Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352638
Status:
COMPLETED
Last Update Posted:
2014-05-16
First Post:
2006-07-13
Brief Title:
Educational Intervention With or Without Telephone Counseling in Increasing Colorectal Cancer Screening Compliance in Brothers and Sisters of Patients With Colorectal Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Colorectal Cancer Screening Intervention for Family Members of Colorectal Cancer Patients
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 eg 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 andor 1 year
PROJECTED ACCRUAL A total of 660 participants will be accrued for this study
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 eg 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 andor 1 year
PROJECTED ACCRUAL A total of 660 participants will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FCCC-00-841 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000485294 | REGISTRY | None | None |