Colorectal CancerNCT06242197
Comparing the Effectiveness of Written Vs Verbal Advice for First Degree Relatives of Colorectal Cancer Patients
A study testing written advice in people with Colorectal Cancer, run by Ramathibodi Hospital at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- written advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2022to 1 Dec 2024
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First degree relatives of patient with colorectal cancer
Who cannot join
- First degree relatives whom already diagnosed of colorectal cancer
- First degree relatives whom have colorectal cancer from genetic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effectiveness of Written Advice VS. Standard Verbal Advice in Transferring Knowledge to First Degree Relatives of Colorectal Cancer Patients
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.
Read the detailed description
- Colorectal cancer patients in a tertiary referral hospital who had first degree relatives in the screening range were enrolled into the study.
- CRC patients and their FDRs were randomized after enrollment into written advice and verbal advice arms
- CRC patients were asked to give the documents or verbal advice to FDR within 2 wks.
- A telephone check was done to see if CRC patients had given or sent the advice their FDR.
- 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.
- FDRs were given information over the telephone about CRC risk and screening and then asked whether they wanted to have screening or not.
- Conditions
- Colorectal Cancer
- Being tested
- written advice
- Keywords
- Colorectal cancer, First degree relative, Cancer screening, Colonoscopy screening, Family history of colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
written adviceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: written advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 weeks
Secondary outcomes (2)
Ascertaining the problem of communicating medical advice between patient and first degree relatives
Questionnaire-interview
Measured: 3 weeks
Determining the knowledge level about colorectal cancer in first degree relatives of CRC patients
Questionnaire-interview
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Sep 2022
- Primary completion1 Feb 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thippawan Saengnoi, Ramathibodi Hospital
- Investigators
- Thippawan saengnoi, Ph.D, Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242197
- Sponsor's protocol ID
- COA. MURA2023/311
- Status last verified
- Dec 2024
- First submitted
- 28 Jan 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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/s12885-016-2144-1.
PubMed 26917541O'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.
PubMed 36672501Fedirko 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.
PubMed 21307158Song 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.
PubMed 33947661Lowery 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.
PubMed 27258162Butterworth 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.
PubMed 16338133Wilkinson 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.
PubMed 31722908Tung 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.
PubMed 11151903Courtney 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.
PubMed 23305355Fuchs 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.
PubMed 7969357Monahan 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.
PubMed 31780574Sung 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.
PubMed 24647008Gimeno-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.
PubMed 26547615Tsai 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.
PubMed 25996988Hatamian 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.
PubMed 34824608
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Written Advice VS. Standard Verbal Advice in Transferring Knowledge to First Degree Relatives of Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT06242197
- Acronym / sponsor ID
- COA. MURA2023/311
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, First degree relative, Cancer screening, Colonoscopy screening, Family history of colorectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Colorectal cancer patients in a tertiary referral hospital who had first degree relatives in the screening range were enrolled into the study.
- CRC patients and their FDRs were randomized after enrollment into written advice and verbal advice arms
- CRC patients were asked to give the documents or verbal advice to FDR within 2 wks.
- A telephone check was done to see if CRC patients had given or sent the advice their FDR.
- 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.
- FDRs were given information over the telephone about CRC risk and screening and then asked whether they wanted to have screening or not.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| written advice | Experimental | Other: written advicewritten 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 advice | Active comparator | Other: written adviceverbal advice about cancer risk and screening methods was given to CRC patients to pass on to their first degree relatives |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First degree relatives of patient with colorectal cancer
Key exclusion criteria (2 listed)
- First degree relatives whom already diagnosed of colorectal cancer
- First degree relatives whom have colorectal cancer from genetic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| written advicewritten 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 | standard verbal advice, written advice |
Primary outcome
The effectiveness of written advice VS. standard verbal advice in transferring knowledge to first degree relatives of colorectal cancer patients
Time frame: 3 weeks
Result of questionnaire about knowing their increase cancer risk
2 secondary outcomes
Ascertaining the problem of communicating medical advice between patient and first degree relatives
Time frame: 3 weeks
Determining the knowledge level about colorectal cancer in first degree relatives of CRC patients
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Results publication: PubMed 26917541Karahalios 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/s12885-016-2144-1.
- Results publication: PubMed 36672501O'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.
- Results publication: PubMed 21307158Fedirko 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.
- Results publication: PubMed 33947661Song 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.
- Results publication: PubMed 27258162Lowery 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.
- Results publication: PubMed 16338133Butterworth 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.
- Results publication: PubMed 31722908Wilkinson 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.
- Results publication: PubMed 11151903Tung 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.
- Results publication: PubMed 23305355Courtney 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.
- Results publication: PubMed 7969357Fuchs 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.
- Results publication: PubMed 31780574Monahan 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.
- Results publication: PubMed 24647008Sung 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.
- Clinical guideline for CRC screeningLink provided by the sponsor.
- Clinical guideline for CRC screening in first degree relativesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thippawan saengnoi, Ph.D principal investigator
Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing written advice in people with Colorectal Cancer, run by Ramathibodi Hospital at 1 site in Thailand.
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 1 inclusion and 2 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 29 May 2025. 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 Thailand. 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. 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?
The effectiveness of written advice VS. standard verbal advice in transferring knowledge to first degree relatives of colorectal cancer patients (time frame: 3 weeks). 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 NCT06242197, which also lists 17 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 29 May 2025.