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Overcoming Obstacles to Clinical Trials Enrollment Through a Navigator Program

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01032447
First received: December 11, 2009
Last updated: June 24, 2011
Last verified: June 2011
History of Changes
  Purpose

Pilot study for assessing the effectiveness of a Navigator program to aid in clinical trial participation amongst the Chinese demographic


Condition Intervention
Genital Neoplasms, Female
Gynecologic Cancers
Breast Cancer
 Behavioral: Navigator Support

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Overcoming Obstacles to Clinical Trials Enrollment Through a Navigator Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • feasibility of the program [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: January 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Navigator Support
    Standard of Care
    Other Name: ULACC Navigator Training Program
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

diagnosis of any gynecologic or breast cancer and be pursuing treatment here at Stanford within the last 2 years

Criteria

Inclusion Criteria:

Cancer patients for Focus Group must meet the following criterion:

  • diagnosis of any gynecologic or breast cancer and be pursuing treatment here at Stanford within the last 2 years
  • must read and speak Chinese
  • willing and able to participant in group discussions

Cancer patients to receive Navigator Support must meet the following criterion:

  • Newly diagnosed with gynecologic or breast cancer -pursuing treatment at Stanford Cancer Center
  • must read and speak Chinese
  • willing and able to have an individual relationship with a Navigator

Health Professional must meet the following criterion:

-must currently work in the Stanford gynecologic Oncology Clinic

Navigators must meet the following criterion:

  • Chinese and English speaking
  • willing and able to participate in training and to serve as a Navigator
  • preferably a Cancer survivor

Exclusion Criteria:

Cancer patients must have a GOG performance status of 0-2 (see attached document for further details). Focus Group participate MAY be able to be participating in another study but patients who are already participating in a clinical trial will not be assigned a Navigator.

No Exclusionary criterion for Health Professionals or Navigators.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032447

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Nelson N Teng Stanford University
  More Information

No publications provided

Responsible Party: Nelson N Teng, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01032447     History of Changes
Other Study ID Numbers: SU-10262009-4240, GYN0001
Study First Received: December 11, 2009
Last Updated: June 24, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Genital Neoplasms, Female
Neoplasms by Site
 Breast Diseases
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013