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

NCT ID: NCT00322647

Last Updated: 2010-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-06-30

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

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

Conditions

Cancer

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

University of New Mexico - CRTC

Principal Investigators

Claire Verschraegen, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

University of New Mexico

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

4904C

Identifier Type: -

Identifier Source: org_study_id