CLINICAL TRIAL

Headspace Smartphone Application for Endometrial Neoplasms

Recruiting · 18+ · Female · Saint Louis, MO

This study is evaluating whether a smartphone application may help reduce anxiety for individuals with cancer.

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About the trial for Endometrial Neoplasms

Eligible Conditions
Uterine Cervical Neoplasms · Endometrial Neoplasms · Gynecologic Cancers · Quality of Life (QOL) · Opioids Use · Cervical Cancers · Endometrial Cancer

Treatment Groups

This trial involves 2 different treatments. Headspace Smartphone Application is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Headspace Smartphone Application
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for female patients aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Access to a smartphone
therapy The patient has been diagnosed with either endometrial cancer that is undergoing surgery or cervical cancer that is undergoing chemo-sensitizing radiation therapy. show original
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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: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
Screening: ~3 weeks
Treatment: Varies
Reporting: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Enrollment to 4 weeks post op for endometrial cancer. Enrollment to 6 weeks post treatment for cervical cancer..
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 Headspace Smartphone Application will improve 2 primary outcomes and 5 secondary outcomes in patients with Endometrial Neoplasms. Measurement will happen over the course of Enrollment to 6 weeks post treatment for cervical cancer..

Opiate Usage-Cervical Cancer
ENROLLMENT TO 6 WEEKS POST TREATMENT FOR CERVICAL CANCER.
The amount of opiates used during the acute treatment with chemoradiation for cervical cancer will be recorded.
ENROLLMENT TO 6 WEEKS POST TREATMENT FOR CERVICAL CANCER.
Opiate Usage-Endometrial cancer
ENROLLMENT TO 30 DAYS POST OP FOR ENDOMETRIAL CANCER.
The amount of opiates used during the acute (30 day) recovery after surgery for endometrial cancer or acute treatment with chemoradiation for cervical cancer will be recorded.
ENROLLMENT TO 30 DAYS POST OP FOR ENDOMETRIAL CANCER.
Complication Rates
ENROLLMENT TO 4 WEEKS POST OP FOR ENDOMETRIAL CANCER. ENROLLMENT TO 6 WEEKS POST TREATMENT FOR CERVICAL CANCER.
Surgical or treatment complications will be monitored in each group.
ENROLLMENT TO 4 WEEKS POST OP FOR ENDOMETRIAL CANCER. ENROLLMENT TO 6 WEEKS POST TREATMENT FOR CERVICAL CANCER.
Functional Assessment of Cancer Therapy-General
ENROLLMENT TO 4 WEEKS POST OP FOR ENDOMETRIAL CANCER. ENROLLMENT TO 6 WEEKS POST TREATMENT FOR CERVICAL CANCER.
Patients will be asked to complete a Functional Assessment of Cancer Therapy-General form at enrollment, on the day of surgery (endometrial cancer) or first brachytherapy (cervical cancer), and at their post-treatment visit.
ENROLLMENT TO 4 WEEKS POST OP FOR ENDOMETRIAL CANCER. ENROLLMENT TO 6 WEEKS POST TREATMENT FOR CERVICAL CANCER.
Five Facet Mindfulness Questionnaire
ENROLLMENT TO 4 WEEKS POST OP FOR ENDOMETRIAL CANCER. ENROLLMENT TO 6 WEEKS POST TREATMENT FOR CERVICAL CANCER.
Patients will be asked to complete a Five Facet Mindfulness Questionnaire form at enrollment, on the day of surgery (endometrial cancer) or first brachytherapy (cervical cancer), and at their post-treatment visit.
ENROLLMENT TO 4 WEEKS POST OP FOR ENDOMETRIAL CANCER. ENROLLMENT TO 6 WEEKS POST TREATMENT FOR CERVICAL CANCER.
Patient satisfaction
ENROLLMENT TO 4 WEEKS POST OP FOR ENDOMETRIAL CANCER. ENROLLMENT TO 6 WEEKS POST TREATMENT FOR CERVICAL CANCER.
Patients from each group will be asked to complete an anonymous study-specific survey evaluating their satisfaction with the program.
ENROLLMENT TO 4 WEEKS POST OP FOR ENDOMETRIAL CANCER. ENROLLMENT TO 6 WEEKS POST TREATMENT FOR CERVICAL CANCER.
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Who is running the study

Principal Investigator
S. G.
Prof. Shannon Grabosch, MD
St. Louis University

Patient Q & A Section

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

How many people get endometrial neoplasms a year in the United States?

Around 24,000 people in the Unites States annually have an endometrial neoplasm and around 6,000 people are diagnosed with an [endometrial cancer](https://www.withpower.com/clinical-trials/endometrial-cancer). However, the prevalence and mortality from these cancers remain unknown because of the rarity of endometrial neoplasms and cancers, especially endometrial cancer.

Anonymous Patient Answer

What causes endometrial neoplasms?

Because most endometrial neoplasms occur in post-menopausal women, it is not always possible to identify the hormone or estrogen receptor status of the lesion to definitively indicate what hormones may be of relevance. While no clear estrogenic cause of epithelial lesions has been established, both estrogen-dependent and estrogen-independent mechanisms may be active. Estrogen-dependent mechanisms arise from direct cellular growth stimulation caused by estrogen. Estrogen-independent mechanisms include, on one hand, the interaction of various cell constituents with estrogen, and on the other, the production of androgen-independent secreted factors.

Anonymous Patient Answer

What is endometrial neoplasms?

The most frequent endometrial neoplasms, in a worldwide sense, are a very old group of cancerous lesions. Nevertheless, endometrial sarcomas still constitute only 1% of these lesions. These neoplasms do not deserve much attention from a morphologic point of view, because the mainstay of diagnosis is not based on their appearance. On the other hand, benign proliferative lesions, which comprise about 90% of endometrial neoplasms, have a high potential of malignancy. Thus, more attention must be given to the diagnosis of these lesions.

Anonymous Patient Answer

Can endometrial neoplasms be cured?

Most primary endometrial cancers are treated with curettage only. Given that recurrence is extremely rare, patients should be assessed on an individual basis, and they should not be denied treatment if this is thought by the patient has cure potentially an important component of the decision making process for the patient and the clinician.

Anonymous Patient Answer

What are common treatments for endometrial neoplasms?

Treatment of endometrial neoplasm is dependent on type and grade of the tumor and location of the tumor within the uterus. For low-grade tumors and endometrioid types, surgery may be the best option for first-line treatment. Higher-grade tumors may progress or spread to other areas of the uterus, where more aggressive treatment may be indicated. Chemotherapy with either platinum-based or Taxane may also be of some benefit in the case of high-grade tumors with pelvic, distant, or liver spread. Radiation therapy may be an option for treatment if chemotherapy is not an option.

Anonymous Patient Answer

What are the signs of endometrial neoplasms?

Signs of endometrial neoplasms can be vague and nondescript. There may be an abnormal uterine bleeding suggestive of malignancy or a normal menstrual cycle. A biopsy or other surgical procedure should be taken to rule out malignancy.

Anonymous Patient Answer

What is the primary cause of endometrial neoplasms?

Endometrial cancers are often associated with a prior history of endometrial hyperplasia. In addition, some patients develop cancers outside the uterus. There is ongoing controversy whether some cases of cancer may develop from an epithelial precursor or whether they may develop elsewhere later in life and be interpreted as a endometrial cancer. The endometrial lining is constantly replaced by progesterone to produce a state of monthly amenorrhea. This is due to the action of inhibin produced by the corpus luteum and by the blastocyst. It is the loss of this monthly amenorrhea as a result of any factor that prevents progesterone production that prevents the endometrial cells from remaining immortal.

Anonymous Patient Answer

What is the survival rate for endometrial neoplasms?

Survival rates for early stage endometrial cancer that progressed within 2 years of surgery were less than 10%, while rates for advanced lesions that recurred after surgery more than 2 years had increased. The latter patients with recurrent endometrial cancer underwent surgery that may have contributed to the development of an metastatic lesion in the lung or other sites.

Anonymous Patient Answer

How serious can endometrial neoplasms be?

[Prognosis is important not only to women with these diseases but also to their husbands(http://www.brit-jesp.org/journal/article/view/10/10-2095/10-2095.) who may be encouraged by their wives to seek medical help after their wife is diagnosed with these disease. A complete menstrual cycle is important to assess whether a woman has endometriosis or cancer of the uterus. In women with endometriosis, the first indication that endometriosis is a problem is the appearance of dark, bloody spots in a woman's ovaries or in the fallopian tubes. In most women, these spotting are not abnormal.

Anonymous Patient Answer

How quickly does endometrial neoplasms spread?

Data from a recent study, our results showed that the rate of metastasis did not differ between the endometrioid and carcinoid subtypes. Considering that these tumors are usually endometriotic in origin and have an excellent survivability, in patients without clinical symptoms, surgical staging and treatment is usually an outpatient procedure.

Anonymous Patient Answer

What are the chances of developing endometrial neoplasms?

Although the lifetime risk of developing endometrial cancers is 1.6 percent, when endometrial cancer is present at the time of diagnosis, a diagnosis of endometrial cancer has a higher risk for development of a second endometrial cancer. To reduce the risk of developing another endometrial cancer, patients diagnosed with an endometrial cancer at an early stage of diagnosis are likely to need to be carefully followed up and to be treated with the most effective modality for endometrial cancer: surgery. At present, patients diagnosed with EC, endomyoma, and adenomyosis at an early stage are more likely to be successfully treated with a hysterectomy and more likely to go on to have children.

Anonymous Patient Answer

What are the common side effects of headspace smartphone application?

These side effects are not uncommon. However, the patient profile of those who experienced more severe side effects was distinct within the sample and may not necessarily represent the population of users.

Anonymous Patient Answer
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Get access to this novel treatment for Endometrial Neoplasms by sharing your contact details with the study coordinator.