Cervical CancerNCT00788216
Development & Validation of Utilities for Health States Relevant to Cervical Cancer Patients
An observational study of Cervical Cancer, run by Duke University at 1 site in United States.
Trial summary
Purposes of this study: 1) To define comprehensive set of descriptive health states related to treatment of cervical cancer (e.g. radical hysterectomy, whole pelvic radiation, brachytherapy, chemoradiation) 2) To define set of descriptive health states related to adverse events associated w treatment of cervical… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Discussion & scoring of health states related to the treatment of cervical cancer
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Members of the Public- Members of the public are considered the standard group to assign utilities for health-economic purposes. Forty-five members of the public, without a diagnosis of cervical cancer, will be recruited. Cervical Cancer Patients- Fifteen patients, with a diagnosis of cervical cancer (either currently being treated or previously treated).
Who may be able to join
- Any member of public over age of 18 and without the diagnosis of cervical cancer can participate in this study.
- Patients over the age of 18 with the diagnosis of cervical cancer are eligible to participate in this study.
Who cannot join
- Any member of public under the age of 18 or with a prior diagnosis of cervical cancer is excluded from this study.
- Any cervical cancer patient younger than 18 is excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Development and Validation of A Comprehensive Instrument to Determine Utilities for Health States Relevant to Cervical Gynecologic Cancer Patients
Purposes of this study: 1) To define comprehensive set of descriptive health states related to treatment of cervical cancer (e.g. radical hysterectomy, whole pelvic radiation, brachytherapy, chemoradiation) 2) To define set of descriptive health states related to adverse events associated w treatment of cervical cancer (i.e. bladder dysfunction, pain, enteritis, fistula formation) \& 3) To derive, using a validated method, a set of QoL related utility scores corresponding to these health states.
Read the detailed description
Subjects will valuate cervical cancer-related health states using the visual analog score (VAS) and TTO (TTO) methods. The subject will be asked to read a pertinent health state description and listen while it is read aloud. She will first be asked to place the state on a continuum (VAS) from zero to 100, with 100 presenting perfect health and zero presenting death. The TTO interview will then be administered. The subject will be asked to assume a remaining life expectancy of 30 years, and to choose between 30 years in the health state described or 29 years in a state of perfect health. The utility of the health state, a number between zero and one, is calculated as the minimum number of years the patient would accept divided by 30. Each subject will be asked to review and valuate 20 health states over the course of 60-90 minutes.
- Conditions
- Cervical Cancer
- Being tested
- Discussion & scoring of health states related to the treatment of cervical cancer
- Keywords
- Radical hysterectomy, Whole pelvic radiation, Brachytherapy, Chemoradiation, Complications, Quality of Life
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discussion & scoring of health states related to the treatment of cervical cancerOther
Also called Ultities Scores
Subjects will be interviewed using the visual analog score and time trade off methods.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Women over the age of 18 without the diagnosis of cervical cancer. Receives: Other: Discussion & scoring of health states related to the treatment of cervical cancer | |
| Cervical Cancer Patients | Women over the age of 18 with a history of cervical cancer treated with surgery or chemoradiation. Receives: Other: Discussion & scoring of health states related to the treatment of cervical cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The development and validation of a comprehensive set of quality of life related utility scores for the treatment of cervical cancer.
Measured: lifetime
Secondary outcomes (1)
To incorporate these utility scores into a previous decision model which will allow for outcomes, costs, and quality of life to be analyzed in the treatment of cervical cancer patients.
Measured: lifetime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2009
- Study completionJun 2013
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 Duke 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
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura J Havrilesky, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788216
- Sponsor's protocol ID
- Pro00008129
- Status last verified
- Jul 2013
- First submitted
- 6 Nov 2008
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of A Comprehensive Instrument to Determine Utilities for Health States Relevant to Cervical Gynecologic Cancer Patients
- ClinicalTrials.gov ID
- NCT00788216
- Acronym / sponsor ID
- Pro00008129
- Conditions
- Cervical Cancer
- Keywords
- Radical hysterectomy, Whole pelvic radiation, Brachytherapy, Chemoradiation, Complications, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 10 Nov 2008 (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.
Purposes of this study: 1) To define comprehensive set of descriptive health states related to treatment of cervical cancer (e.g. radical hysterectomy, whole pelvic radiation, brachytherapy, chemoradiation) 2) To define set of descriptive health states related to adverse events associated w treatment of cervical cancer (i.e. bladder dysfunction, pain, enteritis, fistula formation) \& 3) To derive, using a validated method, a set of QoL related utility scores corresponding to these health states.
Detailed description
Subjects will valuate cervical cancer-related health states using the visual analog score (VAS) and TTO (TTO) methods. The subject will be asked to read a pertinent health state description and listen while it is read aloud. She will first be asked to place the state on a continuum (VAS) from zero to 100, with 100 presenting perfect health and zero presenting death. The TTO interview will then be administered. The subject will be asked to assume a remaining life expectancy of 30 years, and to choose between 30 years in the health state described or 29 years in a state of perfect health. The utility of the health state, a number between zero and one, is calculated as the minimum number of years the patient would accept divided by 30. Each subject will be asked to review and valuate 20 health states over the course of 60-90 minutes.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Other: Discussion & scoring of health states related to the treatment of cervical cancerWomen over the age of 18 without the diagnosis of cervical cancer. |
| Cervical Cancer Patients | – | Other: Discussion & scoring of health states related to the treatment of cervical cancerWomen over the age of 18 with a history of cervical cancer treated with surgery or chemoradiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Members of the Public- Members of the public are considered the standard group to assign utilities for health-economic purposes. Forty-five members of the public, without a diagnosis of cervical cancer, will be recruited. Cervical Cancer Patients- Fifteen patients, with a diagnosis of cervical cancer (either currently being treated or previously treated).
Key inclusion criteria (2 listed)
- Any member of public over age of 18 and without the diagnosis of cervical cancer can participate in this study.
- Patients over the age of 18 with the diagnosis of cervical cancer are eligible to participate in this study.
Key exclusion criteria (2 listed)
- Any member of public under the age of 18 or with a prior diagnosis of cervical cancer is excluded from this study.
- Any cervical cancer patient younger than 18 is excluded from this study.
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 |
|---|---|---|
| Discussion & scoring of health states related to the treatment of cervical cancerAlso: Ultities ScoresSubjects will be interviewed using the visual analog score and time trade off methods. | Other | Cervical Cancer Patients, Healthy Volunteers |
Primary outcome
The development and validation of a comprehensive set of quality of life related utility scores for the treatment of cervical cancer.
Time frame: lifetime
1 secondary outcome
To incorporate these utility scores into a previous decision model which will allow for outcomes, costs, and quality of life to be analyzed in the treatment of cervical cancer patients.
Time frame: lifetime
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2013.
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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.
Laura J Havrilesky, MD principal investigator
Duke 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 Cervical Cancer, run by Duke 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 2 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: finished, as of the sponsor's last update on 15 Jul 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The development and validation of a comprehensive set of quality of life related utility scores for the treatment of cervical cancer. (time frame: lifetime). 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 15 Jul 2013.