Colorectal CancerPhase 3NCT00352638
Educational Intervention With or Without Telephone Counseling in Increasing Colorectal Cancer Screening Compliance in Brothers and Sisters of Patients With Colorectal Cancer
A Phase 3 study testing counseling intervention, educational intervention and study of socioeconomic and demographic variables in people with Colorectal Cancer, run by Fox Chase Cancer Center at 18 sites in United States.
Trial summary
RATIONALE: Printed educational materials and counseling by telephone may improve colorectal cancer screening compliance in brothers and sisters of patients with colorectal cancer. 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
- What is being tested?
- counseling intervention, educational intervention and study of socioeconomic and demographic variables
- How many people
- 660 participants
- Where
- 18 sitesUnited States
- Study dates
- Aug 2005to Nov 2013
- Phase
- Phase 3
- 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
DISEASE CHARACTERISTICS:
- Sibling of a patient diagnosed with adenocarcinoma of the colon or rectum
- Patient (proband) must meet the following criteria:
- Diagnosed in 1999 or later
- Currently living
- Seen in Community Clinical Oncology Program member hospital
- 60 and under at diagnosis
- No history of hereditary cancer syndrome (e.g., familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer) (patient and sibling)
- No history of colorectal cancer or colorectal polyps (sibling)
- No history of inflammatory bowel disease (patient and sibling)
PATIENT CHARACTERISTICS:
- Age 40 and over OR within 10 years of proband's (patient's) age at diagnosis
- English speaking
PRIOR CONCURRENT THERAPY:
- No prior colorectal cancer screening
- May have undergone prior screening provided they have not followed, or do not plan to follow, physician's recommendation for screening
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, 08822
PinnacleHealth Regional Cancer Center at Polyclinic Hospital
Harrisburg, Pennsylvania, 17105-8700
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
St. Mary Regional Cancer Center
Langhorne, Pennsylvania, 19047
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, 08053
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Helen F. Graham Cancer Center at Christiana Care
Newark, Delaware, 19713
Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
Fox Chase Cancer Center CCOP Research Base
Philadelphia, Pennsylvania, 19140
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, 19464
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
Northeast Regional Cancer Institute
Scranton, Pennsylvania, 18510
H. Lee Moffitt Cancer Center CCOP Research Base
Tampa, Florida, 33612
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland, New Jersey, 08360
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients
RATIONALE: Printed educational materials and counseling by telephone may improve colorectal cancer screening compliance in brothers and sisters of patients with colorectal cancer.
PURPOSE: This randomized phase III trial is studying standard or personalized printed educational materials with or without telephone counseling to compare how well they work in increasing colorectal cancer screening compliance in brothers and sisters of patients with colorectal cancer.
Read the detailed description
OBJECTIVES:
- Compare the impact of 3 interventions (generic educational print intervention, tailored educational print intervention, or tailored educational print intervention plus telephone counseling) on colorectal cancer screening behaviors and intentions among siblings at increased familial risk for colorectal cancer.
Secondary
- Determine whether demographic factors, medical access, physician recommendation at baseline, and proband (patient) characteristics (e.g., stage of disease) moderate the impact of the interventions on colorectal screening.
- Evaluate whether knowledge, attitude, and physician recommendation variables mediate the association between the interventions and colorectal screening, and determine whether these variables are impacted by the interventions.
- Analyze the cost of each intervention.
OUTLINE: This is a randomized, controlled, cohort, multicenter study. Participants are stratified according to study site. Participants are randomized to 1 of 3 intervention arms.
- Arm I: Participants receive generic educational print intervention approximately 1 week after completing the baseline survey.
- Arm II: Participants receive tailored educational print intervention within 10 days after completing the baseline survey and a tailored newsletter 1 month after completing the baseline survey.
- Arm III: Participants receive tailored educational print intervention approximately 14-18 days after completing the baseline survey. Participants undergo a telephone counseling session within 2 weeks after receiving the tailored print intervention and receive a tailored newsletter 1 month after completing the baseline survey.
After study completion, participants are followed at 6 months and/or 1 year.
PROJECTED ACCRUAL: A total of 660 participants will be accrued for this study.
- Conditions
- Colorectal Cancer
- Being tested
- counseling intervention, educational intervention, study of socioeconomic and demographic variables
- Keywords
- colon cancer, rectal cancer
- 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 of socioeconomic and demographic variablesOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer screening compliance
Secondary outcomes (3)
Impact on movement in stage of adoption
Increased knowledge and attitudes
Cost
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startAug 2005
- Primary completionFeb 2012
- Study completionNov 2013
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 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 3
- Allocation
- Randomised
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sharon Manne, PhD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352638
- Sponsor's protocol ID
- FCCC-FCRB-04-004-P
- Other IDs
- CDR0000485294, FCCC-00-841
- Status last verified
- May 2014
- First submitted
- 13 Jul 2006
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. 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
- NCT00352638
- Acronym / sponsor ID
- FCCC-FCRB-04-004-P
- Conditions
- Colorectal Cancer
- Keywords
- colon cancer, rectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2005
- Primary completion
- Feb 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 14 Jul 2006 (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: Printed educational materials and counseling by telephone may improve colorectal cancer screening compliance in brothers and sisters of patients with colorectal cancer.
PURPOSE: This randomized phase III trial is studying standard or personalized printed educational materials with or without telephone counseling to compare how well they work in increasing colorectal cancer screening compliance in brothers and sisters of patients with colorectal cancer.
Detailed description
OBJECTIVES:
- Compare the impact of 3 interventions (generic educational print intervention, tailored educational print intervention, or tailored educational print intervention plus telephone counseling) on colorectal cancer screening behaviors and intentions among siblings at increased familial risk for colorectal cancer.
Secondary
- Determine whether demographic factors, medical access, physician recommendation at baseline, and proband (patient) characteristics (e.g., stage of disease) moderate the impact of the interventions on colorectal screening.
- Evaluate whether knowledge, attitude, and physician recommendation variables mediate the association between the interventions and colorectal screening, and determine whether these variables are impacted by the interventions.
- Analyze the cost of each intervention.
OUTLINE: This is a randomized, controlled, cohort, multicenter study. Participants are stratified according to study site. Participants are randomized to 1 of 3 intervention arms.
- Arm I: Participants receive generic educational print intervention approximately 1 week after completing the baseline survey.
- Arm II: Participants receive tailored educational print intervention within 10 days after completing the baseline survey and a tailored newsletter 1 month after completing the baseline survey.
- Arm III: Participants receive tailored educational print intervention approximately 14-18 days after completing the baseline survey. Participants undergo a telephone counseling session within 2 weeks after receiving the tailored print intervention and receive a tailored newsletter 1 month after completing the baseline survey.
After study completion, participants are followed at 6 months and/or 1 year.
PROJECTED ACCRUAL: A total of 660 participants will be accrued for this study.
Study design
- Allocation
- Randomised
Who may qualify
- Ages
- 40 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 | – |
| educational intervention | Other | – |
| study of socioeconomic and demographic variables | Other | – |
Primary outcome
Colorectal cancer screening compliance
3 secondary outcomes
Impact on movement in stage of adoption
Increased knowledge and attitudes
Cost
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 16 May 2014.
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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.
Sharon Manne, PhD principal investigator
Fox Chase Cancer Center
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing counseling intervention, educational intervention and study of socioeconomic and demographic variables in people with Colorectal Cancer, run by Fox Chase Cancer Center at 18 sites 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 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Colorectal cancer screening compliance. 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 16 May 2014; AzTrials last refreshed its copy on 6 Nov 2026.