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

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ClinicalTrials.gov Identifier: NCT00322647
Recruitment Status : Completed
First Posted : May 8, 2006
Last Update Posted : January 7, 2010
Sponsor:
Information provided by:

Study Description
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

Condition or disease
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 Design

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Cancer Center Trials: Reasons for Low Accrual Rates at One Academic Institution Vs. The Community Setting
Study Start Date : January 2005
Study Completion Date : June 2007
Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with cancer.
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322647


Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87114
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Claire Verschraegen, MD University of New Mexico
More Information

Responsible Party: Claire Verschraegen, MD; Principal Investigator, University of New Mexico - CRTC
ClinicalTrials.gov Identifier: NCT00322647     History of Changes
Other Study ID Numbers: 4904C
First Posted: May 8, 2006    Key Record Dates
Last Update Posted: January 7, 2010
Last Verified: April 2008