Colorectal CancerNCT00145860
Do Patients With Colorectal Cancer Understand That Their Family is at Risk?
An observational study of Colorectal Cancer, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to assess whether patients with colorectal cancer understand that their first-degree relatives are at increased risk of getting the cancer themselves and therefore should be screened early. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Aug 2005
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were diagnosed with CRC and received first treatment here or elsewhere and patients who were diagnosed elsewhere and received their first treatment here. All are currently followed here and still alive.
Who cannot join
- Patients in the registry who are not followed here, patients with Familial Adenomatous Polyposis, patients with Hereditary Non-Polyposis Colorectal Cancer, and patients with no siblings or children.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Patients With Colorectal Cancer Understand That Their Family is at Increased Risk?
The purpose of this study is to assess whether patients with colorectal cancer understand that their first-degree relatives are at increased risk of getting the cancer themselves and therefore should be screened early. Among patients who do understand the risks to their family, we plan to determine who they identify as the source of their information and whether they have acted upon this information and advised family members to be screened. We hypothesize that many patients with colorectal cancer do not have a correct understanding of the risks to their first-degree relatives and the recommendations that they be screened early.
If this hypothesis is shown to be true, it can be used to direct improved and more diligent patient education. This, in turn, will hopefully increase the low screening rates among first-degree relatives, and, thereby, save lives in this high-risk population.
Read the detailed description
- The primary physician of patients with colorectal cancer will be contacted and asked permission to contact their patient to discuss his or her understanding of familial risk before patient is contacted.
- A letter will be sent to all patients prior to being contacted, notifying them that all identifying information will be kept confidential and they may decline to participate at any time.
- Patients will be called and asked a series of questions about their understanding of familial risk of colon cancer, the need for early screening and where they learned what they know. If the patient has lacking knowledge they will be educated.
- Each patient will be sent informational brochures about colon cancer after the phone survey.
- Six months later, the patients will be contacted again and asked a series of questions about their understanding of familial risk of colon cancer and the need for early screening to access how much impact the informational brochures had on their knowledge of cancer risk. Patients will be asked one additional demographic question about the highest level of education that they have completed.
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startApr 2002
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 650 participants
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Rubin, M.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145860
- Sponsor's protocol ID
- 11589A
- Status last verified
- Sep 2013
- First submitted
- 1 Sep 2005
- Last updated
- 5 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Patients With Colorectal Cancer Understand That Their Family is at Increased Risk?
- ClinicalTrials.gov ID
- NCT00145860
- Acronym / sponsor ID
- 11589A
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 650 participants
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Apr 2002
- Study completion
- Aug 2005
- First posted
- 5 Sep 2005 (estimated)
- 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.
The purpose of this study is to assess whether patients with colorectal cancer understand that their first-degree relatives are at increased risk of getting the cancer themselves and therefore should be screened early. Among patients who do understand the risks to their family, we plan to determine who they identify as the source of their information and whether they have acted upon this information and advised family members to be screened. We hypothesize that many patients with colorectal cancer do not have a correct understanding of the risks to their first-degree relatives and the recommendations that they be screened early.
If this hypothesis is shown to be true, it can be used to direct improved and more diligent patient education. This, in turn, will hopefully increase the low screening rates among first-degree relatives, and, thereby, save lives in this high-risk population.
Detailed description
- The primary physician of patients with colorectal cancer will be contacted and asked permission to contact their patient to discuss his or her understanding of familial risk before patient is contacted.
- A letter will be sent to all patients prior to being contacted, notifying them that all identifying information will be kept confidential and they may decline to participate at any time.
- Patients will be called and asked a series of questions about their understanding of familial risk of colon cancer, the need for early screening and where they learned what they know. If the patient has lacking knowledge they will be educated.
- Each patient will be sent informational brochures about colon cancer after the phone survey.
- Six months later, the patients will be contacted again and asked a series of questions about their understanding of familial risk of colon cancer and the need for early screening to access how much impact the informational brochures had on their knowledge of cancer risk. Patients will be asked one additional demographic question about the highest level of education that they have completed.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were diagnosed with CRC and received first treatment here or elsewhere and patients who were diagnosed elsewhere and received their first treatment here. All are currently followed here and still alive.
Key exclusion criteria (1 listed)
- Patients in the registry who are not followed here, patients with Familial Adenomatous Polyposis, patients with Hereditary Non-Polyposis Colorectal Cancer, and patients with no siblings or children.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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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.
David Rubin, M.D. principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by University of Chicago 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 5 Sep 2013. 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. 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 was stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
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 Sep 2013.