NCT02603692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

2.8 years

First QC Date

August 3, 2015

Last Update Submit

July 9, 2019

Conditions

Brain Neoplasms

Keywords

Newly diagnosed brain tumorProgressive brain tumorPROMISQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

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.

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)

Other: PROMIS-QOL

Interventions

PROMIS-QOLOTHER

PROMIS questionnaires completed every 3 months for up to 2 years.

Adult group (ages 18-35)Parent/guardian proxyPediatric group (ages 8-17)

Eligibility Criteria

Age5 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Links

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mariko DeWire, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2015

First Posted

November 13, 2015

Study Start

November 1, 2014

Primary Completion

August 1, 2017

Study Completion

October 1, 2018

Last Updated

July 11, 2019

Record last verified: 2019-07

Locations

US(1)