NCT04269837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 20, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2023

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

1.9 years

First QC Date

February 12, 2020

Last Update Submit

May 7, 2024

Conditions

Malignant Female Reproductive System NeoplasmStage I Cervical Cancer AJCC v8Stage I Uterine Corpus Cancer AJCC v8Stage I Vaginal Cancer AJCC v8Stage I Vulvar Cancer AJCC v8Stage IA Cervical Cancer AJCC v8Stage IA Uterine Corpus Cancer AJCC v8Stage IA Vaginal Cancer AJCC v8Stage IA Vulvar Cancer AJCC v8Stage IA1 Cervical Cancer AJCC v8Stage IA2 Cervical Cancer AJCC v8Stage IB Cervical Cancer AJCC v8Stage IB Uterine Corpus Cancer AJCC v8Stage IB Vaginal Cancer AJCC v8Stage IB Vulvar Cancer AJCC v8Stage IB1 Cervical Cancer AJCC v8Stage IB2 Cervical Cancer AJCC v8Stage II Cervical Cancer AJCC v8Stage II Uterine Corpus Cancer AJCC v8Stage II Vaginal Cancer AJCC v8Stage II Vulvar Cancer AJCC v8Stage IIA Cervical Cancer AJCC v8Stage IIA Vaginal Cancer AJCC v8Stage IIA1 Cervical Cancer AJCC v8Stage IIA2 Cervical Cancer AJCC v8Stage IIB Cervical Cancer AJCC v8Stage IIB Vaginal Cancer AJCC v8Stage III Cervical Cancer AJCC v8Stage III Uterine Corpus Cancer AJCC v8Stage III Vaginal Cancer AJCC v8Stage III Vulvar Cancer AJCC v8Stage IIIA Cervical Cancer AJCC v8Stage IIIA Uterine Corpus Cancer AJCC v8Stage IIIA Vulvar Cancer AJCC v8Stage IIIB Cervical Cancer AJCC v8Stage IIIB Uterine Corpus Cancer AJCC v8Stage IIIB Vulvar Cancer AJCC v8Stage IIIC Uterine Corpus Cancer AJCC v8Stage IIIC Vulvar Cancer AJCC v8Stage IIIC1 Uterine Corpus Cancer AJCC v8Stage IIIC2 Uterine Corpus Cancer AJCC v8Stage IVA Cervical Cancer AJCC v8Stage IVA Uterine Corpus Cancer AJCC v8Stage IVA Vaginal Cancer AJCC v8Stage IVA Vulvar Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

  • Overall completion

    Patients' characteristics and responses to the questionnaires will be summarized using appropriate summary statistics based on their distributions. Parametric tests such as the student's t test and Chi-square test or nonparametric tests such as Mann-Whitney U test and Fisher's exact test will be used to compare patients' characteristics between patients who completed the program and those who did not.

    Up to 6 months post radiation

  • Individual completion of the counseling sessions and questionnaires

    Patients' characteristics and responses to the questionnaires will be summarized using appropriate summary statistics based on their distributions. Parametric tests such as the student's t test and Chi-square test or nonparametric tests such as Mann-Whitney U test and Fisher's exact test will be used to compare patients' characteristics between patients who completed the program and those who did not.

    Up to 6 months post radiation

Secondary Outcomes (4)

  • Quality of life (QoL)

    Up to 6 months post radiation

  • Sexual function

    Up to 6 months post radiation

  • Genitourinary symptoms using Vaginal Heal Assessment (VHA)

    Up to 6 months post radiation

  • Genitourinary symptoms using Vaginal Assessment Scale (VAS)

    Up to 6 months post radiation

Study Arms (1)

Supportive Care (sexual health counseling)

EXPERIMENTAL

Patients receive sexual health counseling prior to starting and at the completion of radiation.

Other: CounselingOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

CounselingOTHER

Receive sexual health counseling

Also known as: Counseling Intervention
Supportive Care (sexual health counseling)
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Supportive Care (sexual health counseling)
Questionnaire AdministrationOTHER

Ancillary studies

Supportive Care (sexual health counseling)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Uterine Cervical NeoplasmsVaginal NeoplasmsVulvar Neoplasms

Interventions

Counseling

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesVaginal DiseasesVulvar Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Allison M Quick, MD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 17, 2020

Study Start

May 20, 2021

Primary Completion

April 6, 2023

Study Completion

April 6, 2023

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)