Overcoming Obstacles to Clinical Trials Enrollment Through a Navigator Program

Breast Cancer Clinical Trial

Official title:

Overcoming Obstacles to Clinical Trials Enrollment Through a Navigator Program

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01032447
• Other study ID #: GYN0001
• Secondary ID: GYN0001SU-102620
• Status: Terminated
• Phase: N/A
• First received: December 11, 2009
• Last updated: September 26, 2016
• Start date: January 2010
• Est. completion date: July 2013

Study information

• Verified date: September 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: July 2013
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Genital Neoplasms, Female
• Gynecologic Cancers

Intervention

Behavioral:
• Navigator Support
Standard of Care

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of the program		one year	No