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Sexual Health Counseling Intervention During Radiation Therapy in Improving Quality of Life for Women With Gynecologic Cancer

The Ohio State University logo

The Ohio State University

Status

Completed

Conditions

Stage IIB Vaginal Cancer AJCC v8
Malignant Female Reproductive System Neoplasm
Stage IA2 Cervical Cancer AJCC v8
Stage IB Vulvar Cancer AJCC v8
Stage IA Vulvar Cancer AJCC v8
Stage IA Cervical Cancer AJCC v8
Stage II Vaginal Cancer AJCC v8
Stage I Vaginal Cancer AJCC v8
Stage IVA Vulvar Cancer AJCC v8
Stage IIIC Uterine Corpus Cancer AJCC v8
Stage II Uterine Corpus Cancer AJCC v8
Stage IVA Uterine Corpus Cancer AJCC v8
Stage IA Vaginal Cancer AJCC v8
Stage I Cervical Cancer AJCC v8
Stage IIA Cervical Cancer AJCC v8
Stage IIIB Cervical Cancer AJCC v8
Stage IIA1 Cervical Cancer AJCC v8
Stage IB1 Cervical Cancer AJCC v8
Stage II Cervical Cancer AJCC v8
Stage IA Uterine Corpus Cancer AJCC v8
Stage IB Cervical Cancer AJCC v8
Stage IIIC2 Uterine Corpus Cancer AJCC v8
Stage I Vulvar Cancer AJCC v8
Stage III Vaginal Cancer AJCC v8
Stage IB Uterine Corpus Cancer AJCC v8
Stage IIIA Vulvar Cancer AJCC v8
Stage IA1 Cervical Cancer AJCC v8
Stage IIIA Cervical Cancer AJCC v8
Stage IIIC1 Uterine Corpus Cancer AJCC v8
Stage III Uterine Corpus Cancer AJCC v8
Stage III Cervical Cancer AJCC v8
Stage III Vulvar Cancer AJCC v8
Stage IIIC Vulvar Cancer AJCC v8
Stage IIIB Vulvar Cancer AJCC v8
Stage IIIB Uterine Corpus Cancer AJCC v8
Stage IIA2 Cervical Cancer AJCC v8
Stage IB Vaginal Cancer AJCC v8
Stage IVA Vaginal Cancer AJCC v8
Stage IIIA Uterine Corpus Cancer AJCC v8
Stage II Vulvar Cancer AJCC v8
Stage IB2 Cervical Cancer AJCC v8
Stage I Uterine Corpus Cancer AJCC v8
Stage IVA Cervical Cancer AJCC v8
Stage IIB Cervical Cancer AJCC v8
Stage IIA Vaginal Cancer AJCC v8

Treatments

Other: Questionnaire Administration
Other: Quality-of-Life Assessment
Other: Counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT04269837
OSU-19322
NCI-2020-00135 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Any patient with endometrial, cervical, vaginal, or vulvar cancer receiving adjuvant external beam radiation or definitive external beam radiation and brachytherapy will be eligible for the study
  • Those receiving concurrent chemotherapy will be eligible
  • Any prior gynecologic surgery is permitted

Exclusion criteria

  • Patients with metastatic or recurrent disease and patients receiving brachytherapy alone

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

4 participants in 1 patient group

Supportive Care (sexual health counseling)
Experimental group
Description:
Patients receive sexual health counseling prior to starting and at the completion of radiation.
Treatment:
Other: Counseling
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Ohio State University Comprehensive Cancer Center

Data sourced from clinicaltrials.gov

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