Cancer Center Trials: Reasons for Low Accrual Rates at One Academic Institution Vs. The Community Setting

Cancer Clinical Trial

Official title:

Cancer Center Trials: Reasons for Low Accrual Rates at One Academic Institution Vs. The Community Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322647
• Other study ID #: 4904C
• Status: Completed
• Phase: N/A
• First received: May 5, 2006
• Last updated: January 6, 2010
• Start date: January 2005
• Est. completion date: June 2007

Study information

• Verified date: April 2008
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Not specified.

Study Design

Observational Model: Ecologic or Community, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States,