGROUND
PMID: 26785715 (View on PubMed)

Han PK, Duarte CW, Daggett S, Siewers A, Killam B, Smith KA, Freedman AN. Effects of personalized colorectal cancer risk information on laypersons' interest in colorectal cancer screening: The importance of individual differences. Patient Educ Couns. 2015 Oct;98(10):1280-6. doi: 10.1016/j.pec.2015.07.010. Epub 2015 Jul 19.

Reference Type BACKGROUND
PMID: 26227576 (View on PubMed)

Vernon SW, Bartholomew LK, McQueen A, Bettencourt JL, Greisinger A, Coan SP, Lairson D, Chan W, Hawley ST, Myers RE. A randomized controlled trial of a tailored interactive computer-delivered intervention to promote colorectal cancer screening: sometimes more is just the same. Ann Behav Med. 2011 Jun;41(3):284-99. doi: 10.1007/s12160-010-9258-5.

Reference Type BACKGROUND
PMID: 21271365 (View on PubMed)

Menon U, Belue R, Wahab S, Rugen K, Kinney AY, Maramaldi P, Wujcik D, Szalacha LA. A randomized trial comparing the effect of two phone-based interventions on colorectal cancer screening adherence. Ann Behav Med. 2011 Dec;42(3):294-303. doi: 10.1007/s12160-011-9291-z.

Reference Type BACKGROUND
PMID: 21826576 (View on PubMed)

American Cancer Society. Cancer Facts and Figures 2014. Atlanta, GA: American Cancer Society; 2014.

Reference Type BACKGROUND

American Cancer Society. Colorectal Cancer Facts and Figures, 2014-2016. Atlanta, GA: American Cancer Society; 2014.

Reference Type BACKGROUND

Howlader N, Noone AM, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2010. Bethesda, MD: National Cancer Institute, 2013.

Reference Type BACKGROUND

Volk RJ, Linder SK, Lopez-Olivo MA, Kamath GR, Reuland DS, Saraykar SS, Leal VB, Pignone MP. Patient Decision Aids for Colorectal Cancer Screening: A Systematic Review and Meta-analysis. Am J Prev Med. 2016 Nov;51(5):779-791. doi: 10.1016/j.amepre.2016.06.022. Epub 2016 Sep 2.

Reference Type BACKGROUND
PMID: 27593418 (View on PubMed)

Champion VL, Christy SM, Rakowski W, Gathirua-Mwangi WG, Tarver WL, Carter-Harris L, Cohee AA, Marley AR, Jessup NM, Biederman E, Kettler CD, Stump TE, Monahan P, Lairson DR, Rawl SM. A Randomized Trial to Compare a Tailored Web-Based Intervention and Tailored Phone Counseling to Usual Care for Increasing Colorectal Cancer Screening. Cancer Epidemiol Biomarkers Prev. 2018 Dec;27(12):1433-1441. doi: 10.1158/1055-9965.EPI-18-0180. Epub 2018 Sep 4.

Reference Type BACKGROUND
PMID: 30181203 (View on PubMed)

Edwards BK, Ward E, Kohler BA, Eheman C, Zauber AG, Anderson RN, Jemal A, Schymura MJ, Lansdorp-Vogelaar I, Seeff LC, van Ballegooijen M, Goede SL, Ries LA. Annual report to the nation on the status of cancer, 1975-2006, featuring colorectal cancer trends and impact of interventions (risk factors, screening, and treatment) to reduce future rates. Cancer. 2010 Feb 1;116(3):544-73. doi: 10.1002/cncr.24760.

Reference Type BACKGROUND
PMID: 19998273 (View on PubMed)

Shapiro JA, Klabunde CN, Thompson TD, Nadel MR, Seeff LC, White A. Patterns of colorectal cancer test use, including CT colonography, in the 2010 National Health Interview Survey. Cancer Epidemiol Biomarkers Prev. 2012 Jun;21(6):895-904. doi: 10.1158/1055-9965.EPI-12-0192. Epub 2012 Apr 6.

Reference Type BACKGROUND
PMID: 22490320 (View on PubMed)

Gimeno Garcia AZ, Hernandez Alvarez Buylla N, Nicolas-Perez D, Quintero E. Public awareness of colorectal cancer screening: knowledge, attitudes, and interventions for increasing screening uptake. ISRN Oncol. 2014 Mar 5;2014:425787. doi: 10.1155/2014/425787. eCollection 2014.

Reference Type BACKGROUND
PMID: 24729896 (View on PubMed)

Gimeno Garcia AZ. Factors influencing colorectal cancer screening participation. Gastroenterol Res Pract. 2012;2012:483417. doi: 10.1155/2012/483417. Epub 2011 Dec 1.

Reference Type BACKGROUND
PMID: 22190913 (View on PubMed)

Jepson R, Clegg A, Forbes C, Lewis R, Sowden A, Kleijnen J. The determinants of screening uptake and interventions for increasing uptake: a systematic review. Health Technol Assess. 2000;4(14):i-vii, 1-133. No abstract available.

Reference Type BACKGROUND
PMID: 10984843 (View on PubMed)

Peterson NB, Dwyer KA, Mulvaney SA, Dietrich MS, Rothman RL. The influence of health literacy on colorectal cancer screening knowledge, beliefs and behavior. J Natl Med Assoc. 2007 Oct;99(10):1105-12.

Reference Type BACKGROUND
PMID: 17987913 (View on PubMed)

McCaffery K, Wardle J, Waller J. Knowledge, attitudes, and behavioral intentions in relation to the early detection of colorectal cancer in the United Kingdom. Prev Med. 2003 May;36(5):525-35. doi: 10.1016/s0091-7435(03)00016-1.

Reference Type BACKGROUND
PMID: 12689797 (View on PubMed)

Wardle J, Sutton S, Williamson S, Taylor T, McCaffery K, Cuzick J, Hart A, Atkin W. Psychosocial influences on older adults' interest in participating in bowel cancer screening. Prev Med. 2000 Oct;31(4):323-34. doi: 10.1006/pmed.2000.0725.

Reference Type BACKGROUND
PMID: 11006057 (View on PubMed)

Robb KA, Miles A, Wardle J. Demographic and psychosocial factors associated with perceived risk for colorectal cancer. Cancer Epidemiol Biomarkers Prev. 2004 Mar;13(3):366-72.

Reference Type BACKGROUND
PMID: 15006910 (View on PubMed)

Robb KA, Miles A, Wardle J. Perceived risk of colorectal cancer: sources of risk judgments. Cancer Epidemiol Biomarkers Prev. 2007 Apr;16(4):694-702. doi: 10.1158/1055-9965.EPI-06-0151.

Reference Type BACKGROUND
PMID: 17416759 (View on PubMed)

Bae N, Park S, Lim S. Factors associated with adherence to fecal occult blood testing for colorectal cancer screening among adults in the Republic of Korea. Eur J Oncol Nurs. 2014 Feb;18(1):72-7. doi: 10.1016/j.ejon.2013.09.001. Epub 2013 Oct 31.

Reference Type BACKGROUND
PMID: 24183583 (View on PubMed)

Hodge F, Maliski S, Itty T, Martinez F. Colorectal cancer screening: the role of perceived susceptibility, risk and cultural illness beliefs among American Indians. J Cult Divers. 2014 Summer;21(2):48-55.

Reference Type BACKGROUND
PMID: 25011207 (View on PubMed)

Trauth JM, Ling BS, Weissfeld JL, Schoen RE, Hayran M. Using the transtheoretical model to stage screening behavior for colorectal cancer. Health Educ Behav. 2003 Jun;30(3):322-36. doi: 10.1177/1090198103030003007.

Reference Type BACKGROUND
PMID: 19731499 (View on PubMed)

Yen T, Qin F, Sundaram V, Asiimwe E, Storage T, Ladabaum U. Randomized Controlled Trial of Personalized Colorectal Cancer Risk Assessment vs Education to Promote Screening Uptake. Am J Gastroenterol. 2021 Feb 1;116(2):391-400. doi: 10.14309/ajg.0000000000000963.

Reference Type DERIVED
PMID: 33009045 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://ccrisktool.cancer.gov/

National Cancer Institute Colorectal Cancer Risk Assessment Tool (CCRAT)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB-32815

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Colon Cancer Prevention Study
NCT00924690 COMPLETED NA