Overcoming Obstacles to Clinical Trials Enrollment Throug... | NCT01032447

Studies
Overcoming Obstacles to Clinical Trials Enrollment Through a Navigator Program

NCT01032447

Sponsor

Stanford University

Status

Terminated

Last Update Posted

Sep 28, 2016Estimated

Enrollment

45Actual

Phase

Not provided

Conditions

Genital Neoplasms, Female
Gynecologic Cancers
Breast Cancer

Interventions

Navigator Support

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
GYN0001	Other Identifier	Stanford University
SU-10262009-4240	Other Identifier	Stanford

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Jul 2013Actual

First Submitted Date

Dec 11, 2009

First Submission Date that Met QC Criteria

Dec 11, 2009

First Posted Date

Dec 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2016

Last Update Posted Date

Sep 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Name	Type	Description	Arm Group Labels	Other Names
Navigator Support	Behavioral	Standard of Care		ULACC Navigator Training Program

Measure	Description	Time Frame
feasibility of the program		one year

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

ID	Term
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005831	Genital Diseases, Female

ID	Term
D005833	Genital Neoplasms, Female
D001943	Breast Neoplasms