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AzTrials

Colorectal CancerNCT03819920

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

A study testing Risk Assessment (CCRAT) in people with Colorectal Cancer, run by Stanford University at 1 site in United States.

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 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. Read more about this study

Who is it for?
Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Colorectal Cancer
What is being tested?
Risk Assessment (CCRAT)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
229 participants
Where
1 siteUnited States
Study dates
6 Oct 2015to 4 Jan 2019
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
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Palo Alto, California, 94305

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Risk Assessment (CCRAT), Usual Care (UC)
Keywords
cancer screening beliefs, colorectal cancer screening
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Risk Assessment (CCRAT)Behavioural

    Also called 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)

  • Usual Care (UC)Behavioural

    Also called UC

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

Study groups in NCT03819920
Study groupRoleWhat they receive
Usual Care (UC)Placebo comparatorPatients receive standardized general information about colorectal cancer screening over the telephone.
Receives: Behavioral: Usual Care (UC)
Risk Assessment (CCRAT)Active comparatorPatient 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)
Receives: Behavioral: Risk Assessment (CCRAT); Behavioral: Usual Care (UC)

What is being measured

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

  1. Screening Behavior: Differences in colorectal cancer screening completion rates between usual care (UC) and CCRAT

    Any CRC screening test completed including stool tests (FOBT (fecal occult blood test), FIT (immunochemical test for fecal blood), stool DNA test), colonoscopy, flexible sigmoidoscopy, double contrast barium enema, CT colonography (virtual colonoscopy)

    Measured: 12 months after intervention

Secondary outcomes (3)

  1. Screening Behavior: Differences in colorectal cancer screening completion rates between usual care (UC) and CCRAT

    Any CRC screening test completed including stool tests (FOBT (fecal occult blood test), FIT (immunochemical test for fecal blood), stool DNA test), colonoscopy, flexible sigmoidoscopy, double contrast barium enema, CT colonography (virtual colonoscopy)

    Measured: 6 months after intervention

  2. Change in intention to screen at 6 months and 12 months

    Differences in progressive behavioral stages of adoption from precontemplation to contemplation to preparation.

    Measured: Immediate after intervention, 6 months and 1 year after intervention

  3. Colorectal cancer screening rates at 12 months as a function of CCRAT score

    Screening completion at 12 months will be compared between the 3 tertiles of CCRAT score in the intervention group to determine whether there is any relationship between absolute CCRAT score and screening completion

    Measured: 12 months after intervention

Timeline

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

  1. First posted29 Jan 2019
  2. Study start6 Oct 2015
  3. Primary completion4 Jan 2019
  4. Study completion4 Jan 2019

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
Parallel groups
Model description
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)
Masking
None (open label)
Enrolment
229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03819920
Sponsor's protocol ID
IRB-32815
Status last verified
Feb 2019
First submitted
22 Jan 2019
Last updated
5 Feb 2019
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 (Stanford Medicine Box) that is password protected

Publications

  • 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.

    PubMed 27593418

  • 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.

    PubMed 30181203

  • 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.

    PubMed 29532054

  • 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.

    PubMed 23419327

  • 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.

    PubMed 26785715

  • 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.

    PubMed 26227576

  • 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.

    PubMed 21271365

  • 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.

    PubMed 21826576

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

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

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

  • 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.

    PubMed 19998273

  • 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.

    PubMed 22490320

  • 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.

    PubMed 24729896

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

    PubMed 22190913

Questions about this trial

What is this clinical trial studying?

A study testing Risk Assessment (CCRAT) in people with Colorectal Cancer, run by Stanford University at 1 site in United States.

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 3 inclusion and 4 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Screening Behavior: Differences in colorectal cancer screening completion rates between usual care (UC) and CCRAT (time frame: 12 months after intervention). 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 NCT03819920, which also lists 25 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 5 Feb 2019.

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