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

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ClinicalTrials.gov Identifier: NCT02603692
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : July 11, 2019
Sponsor:
Collaborator:
Alex's Lemonade Stand Foundation
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date August 3, 2015
First Posted Date November 13, 2015
Last Update Posted Date July 11, 2019
Study Start Date November 2014
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 12, 2015)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Health Related Quality of Life in Pediatric Central Nervous System (CNS) Tumors: A Feasibility Study Utilizing PROMIS
Official Title Health Related Quality of Life in Pediatric Central Nervous System (CNS) Tumors: A Feasibility Study Utilizing PROMIS
Brief 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.

Detailed 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).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition Brain Neoplasms
Intervention Other: PROMIS-QOL
PROMIS questionnaires completed every 3 months for up to 2 years.
Study Groups/Cohorts
  • Pediatric group (ages 8-17)
    PROMIS pediatric domains for emotional distress (anxiety and depression), physical function (fatigue, pain interference, mobility and upper extremity), and peer relations
    Intervention: Other: PROMIS-QOL
  • Adult group (ages 18-35)
    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.
    Intervention: Other: PROMIS-QOL
  • Parent/guardian proxy
    Parent/guardian will complete the parental proxy PROMIS instruments based on corresponding child age (ages 5 to 17 years)
    Intervention: Other: PROMIS-QOL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 12, 2015)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2018
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02603692
Other Study ID Numbers PROMIS-QOL
2014-5742 ( Other Identifier: Cincinnati Children's Hosp Med Ctr IRB#1 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators Alex's Lemonade Stand Foundation
Investigators
Principal Investigator: Mariko DeWire, MD Children's Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date July 2019