Clinical trial NCT04269837: Sexual Health Counseling Intervention During Radiation Therapy in Improving Quality of Life for Women With Gynecologic Cancer
Official title: Counseling Intervention During Radiation Therapy for Women With Gynecologic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall completion
timeFrame: Up to 6 months post radiation
measure: Individual completion of the counseling sessions and questionnaires
timeFrame: Up to 6 months post radiation
Secondary outcomes:
measure: Quality of life (QoL)
timeFrame: Up to 6 months post radiation
measure: Sexual function
timeFrame: Up to 6 months post radiation
measure: Genitourinary symptoms using Vaginal Heal Assessment (VHA)
timeFrame: Up to 6 months post radiation
measure: Genitourinary symptoms using Vaginal Assessment Scale (VAS)
timeFrame: Up to 6 months post radiation
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Allison M Quick, MD
role: PRINCIPAL_INVESTIGATOR
References: