Cervical CancerNCT00519272
A Prospective Study Examining the Barriers to Care for Harris County Cervical Cancer Patients
An observational study of Cervical Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this behavioral research study is to look at the reasons that may prevent women from getting early treatment for their cervical cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2006to 15 May 2019
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with newly diagnosed cervical cancer or precancerous lesions (CIS) seen in the Gynecologic-Oncology or Colposcopy Clinic at Lyndon B. Johnson General Hospital in Houston, Texas.
Who may be able to join
- 1) All newly diagnosed cervical cancer patients through Stage IVB presenting to the Lyndon B. Johnson General Hospital (LBJ) Gynecologic Oncology Clinic.
Who cannot join
- 1) Patients who are not English or Spanish speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lyndon B. Johnson General Hospital
Houston, Texas, 77030
About this study
The goal of this behavioral research study is to look at the reasons that may prevent women from getting early treatment for their cervical cancer.
Read the detailed description
Little is known about what prevents women with cervical cancer from getting early and possibly curative treatment. This study consists of a series of questionnaires that ask questions about religion; coping; access to health care; physical, emotional, and spiritual well-being; understanding of health questions; control; fear; anxiety; and other health beliefs to determine why some women delay coming in for check-ups and why some women do not complete their treatments. It is thought that health beliefs influence behavior practices and that by identifying these issues, things can be done to improve the health condition and results for these patients.
You will be asked to complete a series of questionnaires at 2 specific time points: The first time point will be before treatment begins and the second time point will be within a month following completion of treatment.
Filling out the questionnaires should take about 45 minutes each time. You should have adequate time to complete these questionnaires during your clinic appointment.
If you want to take part but are too ill to complete the questionnaires, you will be provided a pre-addressed, stamped envelope, so that you can mail them back to the study staff at your earliest convenience.
This is an investigational study. This is an investigational study. Up to 150 patients will be enrolled at Lyndon B. Johnson General Hospital.
- Conditions
- Cervical Cancer
- Being tested
- Questionnaire
- Keywords
- Cervical Cancer, Cervix, Precancerous Lesions, Cervical carcinoma in situ, CIS, Early cervical cancer detection and treatment, Barriers to Care, Harris County, Questionnaire
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Series of surveys to be completed at the time of diagnosis and within one month after completion of treatment, taking approximately 45 minutes each time.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Cancer Care Questionnaires | New cervical cancer patients through stage IVB presenting to the LBJ Gyn-Onc Clinic. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Issues preventing access to early cervical cancer detection and treatment among Harris County cervical cancer patients.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study start21 Jul 2006
- Primary completion15 May 2019
- Study completion15 May 2019
Why it stopped: Requested by PI during yearly Continuing Review
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lois M. Ramondetta, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519272
- Sponsor's protocol ID
- 2006-0530
- Status last verified
- Dec 2019
- First submitted
- 20 Aug 2007
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Examining the Barriers to Care for Harris County Cervical Cancer Patients
- ClinicalTrials.gov ID
- NCT00519272
- Acronym / sponsor ID
- 2006-0530
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, Cervix, Precancerous Lesions, Cervical carcinoma in situ, CIS, Early cervical cancer detection and treatment, Barriers to Care, Harris County
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Requested by PI during yearly Continuing Review
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 21 Jul 2006 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 22 Aug 2007 (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.
The goal of this behavioral research study is to look at the reasons that may prevent women from getting early treatment for their cervical cancer.
Detailed description
Little is known about what prevents women with cervical cancer from getting early and possibly curative treatment. This study consists of a series of questionnaires that ask questions about religion; coping; access to health care; physical, emotional, and spiritual well-being; understanding of health questions; control; fear; anxiety; and other health beliefs to determine why some women delay coming in for check-ups and why some women do not complete their treatments. It is thought that health beliefs influence behavior practices and that by identifying these issues, things can be done to improve the health condition and results for these patients.
You will be asked to complete a series of questionnaires at 2 specific time points: The first time point will be before treatment begins and the second time point will be within a month following completion of treatment.
Filling out the questionnaires should take about 45 minutes each time. You should have adequate time to complete these questionnaires during your clinic appointment.
If you want to take part but are too ill to complete the questionnaires, you will be provided a pre-addressed, stamped envelope, so that you can mail them back to the study staff at your earliest convenience.
This is an investigational study. This is an investigational study. Up to 150 patients will be enrolled at Lyndon B. Johnson General Hospital.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical Cancer Care Questionnaires | – | Behavioral: QuestionnaireNew cervical cancer patients through stage IVB presenting to the LBJ Gyn-Onc Clinic. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with newly diagnosed cervical cancer or precancerous lesions (CIS) seen in the Gynecologic-Oncology or Colposcopy Clinic at Lyndon B. Johnson General Hospital in Houston, Texas.
Key inclusion criteria (1 listed)
- 1) All newly diagnosed cervical cancer patients through Stage IVB presenting to the Lyndon B. Johnson General Hospital (LBJ) Gynecologic Oncology Clinic.
Key exclusion criteria (1 listed)
- 1) Patients who are not English or Spanish speaking.
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 |
|---|---|---|
| QuestionnaireAlso: SurveySeries of surveys to be completed at the time of diagnosis and within one month after completion of treatment, taking approximately 45 minutes each time. | Behavioural | Cervical Cancer Care Questionnaires |
Primary outcome
Issues preventing access to early cervical cancer detection and treatment among Harris County cervical cancer patients.
Time frame: 3 Years
Results and safety
The study was stopped early (reason given: Requested by PI during yearly Continuing Review). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Lois M. Ramondetta, MD principal investigator
M.D. Anderson Cancer Center
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 Cervical Cancer, run by M.D. Anderson Cancer Center 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 1 inclusion and 1 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 2 Jan 2020. 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 (reason given: Requested by PI during yearly Continuing Review). 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?
Issues preventing access to early cervical cancer detection and treatment among Harris County cervical cancer patients. (time frame: 3 Years). 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 2 Jan 2020.