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Completed

NCT Number: NCT04269837

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

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.

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Key information

Conditions

Malignant Female Reproductive System Neoplasm Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site 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 Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Diseases Vaginal Neoplasms Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling

Other

Receive sexual health counseling

Other names: Counseling Intervention

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Overall completion

    Time frame: Up to 6 months post radiation

    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.

  2. Individual completion of the counseling sessions and questionnaires

    Time frame: Up to 6 months post radiation

    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.

Secondary outcomes

  1. Quality of life (QoL)

    Time frame: Up to 6 months post radiation

    Will be assesses using the European Organization for Research and Treatment of Cancer (EORTC) Core QoL Questionnaire (EORTC QLQ-C30). Data will be displayed graphically using boxplots, histograms and scatterplots to identify interesting features and potential outliers.

  2. Sexual function

    Time frame: Up to 6 months post radiation

    Will be assessed using the EORTC QLQ-CX24. Data will be displayed graphically using boxplots, histograms and scatterplots to identify interesting features and potential outliers.

  3. Genitourinary symptoms using Vaginal Heal Assessment (VHA)

    Time frame: Up to 6 months post radiation

    Will be assessed using the VHA. Data will be displayed graphically using boxplots, histograms and scatterplots to identify interesting features and potential outliers.The Vaginal Health Assessment, the examination tool used in the clinical validation of the VAS, will be utilized to for the gynecologic physical examination for all patients. 15 The assessment evaluates the physical aspect of the vagina including agglutination, adhesions, pH, dryness, rugosity, elasticity, length, thickness, epithelial integrity, vascularity, and irritation. Vaginal diameter will also be assessed during the manual portion of the exam.

    Estimates will be <2.5, 2.5, 3.0, 3.5, 4.0 or >4 cm. 16

  4. Genitourinary symptoms using Vaginal Assessment Scale (VAS)

    Time frame: Up to 6 months post radiation

    Will be assessed using the VAS. Data will be displayed graphically using boxplots, histograms and scatterplots to identify interesting features and potential outliers. Each item is scored from 0 (none) to 3 (severe) and a composite score is calculated by taking the mean of the items.

    A lower score indicates better function. In cancer patients and survivors, the scale were found to have high internal consistency.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Counseling Intervention During Radiation Therapy for Women With Gynecologic Cancer

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2020
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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