Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053261
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
2003-01-27
Brief Title:
Vaginal Changes and Sexual Function in Patients With Cervical Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Vaginal Length Elasticity Lubrication And Sexual Function In Women With Stage IB2 Cervix Carcinoma
Status:
COMPLETED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-8003 | None | None | None |