Vaginal Changes and Sexual Function in Patients With Cerv... | NCT00053261

ID	Type	Description	Link
GOG-8003

Status Module

Record Verification Date

Jun 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

Jan 2007Actual

Completion Date

Not provided

First Submitted Date

Jan 27, 2003

First Submission Date that Met QC Criteria

Jan 27, 2003

First Posted Date

Jan 28, 2003Estimated

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

May 24, 2013

Last Update Posted Date

May 27, 2013Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
management of therapy complications	Procedure

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

69 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deborah Watkins Bruner, RN, PhD	Fox Chase Cancer Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center		Savannah	Georgia	31403	United States

ID	Term
D002583	Uterine Cervical Neoplasms
D019529	Sexuality

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases
D012725	Sexual Behavior
D001519	Behavior