Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322647
Status:
COMPLETED
Last Update Posted:
2010-01-07
First Post:
2006-05-05
Brief Title:
Cancer Center Trials Reasons for Low Accrual Rates at One Academic Institution Vs The Community Setting
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
Cancer Center Trials Reasons for Low Accrual Rates at One Academic Institution Vs The Community Setting
Status:
COMPLETED
Status Verified Date:
2008-04
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:
1 To identify reasons for low patient recruitment numbers to clinical trials in a cancer research center setting and a community setting in order to attempt to increase accrual rates
2 To review the screening sheet for women who considered participating in the study of Tamoxifen and Raloxifene STAR for the prevention of breast cancer in high risk women through the University of New Mexico in Albuquerque from 1999 through 2004
2 To review the screening sheet for women who considered participating in the study of Tamoxifen and Raloxifene STAR for the prevention of breast cancer in high risk women through the University of New Mexico in Albuquerque from 1999 through 2004
Detailed Description:
Objective 1 All new cancer patients seen for a four month period at the University of New Mexico Cancer Research and Treatment Center UNM CRTC academic population and for a six month-period at the New Mexico Cancer Care Alliance NMCCA community setting A careful screening log will be kept during this period with the research nurses cooperation in documenting 1 whether patients seen were accrued to a clinical trial 2 what available trials the patient might possibly be eligible for and 3 the reason for not registering on to a clinical trial
Objective 2 To compare the responses to questions on the entry forms of those women who were eligible and declined participation to those who participated by Hispanic versus non-Hispanic ethnicity we will access copy and analyze all the risk assessment profiles otherwise known as entry or eligibility forms completed by women who considered participating in the study of Tamoxifen and Raloxifene STAR Patterns of eligibility criteria and risk assessment will be described by ethnicity of women considered for entry into this chemopreventive randomized trial without the use of personal identifying data in accordance with the Health Insurance Portability Accountability Act of 1996 to maintain patient confidentiality
Objective 2 To compare the responses to questions on the entry forms of those women who were eligible and declined participation to those who participated by Hispanic versus non-Hispanic ethnicity we will access copy and analyze all the risk assessment profiles otherwise known as entry or eligibility forms completed by women who considered participating in the study of Tamoxifen and Raloxifene STAR Patterns of eligibility criteria and risk assessment will be described by ethnicity of women considered for entry into this chemopreventive randomized trial without the use of personal identifying data in accordance with the Health Insurance Portability Accountability Act of 1996 to maintain patient confidentiality
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