Colorectal CancerNCT00838318
Colon Cancer Screening in First-Degree Relatives of Hispanic Colorectal Cancer (CRC) Patients
An observational study of Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To evaluate knowledge, beliefs, attitudes and values that influence perceptions and utilization of colorectal cancer screening (CRCS) among first-degree relatives of Hispanic CRC patients. 2. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Mar 2010
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Key Informants from Houston Hispanic Health Coaltion having professional expertise relevant to this study; MDACC Hispanic/Latino CRC Patients, age 18 - 60 years with first degree relatives between age 40 - 70; First-degree relatives (siblings and children) of the MDACC CRC cancer patients recruited to this study, who are aged 40 - 70 years.
Who may be able to join
- Key Informants: Persons will be identified as potentially eligible key informants if they are: 1) members of the Houston Hispanic Health Coalition, or if they are identified through the Houston Hispanic Health Coalition as having professional expertise relevant to this study. 2) Able to speak English or Spanish. 3) Able to provide informed consent.
- CRC Patients: Eligibility criteria include: 1) Living MDACC patients with a personal history of colorectal adenocarcinoma (diagnosed as local or regional disease), who are between the ages of 18 and 60 years, who are identified as Hispanic/Latino, and who have living first degree relatives (siblings or children) between the ages of 40 and 70. 2) Able to provide informed consent. Eligible persons may speak either English or Spanish.
- First-degree relatives (FDRs): Eligibility criteria include: 1) First-degree relatives (siblings and children) of the MDACC CRC cancer patients who are recruited to this study, who are 40 to 70 years of age. 2) Able to provide informed consent. Eligible persons may speak either English or Spanish.
- Note: As described in the above inclusion criteria, this protocol involves recruiting and interviewing of key informants, CRC patients, and eligible first-degree relatives (FDRs) of CRC patients for three phases of the study.
Who cannot join
- CRC Patients: CRC patients will be excluded if they have a history of a known hereditary CRC syndrome (e.g., HNPCC, familial polyposis) or inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease), or were diagnosed with distant metastases.
- First degree relatives: FDRs of eligible CRC patients will be excluded if they have a history of a known hereditary CRC syndrome (e.g., HNPCC, familial polyposis) or inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease), or have a personal history of cancer (except non-melanoma skin cancer) or polyps.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colorectal Cancer (CRC) Screening in First-Degree Relatives (FDRs) of Hispanic CRC Patients
Primary Objectives:
- To evaluate knowledge, beliefs, attitudes and values that influence perceptions and utilization of colorectal cancer screening (CRCS) among first-degree relatives of Hispanic CRC patients.
- To assess factors influencing Hispanic CRC patients' communication of CRC risk and screening information to their FDRs.
Secondary Objective:
- To establish the feasibility of recruiting Hispanic CRC patients and their FDRs from the institutional patient database and/or MDACC clinics.
Read the detailed description
CRC PATIENTS AND THEIR FDRS:
You will be asked to complete a questionnaire by telephone interview. The study researcher who calls you will ask for your permission to audiotape the interview. The questionnaire asks about your awareness of screening tests for colorectal cancer, your family's past use of these screening tests, your attitudes toward colorectal cancer screening, and how you discuss colorectal cancer risk and screening with your family and health care providers. Some demographic information also will be collected (such as your age or marital status). The questionnaire will take between 30 and 45 minutes to complete.
Your answers to the questions and your personal information will be kept strictly confidential. Your questionnaire answers will be identified with a code number, rather than a name, so that you cannot be identified. Audiotaped recordings will be destroyed after all the data have been collected and studied (no longer than 5 years).
This is an investigational study. Up to 60 colorectal cancer patients and their close relatives may be enrolled in the study. All will be enrolled at M. D. Anderson.
KEY INFORMANT:
You will be asked to complete a psychosocial interview either in person or by telephone. The study staff member interviewing you will ask you for permission to audiotape the interview. You will be asked to review the interview guides for colorectal cancer patients and their first degree relatives (FDRs), and provide feedback about them. The interviewer will ask for your opinions about Hispanics' awareness and understanding of colorectal cancer screening. You will also be asked for your opinion about cultural beliefs and practices that may influence participation in colorectal cancer screening. The interview will take between 30 and 45 minutes to complete.
Your answers to the questions and your personal information will be kept strictly confidential. Your questionnaire answers will be identified with a code number, rather than a name, so that you cannot be identified. Audiotaped recordings will be destroyed after all the data have been collected and studied (no longer than 5 years).
This is an investigational study. Up to 15 key informants may be enrolled in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Colorectal Cancer
- Being tested
- Interview
- Keywords
- Colorectal CancerScreening, CRC, Hispanic, CRC Patients, First-Degree Relatives, FDRs, Interviews, Colorectal cancer screening, CRCS, Key Informants
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
Audiotaped Phone Interview/Survey, 30 - 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Hispanic CRC Patients | Not described Receives: Behavioral: Interview | |
| Arm 2 FDRs of Hispancic CRC Patients | First-Degree Relatives (FDRs) of Hispanic CRC Patients Receives: Behavioral: Interview | |
| Arm 3 Key Informants | Key informants from Houston Hispanic Health Coalition. Receives: Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
To look at the knowledge, beliefs, and attitudes toward screening for colorectal cancer among Hispanic colorectal cancer patients and their close relatives.
Measured: 5 Years
Secondary outcomes (1)
To study how these families communicate with each other and health care providers about colorectal cancer risk and screening.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startFeb 2004
- Primary completionMar 2010
- Study completionMar 2010
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 M.D. Anderson Cancer CenterThe 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Peterson, PhD, MPH, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838318
- Sponsor's protocol ID
- 2004-0039
- Status last verified
- Jul 2012
- First submitted
- 5 Feb 2009
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer (CRC) Screening in First-Degree Relatives (FDRs) of Hispanic CRC Patients
- ClinicalTrials.gov ID
- NCT00838318
- Acronym / sponsor ID
- 2004-0039
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal CancerScreening, CRC, Hispanic, CRC Patients, First-Degree Relatives, FDRs, Interviews, Colorectal cancer screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 6 Feb 2009 (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.
Primary Objectives:
- To evaluate knowledge, beliefs, attitudes and values that influence perceptions and utilization of colorectal cancer screening (CRCS) among first-degree relatives of Hispanic CRC patients.
- To assess factors influencing Hispanic CRC patients' communication of CRC risk and screening information to their FDRs.
Secondary Objective:
- To establish the feasibility of recruiting Hispanic CRC patients and their FDRs from the institutional patient database and/or MDACC clinics.
Detailed description
CRC PATIENTS AND THEIR FDRS:
You will be asked to complete a questionnaire by telephone interview. The study researcher who calls you will ask for your permission to audiotape the interview. The questionnaire asks about your awareness of screening tests for colorectal cancer, your family's past use of these screening tests, your attitudes toward colorectal cancer screening, and how you discuss colorectal cancer risk and screening with your family and health care providers. Some demographic information also will be collected (such as your age or marital status). The questionnaire will take between 30 and 45 minutes to complete.
Your answers to the questions and your personal information will be kept strictly confidential. Your questionnaire answers will be identified with a code number, rather than a name, so that you cannot be identified. Audiotaped recordings will be destroyed after all the data have been collected and studied (no longer than 5 years).
This is an investigational study. Up to 60 colorectal cancer patients and their close relatives may be enrolled in the study. All will be enrolled at M. D. Anderson.
KEY INFORMANT:
You will be asked to complete a psychosocial interview either in person or by telephone. The study staff member interviewing you will ask you for permission to audiotape the interview. You will be asked to review the interview guides for colorectal cancer patients and their first degree relatives (FDRs), and provide feedback about them. The interviewer will ask for your opinions about Hispanics' awareness and understanding of colorectal cancer screening. You will also be asked for your opinion about cultural beliefs and practices that may influence participation in colorectal cancer screening. The interview will take between 30 and 45 minutes to complete.
Your answers to the questions and your personal information will be kept strictly confidential. Your questionnaire answers will be identified with a code number, rather than a name, so that you cannot be identified. Audiotaped recordings will be destroyed after all the data have been collected and studied (no longer than 5 years).
This is an investigational study. Up to 15 key informants may be enrolled in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Hispanic CRC Patients | – | Behavioral: Interview |
| Arm 2 FDRs of Hispancic CRC Patients | – | Behavioral: InterviewFirst-Degree Relatives (FDRs) of Hispanic CRC Patients |
| Arm 3 Key Informants | – | Behavioral: InterviewKey informants from Houston Hispanic Health Coalition. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Key Informants from Houston Hispanic Health Coaltion having professional expertise relevant to this study; MDACC Hispanic/Latino CRC Patients, age 18 - 60 years with first degree relatives between age 40 - 70; First-degree relatives (siblings and children) of the MDACC CRC cancer patients recruited to this study, who are aged 40 - 70 years.
Key inclusion criteria (4 listed)
- Key Informants: Persons will be identified as potentially eligible key informants if they are: 1) members of the Houston Hispanic Health Coalition, or if they are identified through the Houston Hispanic Health Coalition as having professional expertise relevant to this study. 2) Able to speak English or Spanish. 3) Able to provide informed consent.
- CRC Patients: Eligibility criteria include: 1) Living MDACC patients with a personal history of colorectal adenocarcinoma (diagnosed as local or regional disease), who are between the ages of 18 and 60 years, who are identified as Hispanic/Latino, and who have living first degree relatives (siblings or children) between the ages of 40 and 70. 2) Able to provide informed consent. Eligible persons may speak either English or Spanish.
- First-degree relatives (FDRs): Eligibility criteria include: 1) First-degree relatives (siblings and children) of the MDACC CRC cancer patients who are recruited to this study, who are 40 to 70 years of age. 2) Able to provide informed consent. Eligible persons may speak either English or Spanish.
- Note: As described in the above inclusion criteria, this protocol involves recruiting and interviewing of key informants, CRC patients, and eligible first-degree relatives (FDRs) of CRC patients for three phases of the study.
Key exclusion criteria (2 listed)
- CRC Patients: CRC patients will be excluded if they have a history of a known hereditary CRC syndrome (e.g., HNPCC, familial polyposis) or inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease), or were diagnosed with distant metastases.
- First degree relatives: FDRs of eligible CRC patients will be excluded if they have a history of a known hereditary CRC syndrome (e.g., HNPCC, familial polyposis) or inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease), or have a personal history of cancer (except non-melanoma skin cancer) or polyps.
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 |
|---|---|---|
| InterviewAudiotaped Phone Interview/Survey, 30 - 45 minutes. | Behavioural | Arm 1 Hispanic CRC Patients, Arm 2 FDRs of Hispancic CRC Patients, Arm 3 Key Informants |
Primary outcome
To look at the knowledge, beliefs, and attitudes toward screening for colorectal cancer among Hispanic colorectal cancer patients and their close relatives.
Time frame: 5 Years
1 secondary outcome
To study how these families communicate with each other and health care providers about colorectal cancer risk and screening.
Time frame: 5 Years
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 30 Jul 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Susan Peterson, PhD, MPH principal investigator
UT MD Anderson Cancer Center
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 M.D. Anderson Cancer Center 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 4 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 30 Jul 2012. 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 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?
To look at the knowledge, beliefs, and attitudes toward screening for colorectal cancer among Hispanic colorectal cancer patients and their close relatives. (time frame: 5 Years). It is what the study was designed to measure, not a finding.
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 30 Jul 2012.