CLINICAL TRIAL

Quality-of-Life Assessment for Genital Neoplasms, Female

Recruiting · 18+ · Female · Houston, TX

This study is evaluating whether a single radiation treatment may help improve symptoms of gynecologic cancers that have spread to other places in the body.

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About the trial for Genital Neoplasms, Female

Eligible Conditions
Metastatic Malignant Female Reproductive System Neoplasm · Genital Neoplasms, Female

Treatment Groups

This trial involves 2 different treatments. Quality-of-Life Assessment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Volume Modulated Arc Therapy
RADIATION
Quality-of-Life Assessment
OTHER
3-Dimensional Conformal Radiation Therapy
RADIATION
Questionnaire Administration
OTHER
Intensity-Modulated Radiation Therapy
RADIATION
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Volume Modulated Arc Therapy
RADIATION
Quality-of-Life Assessment
OTHER
3-Dimensional Conformal Radiation Therapy
RADIATION
Questionnaire Administration
OTHER
Intensity-Modulated Radiation Therapy
RADIATION

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3-Dimensional Conformal Radiation Therapy
2005
Completed Phase 3
~6740
Intensity-Modulated Radiation Therapy
2009
Completed Phase 3
~1210

Eligibility

This trial is for female patients aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Eastern Cooperative Oncology Group (ECOG) performance status of =< 3
Estimated life expectancy > 3 months at discretion of treating physician
Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Quality-of-Life Assessment will improve 1 primary outcome, 8 secondary outcomes, and 4 other outcomes in patients with Genital Neoplasms, Female. Measurement will happen over the course of Baseline up to 21 days post-radiation therapy.

>= 6 point increase in EuroQol-Visual Analogue Scale
BASELINE UP TO 21 DAYS POST-RADIATION THERAPY
Will summarize the number of patients with clinical meaningful health-related (HR)-quality of life (QOL) improvement using frequencies and proportions. The proportion of patients with clinically meaningful HR-QOL improvement will be compared between SFRT and MFRT using a chi-squared test.
Absolute change in activity
BASELINE UP TO 21 DAYS POST-RADIATION THERAPY
Each dimension is rated on a scale from 1 to 5 where 1 represents no problem present or patient can care for self and 5 represents extreme problems present or unable to care for self. Improvement within each dimension will be assessed by the absolute change of heath state. A decrease in the raw score by 1 or more points denotes improvement within the dimension.
Absolute change in self-care
BASELINE UP TO 21 DAYS POST-RADIATION THERAPY
Each dimension is rated on a scale from 1 to 5 where 1 represents no problem present or patient can care for self and 5 represents extreme problems present or unable to care for self. Improvement within each dimension will be assessed by the absolute change of heath state. A decrease in the raw score by 1 or more points denotes improvement within the dimension.
Absolute change in anxiety
BASELINE UP TO 21 DAYS POST-RADIATION THERAPY
Each dimension is rated on a scale from 1 to 5 where 1 represents no problem present or patient can care for self and 5 represents extreme problems present or unable to care for self. Improvement within each dimension will be assessed by the absolute change of heath state. A decrease in the raw score by 1 or more points denotes improvement within the dimension.
Absolute change in mobility
BASELINE UP TO 21 DAYS POST-RADIATION THERAPY
Each dimension is rated on a scale from 1 to 5 where 1 represents no problem present or patient can care for self and 5 represents extreme problems present or unable to care for self. Improvement within each dimension will be assessed by the absolute change of heath state. A decrease in the raw score by 1 or more points denotes improvement within the dimension.
Absolute change in pain
BASELINE UP TO 21 DAYS POST-RADIATION THERAPY
Each dimension is rated on a scale from 1 to 5 where 1 represents no problem present or patient can care for self and 5 represents extreme problems present or unable to care for self. Improvement within each dimension will be assessed by the absolute change of heath state. A decrease in the raw score by 1 or more points denotes improvement within the dimension.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is genital neoplasms, female?

Results from a recent clinical trial showed that about 40% of the genitourinary malignancies among Iranian female were sex chromosome-related and that more than 35% (22) was related to gonadotropic hormones.

Anonymous Patient Answer

What are common treatments for genital neoplasms, female?

The management of genital neoplasms is more complex than is generally thought. Although there are a number of potentially curative modalities, the majority of female patients will not derive a significant benefit from treatment. Appropriate multimodal approaches to the management of high-risk and invasive carcinomas are needed.

Anonymous Patient Answer

How many people get genital neoplasms, female a year in the United States?

An average of 8,958 people are diagnosed annually with female genital neoplasms. Around 1.5 million female and male patients are diagnosed annually. Female patients diagnosed with [cervical cancer](https://www.withpower.com/clinical-trials/cervical-cancer) is the most common. Female patients are the majority of those diagnosed, being about 86.7% of the total number of patients diagnosed. Female patients are the majority, being around 86.5% of all patients. Female patients make up around 92% of patients diagnosed with uterine cancer. Female patients were the second largest group of patients, with about 3% of all patients. Female patients make up less than 2% of patients with vulvar cancer. Female patients make up around 3% of all patients. Female patients make up 2.

Anonymous Patient Answer

What causes genital neoplasms, female?

This is a review of reported causes of genital neoplasms in women. This article also reviews and explains the various causes and signs/symptoms associated with a neoplasm of any type originating in the female genital tract. Most genitourinary tumors arise from the skin, the gastrointestinal tracts, the bladder or the uterus, the thyroid, or the breast. The uterine cervix is the site of the majority of cancers in women which have not been treated or are untreated by pelvic radiotherapy. The genital tract consists of the uterus, vagina, uterus, and its branches; the bladder, vulvae, anus, and rectum.

Anonymous Patient Answer

Can genital neoplasms, female be cured?

Very rare in the past 50 years, it is still not known if genital neoplasms can be cured or if this is merely a temporary condition, for which the patients had to be cured. Patients should be informed of the possibility of cure and the likelihood that it could occur.

Anonymous Patient Answer

What are the signs of genital neoplasms, female?

Vaginal changes are commonly the first symptom, while vulvar lesions are most often painless. Symptoms include abnormal vaginal lubrication, itching, bleeding and discharge. Other symptoms include urethral symptoms such as a burning sensation and pain and genital bleeding. Pain can also occur on urination. Symptoms do not always develop into genital symptoms of neoplasms such as carcinoma. We must be alert of symptoms of genital neoplasms in female patients.

Anonymous Patient Answer

What are the latest developments in quality-of-life assessment for therapeutic use?

More comprehensive tools for QoL measurement (including the assessment of patient-reported outcome measures) will be required to assess patients' perspectives and will help facilitate optimal therapeutic decision making.

Anonymous Patient Answer

What is the survival rate for genital neoplasms, female?

The 5-year survival rate for uterine corpus carcinoma is approximately 15%, and the 5-year survival rate for vaginal cancer is approximately 3%. The prognosis is better for younger women with the most aggressive tumours, such as endocervical cancer. Those with stage I endometrial cancer have a 5-year survival of 70%, and those with stage IIIC cancer have a 5-year survival of 40%, due to the presence of distant metastases. Survival depends also on the lymph node count.

Anonymous Patient Answer

What is the average age someone gets genital neoplasms, female?

Results from this study show a mean age at onset of 17, which confirms previous studies that report this disease as frequently occurring in women. Although, as discussed, there may be a variation in the mean age at onset according to patient population, genital neoplasms occur at similar rates in both sexes, with an average age of onset of 16 and 17, respectively. This age at onset confirms that it is not a disease of younger persons, and it is not a disease of older men. It is not understood why younger patients have an earlier age of onset of this disease than older patients (age >or=40). It is expected that the average age of onset would be 20 years in both sexes. [Power](http://www.

Anonymous Patient Answer

Is quality-of-life assessment safe for people?

QOL assessment was not associated with patient-reported harm. Based on these results, clinicians can more easily reassure some patients who need them. Nevertheless, to support their own clinical decision making clinicians should consult patients before making decisions on the timing of QOL assessment.

Anonymous Patient Answer

What does quality-of-life assessment usually treat?

Results from a recent clinical trial shows that QOL assessment facilitates a comprehensive assessment of all aspects of the client's cancer burden from the physical to the psychosocial and emotional domains. These assessments of the cancer burden are highly important to inform care planning, which is critical to all cancer survivors.

Anonymous Patient Answer

Is quality-of-life assessment typically used in combination with any other treatments?

Quality-of-life assessments were utilized less often in combination with other treatments. Given their proven utility in assessing patient outcomes, QOL assessments should be used for all patients and should be incorporated into clinical trials of any drug or treatment method.

Anonymous Patient Answer
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