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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Genital Neoplasms, Female
  • 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
  • Uterine Cervical Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms

NCT number NCT04269837
Study type Interventional
Source Ohio State University Comprehensive Cancer Center
Contact
Status Completed
Phase N/A
Start date May 20, 2021
Completion date April 6, 2023

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