Colorectal CancerNCT00478309
Genetic Epidemiology Risk Assessment Program or Usual Care in Colorectal Cancer Screening for Healthy Participants
A study testing counseling intervention and educational intervention in people with Colorectal Cancer and Healthy, no Evidence of Disease, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
RATIONALE: The Genetic Epidemiology and Risk Assessment program may be more effective than usual care in increasing the number of healthy participants who regularly receive screening for colorectal cancer. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Healthy, no Evidence of Disease
- What is being tested?
- counseling intervention and educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 697 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Mar 2014
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Healthy participants meeting the following criteria:
- No personal history of colorectal polyps or cancer or inflammatory bowel disease
- No family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer (CRC), or CRC in more than 1 first-degree relative
- Nonadherent with standard CRC screening recommendations at the time of their index office visit
PATIENT CHARACTERISTICS:
- Able to communicate with ease in English
PRIOR CONCURRENT THERAPY:
- More than 6 weeks since prior antibiotics or antifolate medications (e.g., sulfasalazine, methotrexate)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
About this study
Official title: Gene Environment Risk Assessment and CRC Screening
RATIONALE: The Genetic Epidemiology and Risk Assessment program may be more effective than usual care in increasing the number of healthy participants who regularly receive screening for colorectal cancer.
PURPOSE: This randomized clinical trial is studying the Genetic Epidemiology and Risk Assessment program to see how well it works compared with usual care to increase colorectal cancer screening in healthy participants.
Read the detailed description
OBJECTIVES:
- Compare Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization by healthy participants.
- Determine the impact of GERA feedback and UC on psychological distress in these participants.
- Compare GERA feedback vs UC in terms of intention to have CRC screening, perceived CRC risk, CRC knowledge, salience and coherence of CRC screening, and support for CRC screening in these participants.
- Identify factors that moderate the impact of GERA feedback on CRC screening utilization.
OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 screening arms.
- Arm I: Participants receive standard primary care.
- Arm II: Participants receive standard primary care followed by the Genetic Epidemiology and Risk Assessment (GERA) intervention. Participants also participate in a discussion session regarding the GERA including the rationale behind methylenetetrahydrofolate reductase mutation detection and folate assessment and its relationship to colorectal cancer risk.
All participants undergo a fecal occult blood test 3 weeks after the screening office visit.
PROJECTED ACCRUAL: A total of 1,950 participants will be accrued for this study.
- Conditions
- Colorectal Cancer, Healthy, no Evidence of Disease
- Being tested
- counseling intervention, educational intervention
- Keywords
- colon cancer, rectal cancer, healthy, no evidence of disease
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling interventionOther
educational interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Arm I | No intervention | Participants receive standard primary care. |
| Arm II | Experimental | Participants receive standard primary care followed by the Genetic Epidemiology and Risk Assessment (GERA) intervention. Participants also participate in a discussion session regarding the GERA including the rationale behind methylenetetrahydrofolate reductase mutation detection and folate assessment and its relationship to colorectal cancer risk. Receives: Other: counseling intervention; Other: educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization
Measured: At study completion
Impact of GERA feedback and UC on psychological distress
Measured: At study completion
Comparison of GERA feedback vs UC in terms of intention to have CRC screening, perceived CRC risk, CRC knowledge, salience and coherence of CRC screening, and support for CRC screening
Measured: At study completion
Factors that moderate the impact of GERA feedback on CRC screening utilization
Measured: At study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 697 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Weinberg, MD, MSC, Study chair, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478309
- Sponsor's protocol ID
- CDR0000538405
- Other IDs
- IRB#06807
- Status last verified
- Mar 2016
- First submitted
- 23 May 2007
- Last updated
- 3 Mar 2016
- Results posted
- No
Publications
Myers RE, Manne SL, Wilfond B, Sifri R, Ziring B, Wolf TA, Cocroft J, Ueland A, Petrich A, Swan H, DiCarlo M, Weinberg DS. A randomized trial of genetic and environmental risk assessment (GERA) for colorectal cancer risk in primary care: trial design and baseline findings. Contemp Clin Trials. 2011 Jan;32(1):25-31. doi: 10.1016/j.cct.2010.08.013. Epub 2010 Sep 7.
PubMed 20828635
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Environment Risk Assessment and CRC Screening
- ClinicalTrials.gov ID
- NCT00478309
- Acronym / sponsor ID
- CDR0000538405
- Conditions
- Colorectal Cancer, Healthy, no Evidence of Disease
- Keywords
- colon cancer, rectal cancer, healthy, no evidence of disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 697 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2014 (actual)
- First posted
- 24 May 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.
RATIONALE: The Genetic Epidemiology and Risk Assessment program may be more effective than usual care in increasing the number of healthy participants who regularly receive screening for colorectal cancer.
PURPOSE: This randomized clinical trial is studying the Genetic Epidemiology and Risk Assessment program to see how well it works compared with usual care to increase colorectal cancer screening in healthy participants.
Detailed description
OBJECTIVES:
- Compare Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization by healthy participants.
- Determine the impact of GERA feedback and UC on psychological distress in these participants.
- Compare GERA feedback vs UC in terms of intention to have CRC screening, perceived CRC risk, CRC knowledge, salience and coherence of CRC screening, and support for CRC screening in these participants.
- Identify factors that moderate the impact of GERA feedback on CRC screening utilization.
OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 screening arms.
- Arm I: Participants receive standard primary care.
- Arm II: Participants receive standard primary care followed by the Genetic Epidemiology and Risk Assessment (GERA) intervention. Participants also participate in a discussion session regarding the GERA including the rationale behind methylenetetrahydrofolate reductase mutation detection and folate assessment and its relationship to colorectal cancer risk.
All participants undergo a fecal occult blood test 3 weeks after the screening office visit.
PROJECTED ACCRUAL: A total of 1,950 participants will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | No intervention | –Participants receive standard primary care. |
| Arm II | Experimental | Other: counseling intervention, Other: educational interventionParticipants receive standard primary care followed by the Genetic Epidemiology and Risk Assessment (GERA) intervention. Participants also participate in a discussion session regarding the GERA including the rationale behind methylenetetrahydrofolate reductase mutation detection and folate assessment and its relationship to colorectal cancer risk. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| counseling intervention | Other | Arm II |
| educational intervention | Other | Arm II |
Primary outcome
Comparison of Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization
Time frame: At study completion
Impact of GERA feedback and UC on psychological distress
Time frame: At study completion
Comparison of GERA feedback vs UC in terms of intention to have CRC screening, perceived CRC risk, CRC knowledge, salience and coherence of CRC screening, and support for CRC screening
Time frame: At study completion
Factors that moderate the impact of GERA feedback on CRC screening utilization
Time frame: At study completion
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 3 Mar 2016.
- Results publication: PubMed 20828635Myers RE, Manne SL, Wilfond B, Sifri R, Ziring B, Wolf TA, Cocroft J, Ueland A, Petrich A, Swan H, DiCarlo M, Weinberg DS. A randomized trial of genetic and environmental risk assessment (GERA) for colorectal cancer risk in primary care: trial design and baseline findings. Contemp Clin Trials. 2011 Jan;32(1):25-31. doi: 10.1016/j.cct.2010.08.013. Epub 2010 Sep 7.
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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 Weinberg, MD, MSC study chair
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling intervention and educational intervention in people with Colorectal Cancer and Healthy, no Evidence of Disease, run by Fox Chase 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?
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 3 Mar 2016. 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?
Comparison of Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization (time frame: At study completion). The study lists 4 primary outcomes in all. 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 NCT00478309, which also lists 1 linked publication.
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 3 Mar 2016.