NCT00876499

Brief Summary

This goal of this research study is to learn more about fatigue, sleep quality, and other symptoms in patients with primary brain tumors who are being treated with radiation therapy. Objectives: PRIMARY OBJECTIVE: 1\. The primary objective of this study is to provide preliminary data describing the severity and change over time in fatigue using the Brief Fatigue Inventory (BFI) during radiation therapy for patients with primary gliomas. SECONDARY OBJECTIVES:

  1. 1.To evaluate longitudinal changes in the severity of symptoms and the mean symptom burden as measured by the M.D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) and mood using the Profile of Mood States (POMS) during radiation therapy.
  2. 2.To assess alterations in circadian rhythms using actigraphy during radiation therapy and the association with sleep quality tools - Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale(ESS), and the severity of BFI and MDASI-BT scores over time.
  3. 3.To explore the association between the levels of salivary hormones (melatonin and cortisol) and the occurrence of fatigue and symptom burden.

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 Jan 2009

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

January 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2009

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

4.9 years

First QC Date

April 3, 2009

Last Update Submit

January 7, 2015

Conditions

Brain Cancer

Keywords

Primary Brain TumorPBTBrain CancerPrimary gliomaAstrocytomaOligodendrogliomaOligo-astrocytomaEpendymomaAnaplastic astrocytomaAnaplastic oligodendrogliomaAnaplastic oligo-astrocytomaAnaplastic ependymomaFatigueCytokinesQuestionnairesActigraphySleep DisturbanceRadiation Therapy

Outcome Measures

Primary Outcomes (1)

  • Patient Responses to Brief Fatigue Inventory (BFI)

    BFI at baseline, at each weekly assessment, and again at the post-therapy assessment (3-4 weeks following chemotherapy).

Study Arms (1)

Questionnaire

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

A total of 8 questionnaires regarding fatigue taking approximately 30 minutes each, given before radiation therapy, weekly during, and after completion.

Also known as: Survey
Questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals over 18 years of age with a primary brain tumor scheduled for radiation therapy.

You may qualify if:

  • A new diagnosis of a primary glioma, astrocytoma, oligodendroglioma, oligo-astrocytoma, ependymoma, tanycytic ependymoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligo-astrocytoma, anaplastic ependymoma
  • Radiation therapy as part of the plan of care
  • Age \>/= 18 years of age. Children are excluded from this study because of differences in tumor location and biology with differing symptom clusters. A separate study will be conducted in the future with children.
  • Ability to speak, write, and read English
  • On corticosteroids at the initiation of radiation therapy.

You may not qualify if:

  • Tumors involving the suprasellar region, including the pituitary and hypothalamus
  • Cognitive deficits which limit ability to self-report symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Brain NeoplasmsAstrocytomaOligodendrogliomaEpendymomaFatigueParasomnias

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Wake DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Mark R. Gilbert

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 6, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 9, 2015

Record last verified: 2015-01

Locations

US(1)