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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06242197
Other study ID # COA. MURA2023/311
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date March 1, 2024

Study information

Verified date January 2024
Source Ramathibodi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

1. Colorectal cancer patients in a tertiary referral hospital who had first degree relatives in the screening range were enrolled into the study. 2. CRC patients and their FDRs were randomized after enrollment into written advice and verbal advice arms 3. CRC patients were asked to give the documents or verbal advice to FDR within 2 wks. 4. A telephone check was done to see if CRC patients had given or sent the advice their FDR. 5. FDR were telephoned to see if they received the document and assessed their knowledge of FDR risk, screening methods, previous screening and other knowledge about CRC. 6. FDRs were given information over the telephone about CRC risk and screening and then asked whether they wanted to have screening or not.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 180
Est. completion date March 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria: - First degree relatives of patient with colorectal cancer Exclusion Criteria: - First degree relatives whom already diagnosed of colorectal cancer - First degree relatives whom have colorectal cancer from genetic disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
written advice
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.

Locations

Country Name City State
Thailand Ramanthibodi Hospital Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (17)

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. — View Citation

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 — View Citation

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 S — View Citation

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. — View Citation

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. — View Citation

Hatamian S, Hadavandsiri F, Momenimovahed Z, Salehiniya H. Barriers and facilitators of colorectal cancer screening in Asia. Ecancermedicalscience. 2021 Sep 13;15:1285. doi: 10.3332/ecancer.2021.1285. eCollection 2021. — View Citation

Karahalios A, Simpson JA, Baglietto L, MacInnis RJ, Hodge AM, Giles GG, English DR. Change in weight and waist circumference and risk of colorectal cancer: results from the Melbourne Collaborative Cohort Study. BMC Cancer. 2016 Feb 25;16:157. doi: 10.1186 — View Citation

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. Unders — View Citation

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 — View Citation

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. — View Citation

Rawla P, Sunkara T, Barsouk A. Epidemiology of colorectal cancer: incidence, mortality, survival, and risk factors. Prz Gastroenterol. 2019;14(2):89-103. doi: 10.5114/pg.2018.81072. Epub 2019 Jan 6. — View Citation

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. — View Citation

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 Reco — View Citation

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):10 — View Citation

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. — View Citation

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. — View Citation

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 Physicia — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Ascertaining the problem of communicating medical advice between patient and first degree relatives Questionnaire-interview 3 weeks
Secondary Determining the knowledge level about colorectal cancer in first degree relatives of CRC patients Questionnaire-interview 3 weeks
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