Overcoming Obstacles to Clinical Trials Enrollment Through a Navigator Program

• Sponsor: Stanford University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01032447
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Duration (Months): 42
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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	Phase
Genital Neoplasms, Female; Gynecologic Cancers; Breast Cancer	Behavioral: Navigator Support

Study Design

• 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: Jan 1, 2010
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jul 1, 2013

Outcome Measures

Primary Outcome Measures

1. feasibility of the program [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Nelson N Teng, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT01032447
• Other Study ID Numbers: GYN0001; GYN0001; SU-10262009-4240
• First Posted: Dec 15, 2009
• Last Update Posted: Sep 28, 2016
• Last Verified: Sep 1, 2016

• Additional relevant MeSH terms: Genital Neoplasms, Female

Study Results

No Results Posted as of Sep 28, 2016