Cervical CancerNCT00053261
Vaginal Changes and Sexual Function in Patients With Cervical Cancer
An observational study of Cervical Cancer and Sexuality and Reproductive Issues, run by Gynecologic Oncology Group at 12 sites in United States.
Trial summary
RATIONALE: Vaginal changes that may effect sexual function occur in patients undergoing treatment for cervical cancer. PURPOSE: Clinical trial to determine the type of vaginal changes such as vaginal dryness that occur in patients receiving treatment for cervical cancer and the effect these changes have on sexual… Read more about this study
- Who is it for?
- Ages Up to 69 years, women only
- Conditions the study is for
- Cervical Cancer, Sexuality and Reproductive Issues
- What is being tested?
- management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 12 sitesUnited States
- Study dates
- Jul 2003to Jan 2007
- 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 Up to 69 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Entered and treated on GOG-0201 or eligible for and treated on either arm of GOG-0201
- May have refused entry on GOG-0201 as long as treatment is prescribed according to one or the other arm
PATIENT CHARACTERISTICS:
Age
- Under 70
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, 18105
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Borgess Medical Center
Kalamazooaa, Michigan, 49001
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, 31403
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, 11794
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, 74104
About this study
Official title: Vaginal Length, Elasticity, Lubrication And Sexual Function In Women With Stage IB2 Cervix Carcinoma
RATIONALE: Vaginal changes that may effect sexual function occur in patients undergoing treatment for cervical cancer.
PURPOSE: Clinical trial to determine the type of vaginal changes such as vaginal dryness that occur in patients receiving treatment for cervical cancer and the effect these changes have on sexual function.
Read the detailed description
OBJECTIVES:
- Obtain estimates of changes in vaginal length, perceived vaginal elasticity, perceived vaginal lubrication, and sexual activity, response, and satisfaction among patients with stage IB2 cervical cancer.
- Compare these differences between the patients in the two treatment groups in GOG-0201.
- Determine the relationships between vaginal dilation activities and vaginal length changes in these patients.
- Determine the association between smoking and vaginal length and between smoking and vaginal dryness in these patients after therapy for cervical cancer.
- Assess the extent of subject interest in and preferred methods of sexual counseling related to problems resulting from treatment in these patients.
OUTLINE: Vaginal length is measured using Vaginal Sound, a modified plastic vaginal dilator. The data about vaginal elasticity and lubrication and sexual activity, response, and satisfaction are obtained from patient self-report, as well as vaginal dilation activities. Measurement and assessments are taken before treatment and then at 3, 6, 12, and 24 months.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: Approximately 150 patients will be accrued for this study.
- Conditions
- Cervical Cancer, Sexuality and Reproductive Issues
- Being tested
- management of therapy complications
- Keywords
- sexuality and reproductive issues, stage IB cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
management of therapy complicationsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2003 (estimated)
- Study startJul 2003
- Primary completionJan 2007
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.
- 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
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Deborah Watkins Bruner, RN, PhD, Study chair, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053261
- Sponsor's protocol ID
- CDR0000269327
- Other IDs
- GOG-8003
- Status last verified
- Jun 2005
- First submitted
- 27 Jan 2003
- Last updated
- 27 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Length, Elasticity, Lubrication And Sexual Function In Women With Stage IB2 Cervix Carcinoma
- ClinicalTrials.gov ID
- NCT00053261
- Acronym / sponsor ID
- CDR0000269327
- Conditions
- Cervical Cancer, Sexuality and Reproductive Issues
- Keywords
- sexuality and reproductive issues, stage IB cervical cancer
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2003
- Primary completion
- Jan 2007 (actual)
- First posted
- 28 Jan 2003 (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.
RATIONALE: Vaginal changes that may effect sexual function occur in patients undergoing treatment for cervical cancer.
PURPOSE: Clinical trial to determine the type of vaginal changes such as vaginal dryness that occur in patients receiving treatment for cervical cancer and the effect these changes have on sexual function.
Detailed description
OBJECTIVES:
- Obtain estimates of changes in vaginal length, perceived vaginal elasticity, perceived vaginal lubrication, and sexual activity, response, and satisfaction among patients with stage IB2 cervical cancer.
- Compare these differences between the patients in the two treatment groups in GOG-0201.
- Determine the relationships between vaginal dilation activities and vaginal length changes in these patients.
- Determine the association between smoking and vaginal length and between smoking and vaginal dryness in these patients after therapy for cervical cancer.
- Assess the extent of subject interest in and preferred methods of sexual counseling related to problems resulting from treatment in these patients.
OUTLINE: Vaginal length is measured using Vaginal Sound, a modified plastic vaginal dilator. The data about vaginal elasticity and lubrication and sexual activity, response, and satisfaction are obtained from patient self-report, as well as vaginal dilation activities. Measurement and assessments are taken before treatment and then at 3, 6, 12, and 24 months.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: Approximately 150 patients will be accrued for this study.
Study design
Who may qualify
- Ages
- Up to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| management of therapy complications | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 27 May 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.
Deborah Watkins Bruner, RN, PhD study chair
Fox Chase Cancer Center
12 sites 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 and Sexuality and Reproductive Issues, run by Gynecologic Oncology Group at 12 sites 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?
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 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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.
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 27 May 2013.