Health Related Quality of Life in Pediatric Central Nervous System (CNS) Tumors: A Feasibility Study Utilizing PROMIS

Brain Neoplasms Clinical Trial

— PROMIS-QOL  

Official title:

Health Related Quality of Life in Pediatric Central Nervous System (CNS) Tumors: A Feasibility Study Utilizing PROMIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603692
• Other study ID #: PROMIS-QOL
• Secondary ID: 2014-5742
• Status: Completed
• Start date: November 2014
• Est. completion date: October 2018

Study information

• Verified date: July 2019
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 35 Years

Eligibility

Eligibility Criteria

• Patient must have diagnosis of a CNS tumor (newly diagnosed, relapsed, refractory, or progressed) and scheduled to receive a new therapy including surgery, chemotherapy and/or radiation therapy.

• Age: 5 -35 years of age.

• The planned therapy must include at least one disease evaluation with the first 90 days of therapy. The patient and family must intend to return to Cincinnati Children's Hospital at least once in the next 90 days.

• Each subject may only participate once in this study.

• The subject and/or his /her parent/guardian must be fluent in English. At the time of study enrollment, the medical care of the subject must be managed by an attending oncologist at Cincinnati Children's Hospital.

• The subject must have a minimum performance score of 50% (either Lansky or Karnofsky) as documented in their medical record by clinical provider (MD or nurse practitioner). Appendix I.

• A patient / family must be approached to participate in this study within 28 days of the administration of the first dose of the associated therapy or surgery.

Related Conditions & MeSH terms

• Brain Neoplasms

Intervention

Other:
• PROMIS-QOL
PROMIS questionnaires completed every 3 months for up to 2 years.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Alex's Lemonade Stand Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24 months

External Links

•   Cincinnati Children's Cancer and Blood Diseases Institute
•   Cincinnati Children's Hospital Oncology Division