NCT06242197

Brief Summary

CRC patients were enrolled and asked about their FDR contacts These FDRs were telephoned and enrolled and randomized to receive either written advice and verbal advice about their cancer risk and screening methods. These FDRs were telephoned after 2 weeks to evaluate their knowledge about CRC risk and method of screening to see which method of giving advice was better.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 29, 2025

Status Verified

December 1, 2024

Enrollment Period

1.4 years

First QC Date

January 28, 2024

Last Update Submit

May 22, 2025

Conditions

Keywords

Colorectal cancerFirst degree relativeCancer screeningColonoscopy screeningFamily history of colorectal cancer

Outcome Measures

Primary Outcomes (1)

  • The effectiveness of written advice VS. standard verbal advice in transferring knowledge to first degree relatives of colorectal cancer patients

    Result of questionnaire about knowing their increase cancer risk

    3 weeks

Secondary Outcomes (2)

  • Ascertaining the problem of communicating medical advice between patient and first degree relatives

    3 weeks

  • Determining the knowledge level about colorectal cancer in first degree relatives of CRC patients

    3 weeks

Study Arms (2)

written advice

EXPERIMENTAL

written advice (in leaflet form) was given to CRC patients to give to first degree relatives, or send to first degree relatives directly. this leaflet contained information about cancer risk and recommended screening methods.

Other: written advice

standard verbal advice

ACTIVE COMPARATOR

verbal advice about cancer risk and screening methods was given to CRC patients to pass on to their first degree relatives

Other: written advice

Interventions

written advice (in leaflet form) was given to CRC patients to give to first degree relatives, or send to first degree relatives directly. this leaflet contained information about cancer risk and recommended screening methods.

standard verbal advicewritten advice

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First degree relatives of patient with colorectal cancer

You may not qualify if:

  • First degree relatives whom already diagnosed of colorectal cancer
  • First degree relatives whom have colorectal cancer from genetic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramanthibodi Hospital

Bangkok, Bangkok, 10400, Thailand

Location

Related Publications (17)

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    PMID: 26917541BACKGROUND
  • O'Reilly M, Linehan A, Krstic A, Kolch W, Sheahan K, Winter DC, Mc Dermott R. Oncotherapeutic Strategies in Early Onset Colorectal Cancer. Cancers (Basel). 2023 Jan 16;15(2):552. doi: 10.3390/cancers15020552.

    PMID: 36672501BACKGROUND
  • Fedirko V, Tramacere I, Bagnardi V, Rota M, Scotti L, Islami F, Negri E, Straif K, Romieu I, La Vecchia C, Boffetta P, Jenab M. Alcohol drinking and colorectal cancer risk: an overall and dose-response meta-analysis of published studies. Ann Oncol. 2011 Sep;22(9):1958-1972. doi: 10.1093/annonc/mdq653. Epub 2011 Feb 9.

    PMID: 21307158BACKGROUND
  • Song M, Emilsson L, Roelstraete B, Ludvigsson JF. Risk of colorectal cancer in first degree relatives of patients with colorectal polyps: nationwide case-control study in Sweden. BMJ. 2021 May 4;373:n877. doi: 10.1136/bmj.n877.

    PMID: 33947661BACKGROUND
  • Lowery JT, Ahnen DJ, Schroy PC 3rd, Hampel H, Baxter N, Boland CR, Burt RW, Butterly L, Doerr M, Doroshenk M, Feero WG, Henrikson N, Ladabaum U, Lieberman D, McFarland EG, Peterson SK, Raymond M, Samadder NJ, Syngal S, Weber TK, Zauber AG, Smith R. Understanding the contribution of family history to colorectal cancer risk and its clinical implications: A state-of-the-science review. Cancer. 2016 Sep 1;122(17):2633-45. doi: 10.1002/cncr.30080. Epub 2016 Jun 3.

    PMID: 27258162BACKGROUND
  • Butterworth AS, Higgins JP, Pharoah P. Relative and absolute risk of colorectal cancer for individuals with a family history: a meta-analysis. Eur J Cancer. 2006 Jan;42(2):216-27. doi: 10.1016/j.ejca.2005.09.023. Epub 2005 Dec 9.

    PMID: 16338133BACKGROUND
  • Wilkinson AN, Lieberman D, Leontiadis GI, Tse F, Barkun AN, Abou-Setta A, Marshall JK, Samadder J, Singh H, Telford JJ, Tinmouth J, Leddin D. Colorectal cancer screening for patients with a family history of colorectal cancer or adenomas. Can Fam Physician. 2019 Nov;65(11):784-789.

    PMID: 31722908BACKGROUND
  • Tung SY, Wu CS. Risk factors for colorectal adenomas among immediate family members of patients with colorectal cancer in Taiwan: a case-control study. Am J Gastroenterol. 2000 Dec;95(12):3624-8. doi: 10.1111/j.1572-0241.2000.03380.x.

    PMID: 11151903BACKGROUND
  • Courtney RJ, Paul CL, Carey ML, Sanson-Fisher RW, Macrae FA, D'Este C, Hill D, Barker D, Simmons J. A population-based cross-sectional study of colorectal cancer screening practices of first-degree relatives of colorectal cancer patients. BMC Cancer. 2013 Jan 10;13:13. doi: 10.1186/1471-2407-13-13.

    PMID: 23305355BACKGROUND
  • Fuchs CS, Giovannucci EL, Colditz GA, Hunter DJ, Speizer FE, Willett WC. A prospective study of family history and the risk of colorectal cancer. N Engl J Med. 1994 Dec 22;331(25):1669-74. doi: 10.1056/NEJM199412223312501.

    PMID: 7969357BACKGROUND
  • Monahan KJ, Bradshaw N, Dolwani S, Desouza B, Dunlop MG, East JE, Ilyas M, Kaur A, Lalloo F, Latchford A, Rutter MD, Tomlinson I, Thomas HJW, Hill J; Hereditary CRC guidelines eDelphi consensus group. Guidelines for the management of hereditary colorectal cancer from the British Society of Gastroenterology (BSG)/Association of Coloproctology of Great Britain and Ireland (ACPGBI)/United Kingdom Cancer Genetics Group (UKCGG). Gut. 2020 Mar;69(3):411-444. doi: 10.1136/gutjnl-2019-319915. Epub 2019 Nov 28.

    PMID: 31780574BACKGROUND
  • Sung JJ, Ng SC, Chan FK, Chiu HM, Kim HS, Matsuda T, Ng SS, Lau JY, Zheng S, Adler S, Reddy N, Yeoh KG, Tsoi KK, Ching JY, Kuipers EJ, Rabeneck L, Young GP, Steele RJ, Lieberman D, Goh KL; Asia Pacific Working Group. An updated Asia Pacific Consensus Recommendations on colorectal cancer screening. Gut. 2015 Jan;64(1):121-32. doi: 10.1136/gutjnl-2013-306503. Epub 2014 Mar 19.

    PMID: 24647008BACKGROUND
  • Gimeno-Garcia AZ, Hernandez-Alvarez-de-Buylla N, Nicolas-Perez D, Carrillo M, Hernandez G, Quintero E. Colorectal cancer screening in the familial risk population: Is colonoscopy still the strategy of choice? Gastroenterol Hepatol. 2016 May;39(5):352-60. doi: 10.1016/j.gastrohep.2015.09.009. Epub 2015 Nov 4.

    PMID: 26547615BACKGROUND
  • Tsai MH, Xirasagar S, Li YJ, de Groen PC. Colonoscopy screening among US adults aged 40 or older with a family history of colorectal cancer. Prev Chronic Dis. 2015 May 21;12:E80. doi: 10.5888/pcd12.140533.

    PMID: 25996988BACKGROUND
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    PMID: 34824608BACKGROUND
  • Tan KK, Lim TZ, Chan DKH, Chew E, Chow WM, Luo N, Wong ML, Koh GC. Getting the first degree relatives to screen for colorectal cancer is harder than it seems-patients' and their first degree relatives' perspectives. Int J Colorectal Dis. 2017 Jul;32(7):1065-1068. doi: 10.1007/s00384-017-2818-4. Epub 2017 Apr 13.

    PMID: 28409270BACKGROUND
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    PMID: 31616522BACKGROUND

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Thippawan saengnoi, Ph.D

    Ramathibodi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 28, 2024

First Posted

February 5, 2024

Study Start

September 1, 2022

Primary Completion

February 1, 2024

Study Completion

December 1, 2024

Last Updated

May 29, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations