An observational study in Brain Neoplasms, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 5 Years to 35 Years. Per ClinicalTrials.gov, last updated 2019-07-11.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
In this research study the investigators want to learn more about the quality of life before, during and after cancer treatment in patients with central nervous system brain tumors. Often CNS tumors and cancer treatment can cause many physical and emotional problems and side effects. Some of these problems and treatment side effects can cause a change in a patient's qualify of life and overall well-being. Quality of life questionnaires are used to measure well-being and ability to carry out daily activities by asking patients to answer several questions about their physical, emotional, and social well-being.
In this research study we want to find out if patient's answers to these questions change over the course of your treatment. We also want to see if doctors and nurses can use these answers to the questions to help patients feel better and increase their activity during cancer treatment.
Pediatric CNS tumors are the second most common form of pediatric cancer and the leading cause of death related to pediatric malignancies. Over decades of work and through the efforts of collaborative groups, cure rates have increased significantly. However, various types of CNS malignancy outcomes have remained stagnant. Moreover, side effects from treatments of even the most curable CNS tumors may have dramatic short and long-term sequela ranging from cognitive, endocrine malfunction, functional mobility, neurological, and ophthalmologic compromises. As science and protocol directed therapies continue to find cures for these patients, work also must continue in efforts to explore patient reported outcomes (PROs) and health related quality of life (HRQOL) throughout the trajectory of a patient's disease process. Increased efforts in patient reported outcomes will lead to improvements in symptom management, functional status, and overall quality of life (QOL).
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 380 observational studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients ages 5-35 with a diagnosis of a Central Nervous System (CNS) tumor (newly diagnosed, relapsed, refractory, or progressed) and scheduled to receive a new therapy including surgery, chemotherapy and/or radiation therapy.
Eligibility Criteria
PROMIS pediatric domains for emotional distress (anxiety and depression), physical function (fatigue, pain interference, mobility and upper extremity), and peer relations
Other: PROMIS-QOL
PROMIS adult domains. To reduce respondent burden, the multi-form design will be used which includes the short form of physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference and pain intensity.
Other: PROMIS-QOL
Parent/guardian will complete the parental proxy PROMIS instruments based on corresponding child age (ages 5 to 17 years)
Other: PROMIS-QOL
PROMIS questionnaires completed every 3 months for up to 2 years.
Number of participants to complete at least 75% of the Patient Reported Outcomes Measurement Information System (PROMIS) tool in pediatric and adult patients with brain tumors.
Time frame: 24 months
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati