Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-12 @ 10:54 AM
Study NCT ID:
NCT01764802
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2013-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Psychosexual Intervention for Gynecologic and Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2018-05
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:
This randomized phase II trial studies how well psychosexual intervention works in patients with stage I-III gynecologic or breast cancer. Psychosexual intervention may improve sexual and psychosocial function.
Detailed Description:
PRIMARY OBJECTIVES:
I. Efficacy for reducing the severity of sexual distress, difficulty, and dysfunction in a phase II randomized clinical trial (RCT).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (Enhanced standard care): Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding gynecologic or breast cancer treatments and sexuality, and provision of a survivorship care plan (SCP) created using OncoLink over 1 hour following baseline assessment and before 6 months.
ARM II (Psychological intervention): Patients participate in individual or group therapy over 1.5 hours weekly for 4 weeks, bi-weekly for 8 weeks, and monthly for 2 months and complete assessment interviews.
After completion of study treatment, patients are followed up at 3, 6, and 9 months.
I. Efficacy for reducing the severity of sexual distress, difficulty, and dysfunction in a phase II randomized clinical trial (RCT).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (Enhanced standard care): Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding gynecologic or breast cancer treatments and sexuality, and provision of a survivorship care plan (SCP) created using OncoLink over 1 hour following baseline assessment and before 6 months.
ARM II (Psychological intervention): Patients participate in individual or group therapy over 1.5 hours weekly for 4 weeks, bi-weekly for 8 weeks, and monthly for 2 months and complete assessment interviews.
After completion of study treatment, patients are followed up at 3, 6, and 9 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-01341 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 1R21CA149675-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |