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Overcoming Obstacles to Clinical Trials Enrollment Through a Navigator Program

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01032447
First received: December 11, 2009
Last updated: June 24, 2011
Last verified: June 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Genital Neoplasms, Female
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014