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Sexual Health Counseling for Gynecologic Cancer
N/A
Recruiting
Led By Allison M Quick, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months post radiation
Awards & highlights
Study Summary
This trial looks at whether a sexual health counseling intervention can improve quality of life for women with gynecologic cancer.
Who is the study for?
This trial is for women with gynecologic cancers such as cervical, uterine corpus, vaginal, or vulvar cancer who are about to receive radiation therapy. It's open to those also getting chemotherapy and any prior surgery is okay. Women with metastatic or recurrent disease or receiving only brachytherapy can't participate.Check my eligibility
What is being tested?
The study tests a sexual health counseling intervention aimed at improving quality of life during radiation treatment for gynecologic cancer. The goal is to manage symptoms better and lessen the physical and psychological impacts of treatment.See study design
What are the potential side effects?
Since this trial focuses on counseling rather than medication, there may not be direct side effects like those seen with drugs. However, discussing sensitive topics could potentially cause emotional discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months post radiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months post radiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Individual completion of the counseling sessions and questionnaires
Overall completion
Secondary outcome measures
Genitourinary symptoms using Vaginal Assessment Scale (VAS)
Genitourinary symptoms using Vaginal Heal Assessment (VHA)
Quality of life (QoL)
+1 moreSide effects data
From 2022 Phase 3 trial • 87 Patients • NCT0206618173%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Blurred vision
2%
Acute kidney injury
2%
Hemorrhoids
2%
Hypothyroidism
2%
Urticaria
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group
Trial Design
1Treatment groups
Experimental Treatment
Group I: Supportive Care (sexual health counseling)Experimental Treatment3 Interventions
Patients receive sexual health counseling prior to starting and at the completion of radiation.
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,137 Total Patients Enrolled
Allison M Quick, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can participate in the trial even if you are currently receiving chemotherapy.You have cancer that has spread or come back, and you are not receiving a specific type of radiation treatment called brachytherapy alone.You are eligible for the study if you have endometrial, cervical, vaginal, or vulvar cancer and are receiving radiation therapy as part of your treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive Care (sexual health counseling)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still room to join this experiment?
"As confirmed by clinicaltrials.gov, this research endeavour is currently seeking participants with eligibility criteria outlined in their initial post on May 20th 2021 and revised most recently on February 25th 2022."
Answered by AI
What is the maximum enrollment capacity for this research program?
"Affirmative, the information available on clinicaltrials.gov shows that this trial is now recruiting participants. This medical study was first published on May 20th 2021 and has been modified most recently as of February 25th 2022. Thirty patients are required at one particular site to complete the study's objectives."
Answered by AI
What are the goals of this experimental research?
"This clinical trial's primary goal is to assess overall completion up to six months after radiation treatment. In order to do this, researchers will evaluate secondary objectives such as sexual function (as measured by the EORTC QLQ-CX24), genitourinary symptoms using Vaginal Assessment Scale and Vaginal Heal Assessment, which will be recorded graphically through boxplots, histograms and scatterplots for further analysis."
Answered by AI
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