Trials / Completed
CompletedNCT04269837
Sexual Health Counseling Intervention During Radiation Therapy in Improving Quality of Life for Women With Gynecologic Cancer
Counseling Intervention During Radiation Therapy for Women With Gynecologic Cancer
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Ohio State University Comprehensive Cancer Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase I trial studies a sexual health counseling intervention during radiation therapy in improving quality of life for women with gynecologic cancer. Women with gynecologic cancer often suffer long-term complications from treatment that can affect their physical and psychological well-being. An early sexual health counseling intervention prior to and after radiation may improve symptoms management and reduce the physical and psychological effects of treatment.
Detailed description
PRIMARY OBJECTIVE: I. To determine the feasibility of a sexual health counseling intervention before and after pelvic radiation for women with gynecologic cancers. SECONDARY OBJECTIVE: I. To preliminarily evaluate the efficacy of a sexual health counseling intervention on patient reported outcomes in quality of life, sexual function, and genitourinary symptoms. OUTLINE: Patients receive sexual health counseling prior to starting and at the completion of radiation. After completion of study, patients are followed up at 1 and 6 months after radiation.
Conditions
- Malignant Female Reproductive System Neoplasm
- Stage I Cervical Cancer AJCC v8
- Stage I Uterine Corpus Cancer AJCC v8
- Stage I Vaginal Cancer AJCC v8
- Stage I Vulvar Cancer AJCC v8
- Stage IA Cervical Cancer AJCC v8
- Stage IA Uterine Corpus Cancer AJCC v8
- Stage IA Vaginal Cancer AJCC v8
- Stage IA Vulvar Cancer AJCC v8
- Stage IA1 Cervical Cancer AJCC v8
- Stage IA2 Cervical Cancer AJCC v8
- Stage IB Cervical Cancer AJCC v8
- Stage IB Uterine Corpus Cancer AJCC v8
- Stage IB Vaginal Cancer AJCC v8
- Stage IB Vulvar Cancer AJCC v8
- Stage IB1 Cervical Cancer AJCC v8
- Stage IB2 Cervical Cancer AJCC v8
- Stage II Cervical Cancer AJCC v8
- Stage II Uterine Corpus Cancer AJCC v8
- Stage II Vaginal Cancer AJCC v8
- Stage II Vulvar Cancer AJCC v8
- Stage IIA Cervical Cancer AJCC v8
- Stage IIA Vaginal Cancer AJCC v8
- Stage IIA1 Cervical Cancer AJCC v8
- Stage IIA2 Cervical Cancer AJCC v8
- Stage IIB Cervical Cancer AJCC v8
- Stage IIB Vaginal Cancer AJCC v8
- Stage III Cervical Cancer AJCC v8
- Stage III Uterine Corpus Cancer AJCC v8
- Stage III Vaginal Cancer AJCC v8
- Stage III Vulvar Cancer AJCC v8
- Stage IIIA Cervical Cancer AJCC v8
- Stage IIIA Uterine Corpus Cancer AJCC v8
- Stage IIIA Vulvar Cancer AJCC v8
- Stage IIIB Cervical Cancer AJCC v8
- Stage IIIB Uterine Corpus Cancer AJCC v8
- Stage IIIB Vulvar Cancer AJCC v8
- Stage IIIC Uterine Corpus Cancer AJCC v8
- Stage IIIC Vulvar Cancer AJCC v8
- Stage IIIC1 Uterine Corpus Cancer AJCC v8
- Stage IIIC2 Uterine Corpus Cancer AJCC v8
- Stage IVA Cervical Cancer AJCC v8
- Stage IVA Uterine Corpus Cancer AJCC v8
- Stage IVA Vaginal Cancer AJCC v8
- Stage IVA Vulvar Cancer AJCC v8
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Counseling | Receive sexual health counseling |
| OTHER | Quality-of-Life Assessment | Ancillary studies |
| OTHER | Questionnaire Administration | Ancillary studies |
Timeline
- Start date
- 2021-05-20
- Primary completion
- 2023-04-06
- Completion
- 2023-04-06
- First posted
- 2020-02-17
- Last updated
- 2024-05-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04269837. Inclusion in this directory is not an endorsement.