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Overcoming Obstacles to Clinical Trials Enrollment Through a Navigator Program

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ClinicalTrials.gov Identifier: NCT01032447
Recruitment Status : Terminated
First Posted : December 15, 2009
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Stanford University

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

Condition or disease Intervention/treatment
Genital Neoplasms, Female Gynecologic Cancers Breast Cancer Behavioral: Navigator Support

Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Overcoming Obstacles to Clinical Trials Enrollment Through a Navigator Program
Study Start Date : January 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Behavioral: Navigator Support
    Standard of Care
    Other Name: ULACC Navigator Training Program


Primary Outcome Measures :
  1. feasibility of the program [ Time Frame: one year ]


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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:   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.


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): 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

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01032447     History of Changes
Other Study ID Numbers: GYN0001
GYN0001 ( Other Identifier: Stanford University )
SU-10262009-4240 ( Other Identifier: Stanford )
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016

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