Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459238
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2007-04-09
Brief Title:
Telephone-Based Cancer Education With or Without Telephone-Based Counseling in Young Participants
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
A Telephone-Based Education and Prevention Intervention for Teens and Young Adults
Status:
COMPLETED
Status Verified Date:
2017-02
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 Telephone-based cancer education and counseling may help participants learn about ways of preventing cancer and choose a lifestyle that will help them stay healthy as they grow older
PURPOSE This randomized clinical trial is studying telephone-based cancer education and telephone-based counseling to see how well they work compared with telephone-based cancer education alone in young participants
PURPOSE This randomized clinical trial is studying telephone-based cancer education and telephone-based counseling to see how well they work compared with telephone-based cancer education alone in young participants
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of telephone-based cancer education with vs without counseling in younger participants
Secondary
Determine the mechanisms by which education with counseling may impact cancer-relevant cognitive and behavioral outcomes
Identify teens who may be most and least likely to benefit from education with counseling
OUTLINE This is a pilot controlled randomized study Participants are stratified according to age 13-14 years vs 15 years vs 16 years vs 17 years vs 18-21 years gender race white vs black vs other and health status chronic disease vs no chronic disease Participants are randomized to 1 of 2 education arms
Arm I Participants undergo cancer education sessions via telephone over 45 minutes once a week for 8 weeks
Arm II Participants under cancer education sessions as in arm I and counseling techniques during the same telephone sessions
In both arms participants receive an intervention kit by mail before the first telephone call The intervention kit includes age-appropriate self-help materials
PROJECTED ACCRUAL A total of 300 participants will be accrued for this study
Primary
Compare the efficacy of telephone-based cancer education with vs without counseling in younger participants
Secondary
Determine the mechanisms by which education with counseling may impact cancer-relevant cognitive and behavioral outcomes
Identify teens who may be most and least likely to benefit from education with counseling
OUTLINE This is a pilot controlled randomized study Participants are stratified according to age 13-14 years vs 15 years vs 16 years vs 17 years vs 18-21 years gender race white vs black vs other and health status chronic disease vs no chronic disease Participants are randomized to 1 of 2 education arms
Arm I Participants undergo cancer education sessions via telephone over 45 minutes once a week for 8 weeks
Arm II Participants under cancer education sessions as in arm I and counseling techniques during the same telephone sessions
In both arms participants receive an intervention kit by mail before the first telephone call The intervention kit includes age-appropriate self-help materials
PROJECTED ACCRUAL A total of 300 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 |
|---|---|---|---|
| GUMC-2006-243 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA051008 |
| R03CA119686 | NIH | None | None |
| P30CA051008 | NIH | None | None |