ColorectalNCT00582829
Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients
An observational study of Colorectal and Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This proposed study will use previous study results to guide the development and evaluation of interventions to improve CRC screening acceptance. The proposed study will evaluate the impact of three interventions to promote CRC screening among siblings in this increased-risk group, who are not currently compliant with… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal, Cancer, Screening
- What is being tested?
- Generic Print Intervention, Tailored Print Intervention and Tailored print plus tailored phone intervention
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to May 2008
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- How old is the participant? (≥ 18 years)
- Is the participant either:
- currently age 40 or above (YES) OR
- within 10 years of the age at which the patient/proband was initially diagnosed with CRC (whichever is the younger age) (YES)
- Is the participant a full or half biological sibling of the patient/proband? (YES)
Who cannot join
- Is the participant currently not compliant with standard CRC screening guidelines? (NO)
- Is the participant English speaking? (YES)
- Does the participant have a primary language other than English? (NO)
- Does the participant have a history of Inflammatory Bowel Disease? (NO)
- Does the participant have a history of colorectal cancer of colorectal polyp? (NO)
- Does the participant have a history of hereditary colorectal cancer syndrome? (Familial Adenomatous Polyposis or Hereditary Nonpolyposis Colorectal Cancer) (NO)
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
This proposed study will use previous study results to guide the development and evaluation of interventions to improve CRC screening acceptance. The proposed study will evaluate the impact of three interventions to promote CRC screening among siblings in this increased-risk group, who are not currently compliant with CRC screening guidelines: 1) a generic print intervention; 2) a tailored print intervention, and; 3) a tailored print plus tailored telephone counseling intervention.
Read the detailed description
First-degree relatives of individuals with CRC are at increased-risk of developing colorectal cancer (CRC). For these increased-risk individuals current guidelines recommend initiating CRC screening a decade earlier than for those at average-risk for CRC; thus, starting at age 40, or 10 years younger than the age at which the affected relative was diagnosed with CRC. In our prior study of 504 at-risk siblings of patients with a history of CRC, diagnosed at age less than 56, we found that approximately 44% of these siblings were not compliant with CRC screening guidelines. Guided by the Transtheoretical, Health Belief and Dual Process models, our prior study identified key attitudinal and non-attitudinal predictors of screening behaviors and intentions.
This proposed study will use these results to guide the development and evaluation of interventions to improve CRC screening acceptance. The proposed study will evaluate the impact of three interventions to promote CRC screening among siblings in this increased-risk group, who are not currently compliant with CRC screening guidelines: 1) a generic print intervention; 2) a tailored print intervention, and; 3) a tailored print plus tailored telephone counseling intervention.
Siblings in the generic print condition will receive a pamphlet about colorectal cancer screening published by the Center for Disease Control. Siblings in the tailored print and telephone counseling conditions will receive messages tailored specifically to their responses on targeted attitudinal and non-attitudinal measures. Five hundred twenty four siblings meeting eligibility criteria will be randomly assigned to one of the three conditions after a baseline interview assessing CRC screening behaviors and attitudes, and it is anticipated that 427 siblings will complete the study. For siblings in the tailored conditions, baseline information will be utilized to design the tailored messages. After receiving the intervention information, participants will be interviewed again six months later regarding CRC screening behaviors and attitudes to assess the impact of the intervention.
- Conditions
- Colorectal, Cancer, Screening, Intervention
- Being tested
- Generic Print Intervention, Tailored Print Intervention, Tailored print plus tailored phone intervention
- Keywords
- Colorectal, Cancer, Screening, Intervention, Family
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generic Print InterventionOther
Generic Print Intervention: The generic print intervention will consist of the pamphlet, "Colorectal Cancer Screening Saves Lives" published by the Center for Disease Control that will be mailed to the participant.
Tailored Print InterventionOther
Tailored Print Intervention: The tailored print intervention will consist of a cover letter detailing the participant's stage of readiness along with a color pamphlet with information personally tailored for the individual participant.
Tailored print plus tailored phone interventionOther
Tailored print plus tailored phone intervention: The tailored print plus tailored telephone intervention will consist of a phone counseling session and the tailored print information described above. The tailored print material will serve as a guide during the telephone counseling contact and a reinforcement of the information.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Generic Print Intervention: The generic print intervention will consist of the pamphlet, "Colorectal Cancer Screening Saves Lives" published by the Center for Disease Control that will be mailed to the participant. Receives: Other: Generic Print Intervention | |
| 2 | Tailored Print Intervention: The tailored print intervention will consist of a cover letter detailing the participant's stage of readiness along with a color pamphlet with information personally tailored for the individual participant. Receives: Other: Tailored Print Intervention | |
| 3 | Tailored print plus tailored phone intervention: The tailored print plus tailored telephone intervention will consist of a phone counseling session and the tailored print information described above. The tailored print material will serve as a guide during the telephone counseling contact and a reinforcement of the information. Receives: Other: Tailored print plus tailored phone intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phone follow-up interview. Participants will be contacted by study assistant and the survey administered.
Measured: 6 months after baseling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startJun 2003
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColorectalStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Fox Chase Cancer Center, Icahn School of Medicine at Mount Sinai, Lombardi Comprehensive Cancer Center, Micromass Communications, Cary, NC, University of Pennsylvania, Christiana Care Health Services, Pinnacle Health Regional Cancer Center, Harrisburg, PA, Temple University, St. Mary Regional Cancer Center, Langhorne, PA, South Jersey Regional Cancer Center, Bridgton, New Jersey, Hunterdon Cancer Center, Northeast Regional Cancer Institute, Virtua Memorial Hospital and Virtua West, Jersey Hospital, Rutgers Cancer Institute of New Jersey, Massachusetts General Hospital, Main Line Health, Roswell Park Cancer Institute, HematologyOncology, Associates of Central New York, Augusta University
- Investigators
- Arnold Markowitz, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582829
- Sponsor's protocol ID
- 03-043
- Status last verified
- Nov 2008
- First submitted
- 21 Dec 2007
- Last updated
- 7 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT00582829
- Acronym / sponsor ID
- 03-043
- Conditions
- Colorectal, Cancer, Screening, Intervention
- Keywords
- Colorectal, Cancer, Screening, Intervention, Family
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Fox Chase Cancer Center, Icahn School of Medicine at Mount Sinai, Lombardi Comprehensive Cancer Center, Micromass Communications, Cary, NC, University of Pennsylvania, Christiana Care Health Services, Pinnacle Health Regional Cancer Center, Harrisburg, PA, Temple University, St. Mary Regional Cancer Center, Langhorne, PA, South Jersey Regional Cancer Center, Bridgton, New Jersey, Hunterdon Cancer Center, Northeast Regional Cancer Institute, Virtua Memorial Hospital and Virtua West, Jersey Hospital, Rutgers Cancer Institute of New Jersey, Massachusetts General Hospital, Main Line Health, Roswell Park Cancer Institute, HematologyOncology, Associates of Central New York, Augusta University
- Study start
- Jun 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 28 Dec 2007 (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.
This proposed study will use previous study results to guide the development and evaluation of interventions to improve CRC screening acceptance. The proposed study will evaluate the impact of three interventions to promote CRC screening among siblings in this increased-risk group, who are not currently compliant with CRC screening guidelines: 1) a generic print intervention; 2) a tailored print intervention, and; 3) a tailored print plus tailored telephone counseling intervention.
Detailed description
First-degree relatives of individuals with CRC are at increased-risk of developing colorectal cancer (CRC). For these increased-risk individuals current guidelines recommend initiating CRC screening a decade earlier than for those at average-risk for CRC; thus, starting at age 40, or 10 years younger than the age at which the affected relative was diagnosed with CRC. In our prior study of 504 at-risk siblings of patients with a history of CRC, diagnosed at age less than 56, we found that approximately 44% of these siblings were not compliant with CRC screening guidelines. Guided by the Transtheoretical, Health Belief and Dual Process models, our prior study identified key attitudinal and non-attitudinal predictors of screening behaviors and intentions.
This proposed study will use these results to guide the development and evaluation of interventions to improve CRC screening acceptance. The proposed study will evaluate the impact of three interventions to promote CRC screening among siblings in this increased-risk group, who are not currently compliant with CRC screening guidelines: 1) a generic print intervention; 2) a tailored print intervention, and; 3) a tailored print plus tailored telephone counseling intervention.
Siblings in the generic print condition will receive a pamphlet about colorectal cancer screening published by the Center for Disease Control. Siblings in the tailored print and telephone counseling conditions will receive messages tailored specifically to their responses on targeted attitudinal and non-attitudinal measures. Five hundred twenty four siblings meeting eligibility criteria will be randomly assigned to one of the three conditions after a baseline interview assessing CRC screening behaviors and attitudes, and it is anticipated that 427 siblings will complete the study. For siblings in the tailored conditions, baseline information will be utilized to design the tailored messages. After receiving the intervention information, participants will be interviewed again six months later regarding CRC screening behaviors and attitudes to assess the impact of the intervention.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Generic Print InterventionGeneric Print Intervention: The generic print intervention will consist of the pamphlet, "Colorectal Cancer Screening Saves Lives" published by the Center for Disease Control that will be mailed to the participant. |
| 2 | – | Other: Tailored Print InterventionTailored Print Intervention: The tailored print intervention will consist of a cover letter detailing the participant's stage of readiness along with a color pamphlet with information personally tailored for the individual participant. |
| 3 | – | Other: Tailored print plus tailored phone interventionTailored print plus tailored phone intervention: The tailored print plus tailored telephone intervention will consist of a phone counseling session and the tailored print information described above. The tailored print material will serve as a guide during the telephone counseling contact and a reinforcement of the information. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- How old is the participant? (≥ 18 years)
- Is the participant either:
- currently age 40 or above (YES) OR
- within 10 years of the age at which the patient/proband was initially diagnosed with CRC (whichever is the younger age) (YES)
- Is the participant a full or half biological sibling of the patient/proband? (YES)
Key exclusion criteria (6 listed)
- Is the participant currently not compliant with standard CRC screening guidelines? (NO)
- Is the participant English speaking? (YES)
- Does the participant have a primary language other than English? (NO)
- Does the participant have a history of Inflammatory Bowel Disease? (NO)
- Does the participant have a history of colorectal cancer of colorectal polyp? (NO)
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 |
|---|---|---|
| Generic Print InterventionGeneric Print Intervention: The generic print intervention will consist of the pamphlet, "Colorectal Cancer Screening Saves Lives" published by the Center for Disease Control that will be mailed to the participant. | Other | 1 |
| Tailored Print InterventionTailored Print Intervention: The tailored print intervention will consist of a cover letter detailing the participant's stage of readiness along with a color pamphlet with information personally tailored for the individual participant. | Other | 2 |
| Tailored print plus tailored phone interventionTailored print plus tailored phone intervention: The tailored print plus tailored telephone intervention will consist of a phone counseling session and the tailored print information described above. The tailored print material will serve as a guide during the telephone counseling contact and a reinforcement of the information. | Other | 3 |
Primary outcome
Phone follow-up interview. Participants will be contacted by study assistant and the survey administered.
Time frame: 6 months after baseling
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 7 Nov 2008.
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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.
Arnold Markowitz, MD principal investigator
Memorial Sloan Kettering 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 and Cancer, run by Memorial Sloan Kettering 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 5 inclusion and 6 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 7 Nov 2008. 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?
Phone follow-up interview. Participants will be contacted by study assistant and the survey administered. (time frame: 6 months after baseling). 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 7 Nov 2008.