Genital Neoplasms, FemaleNCT01032447
Overcoming Obstacles to Clinical Trials Enrollment Through a Navigator Program
An observational study of Genital Neoplasms, Female and Gynecologic Cancers, run by Stanford University at 1 site in United States.
Trial summary
Pilot study for assessing the effectiveness of a Navigator program to aid in clinical trial participation amongst the Chinese demographic Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genital Neoplasms, Female, Gynecologic Cancers, Breast Cancer
- What is being tested?
- Navigator Support
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: diagnosis of any gynecologic or breast cancer and be pursuing treatment here at Stanford within the last 2 years
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Pilot study for assessing the effectiveness of a Navigator program to aid in clinical trial participation amongst the Chinese demographic
- Being tested
- Navigator Support
- Medical subject headings
- Genital Neoplasms, Female, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigator SupportBehavioural
Also called ULACC Navigator Training Program
Standard of Care
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of the program
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital Neoplasms, FemaleStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelson N Teng, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032447
- Sponsor's protocol ID
- GYN0001
- Other IDs
- GYN0001, SU-10262009-4240
- Status last verified
- Sep 2016
- First submitted
- 11 Dec 2009
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Obstacles to Clinical Trials Enrollment Through a Navigator Program
- ClinicalTrials.gov ID
- NCT01032447
- Acronym / sponsor ID
- GYN0001
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot study for assessing the effectiveness of a Navigator program to aid in clinical trial participation amongst the Chinese demographic
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- diagnosis of any gynecologic or breast cancer and be pursuing treatment here at Stanford within the last 2 years
Key inclusion criteria (14 listed)
- 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
- Newly diagnosed with gynecologic or breast cancer -pursuing treatment at Stanford Cancer Center
- must read and speak Chinese
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigator SupportAlso: ULACC Navigator Training ProgramStandard of Care | Behavioural | – |
Primary outcome
feasibility of the program
Time frame: one year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelson N Teng principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genital Neoplasms, Female and Gynecologic Cancers, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of the program (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.