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

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

Study Overview

• Status: Completed
• Conditions: Cancer

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

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87114
      • University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Patients with cancer.

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: University of New Mexico
• Investigators: Principal Investigator: Claire Verschraegen, MD, University of New Mexico

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: May 5, 2006
• First Submitted That Met QC Criteria: May 5, 2006
• First Posted (Estimate): May 8, 2006

Study Record Updates

• Last Update Posted (Estimate): January 7, 2010
• Last Update Submitted That Met QC Criteria: January 6, 2010
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Other Study ID Numbers: 4904C