Malignant Female Reproductive System NeoplasmNCT04269837
Sexual Health Counseling Intervention During Radiation Therapy in Improving Quality of Life for Women With Gynecologic Cancer
A study testing Counseling, Quality-of-Life Assessment and Questionnaire Administration in people with Malignant Female Reproductive System Neoplasm and Stage I Cervical Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Female Reproductive System Neoplasm, Stage I Cervical Cancer AJCC v8, Stage I Uterine Corpus Cancer AJCC v8
- What is being tested?
- Counseling, Quality-of-Life Assessment and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 6 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with metastatic or recurrent disease and patients receiving brachytherapy alone
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Counseling Intervention During Radiation Therapy 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of a sexual health counseling intervention before and after pelvic radiation for women with gynecologic cancers.
SECONDARY OBJECTIVE:
- 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.
- 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
- Being tested
- Counseling, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Uterine Cervical Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingOther
Also called Counseling Intervention
Receive sexual health counseling
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (sexual health counseling) | Experimental | Patients receive sexual health counseling prior to starting and at the completion of radiation. Receives: Other: Counseling; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 6 months post radiation
Secondary outcomes (4)
Quality of life (QoL)
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.
Measured: Up to 6 months post radiation
Sexual function
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.
Measured: Up to 6 months post radiation
Genitourinary symptoms using Vaginal Heal Assessment (VHA)
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
Measured: Up to 6 months post radiation
Genitourinary symptoms using Vaginal Assessment Scale (VAS)
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.
Measured: Up to 6 months post radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start20 May 2021
- Primary completion6 Apr 2023
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Female Reproductive System NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Quick, Ohio State University Comprehensive Cancer Center
- Investigators
- Allison M Quick, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269837
- Sponsor's protocol ID
- OSU-19322
- Other IDs
- NCI-2020-00135
- Status last verified
- May 2024
- First submitted
- 12 Feb 2020
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Counseling Intervention During Radiation Therapy for Women With Gynecologic Cancer
- ClinicalTrials.gov ID
- NCT04269837
- Acronym / sponsor ID
- OSU-19322
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the feasibility of a sexual health counseling intervention before and after pelvic radiation for women with gynecologic cancers.
SECONDARY OBJECTIVE:
- 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (sexual health counseling) | Experimental | Other: Counseling, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive sexual health counseling prior to starting and at the completion of radiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with metastatic or recurrent disease and patients receiving brachytherapy alone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounselingAlso: Counseling InterventionReceive sexual health counseling | Other | Supportive Care (sexual health counseling) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive Care (sexual health counseling) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (sexual health counseling) |
Primary outcome
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.
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.
4 secondary outcomes
Quality of life (QoL)
Time frame: Up to 6 months post radiation
Sexual function
Time frame: Up to 6 months post radiation
Genitourinary symptoms using Vaginal Heal Assessment (VHA)
Time frame: Up to 6 months post radiation
Genitourinary symptoms using Vaginal Assessment Scale (VAS)
Time frame: Up to 6 months post radiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Malignant Female Reproductive System Neoplasm
Active, not recruiting
A Nurse-Led Intervention for Fear of Progression in Advanced Cancer
Advanced Lung Carcinoma, Metastatic Malignant Female Reproductive System Neoplasm
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
RecruitingObservational study
Influencing Next-Generation Oncologic Outcomes Through Rapid Integration of Functional Precision Medicine (NOORI): A Feasibility Study of SmartMatch in Rare Gynecologic Cancers
Malignant Female Reproductive System Neoplasm, Metastatic Malignant Female Reproductive System Neoplasm
RecruitingPhase 2
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
Recruiting
An Individualized Online Home-Based Exercise Program for Improving Symptoms in Gynecologic Cancer Survivors
Malignant Female Reproductive System Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison M Quick, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling, Quality-of-Life Assessment and Questionnaire Administration in people with Malignant Female Reproductive System Neoplasm and Stage I Cervical Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall completion (time frame: Up to 6 months post radiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024; AzTrials last refreshed its copy on 26 Oct 2026.