Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416975
Status:
COMPLETED
Last Update Posted:
2013-04-24
First Post:
2006-12-27
Brief Title:
Individualized Risk-Based Education in Promoting Breast Cancer Screening in Healthy Women
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Breast Cancer Risk-Tailored Messages for More Women
Status:
COMPLETED
Status Verified Date:
2013-04
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 Education based on a patients risk factors may help promote breast cancer screening in healthy women
PURPOSE This randomized clinical trial is studying individualized risk-based education to see how well it promotes breast cancer screening in healthy women compared to standard education
PURPOSE This randomized clinical trial is studying individualized risk-based education to see how well it promotes breast cancer screening in healthy women compared to standard education
Detailed Description:
OBJECTIVES
Primary
Compare the impact of risk-tailored messages vs standard health information on the outcome of mammography in healthy women
Secondary
Compare the effect of these interventions on breast self-examination clinical breast exam risk perceptions and breast cancer worry
Compare the mechanism of action of these interventions on participants by assessing the impact of covariants coping mechanisms expanded Health Belief Model variables breast cancer worry breast cancer risk factors including family history risk perceptions discussion of breast cancer with relatives previous screening practices intentions to screen and various demographic variables-age race and education on breast cancer screening
OUTLINE This is a randomized study
Participants are approached to complete a baseline survey while they are waiting for their clinic visits Baseline surveys measure breast cancer risk factors current breast cancer screening practices intentions to screen risk perceptions breast cancer worry coping mechanisms and discussion of breast cancer with relatives After completion of the baseline surveys participants are then randomized to 1 of 2 education arms
Arm I intervention group Participants undergo a computerized risk assessment followed by personalized risk-tailored health messages Health messages are based on principles of the expanded Health Belief Model HBM These messages include screening and lifestyle recommendations information on the seriousness of breast cancer instructions on how to arrange a mammography appointment and contact information for genetic and psychosocial counseling
Arm II control group Participants receive generalized breast health information sheets that contain appropriate screening and lifestyle recommendations for the general public and contact information for genetic and psychosocial counseling
All participants undergo follow-up assessment by telephone or by mail if unreachable by phone at 1 6 and 18 months after the initial intervention Self-reported mammography use additional breast health monitoring practices risk perception breast cancer worry coping mechanisms HBM-related beliefs and family communication are measured
PROJECTED ACCRUAL A total of 900 participants will be accrued for this study
Primary
Compare the impact of risk-tailored messages vs standard health information on the outcome of mammography in healthy women
Secondary
Compare the effect of these interventions on breast self-examination clinical breast exam risk perceptions and breast cancer worry
Compare the mechanism of action of these interventions on participants by assessing the impact of covariants coping mechanisms expanded Health Belief Model variables breast cancer worry breast cancer risk factors including family history risk perceptions discussion of breast cancer with relatives previous screening practices intentions to screen and various demographic variables-age race and education on breast cancer screening
OUTLINE This is a randomized study
Participants are approached to complete a baseline survey while they are waiting for their clinic visits Baseline surveys measure breast cancer risk factors current breast cancer screening practices intentions to screen risk perceptions breast cancer worry coping mechanisms and discussion of breast cancer with relatives After completion of the baseline surveys participants are then randomized to 1 of 2 education arms
Arm I intervention group Participants undergo a computerized risk assessment followed by personalized risk-tailored health messages Health messages are based on principles of the expanded Health Belief Model HBM These messages include screening and lifestyle recommendations information on the seriousness of breast cancer instructions on how to arrange a mammography appointment and contact information for genetic and psychosocial counseling
Arm II control group Participants receive generalized breast health information sheets that contain appropriate screening and lifestyle recommendations for the general public and contact information for genetic and psychosocial counseling
All participants undergo follow-up assessment by telephone or by mail if unreachable by phone at 1 6 and 18 months after the initial intervention Self-reported mammography use additional breast health monitoring practices risk perception breast cancer worry coping mechanisms HBM-related beliefs and family communication are measured
PROJECTED ACCRUAL A total of 900 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 |
|---|---|---|---|
| MCC-00036 | OTHER | Massey Cancer Center | httpsreporternihgovquickSearchP30CA016059 |
| P30CA016059 | NIH | None | None |