- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02603692
Health Related Quality of Life in Pediatric Central Nervous System (CNS) Tumors: A Feasibility Study Utilizing PROMIS (PROMIS-QOL)
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.
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
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
|
PROMIS questionnaires completed every 3 months for up to 2 years.
|
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.
|
PROMIS questionnaires completed every 3 months for up to 2 years.
|
Parent/guardian proxy
Parent/guardian will complete the parental proxy PROMIS instruments based on corresponding child age (ages 5 to 17 years)
|
PROMIS questionnaires completed every 3 months for up to 2 years.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
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.
Tidsramme: 24 months
|
24 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mariko DeWire, MD, Children's Hospital Medical Center, Cincinnati
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PROMIS-QOL
- 2014-5742 (Anden identifikator: Cincinnati Children's Hosp Med Ctr IRB#1)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Neoplasmer i hjernen
-
Guangzhou First People's HospitalAfsluttet
-
Assistance Publique Hopitaux De MarseilleUkendt
-
National Institute of Mental Health (NIMH)AfsluttetKÆLEDYR | Brain Imaging | Cannabinoid | CB1Forenede Stater
-
GE HealthcareAfsluttetBrain Imaging | Billedbehandling af hele kroppenForenede Stater
-
Mayo ClinicTilmelding efter invitationBrain Imaging | Billedbehandling af hele kroppenForenede Stater
-
Tang-Du HospitalIkke rekrutterer endnuPsykisk lidelse | Sociale medier | Brain Imaging
-
University Hospital TuebingenAfsluttetFunktionel dyspepsi | Mad | Brain ImagingTyskland
-
University of MichiganAfsluttetÆndringer i Brain Network ConnectivityForenede Stater
-
School of Health Sciences GenevaUniversity of Lausanne Hospitals; University of Geneva, SwitzerlandRekrutteringMR scanning | Opførsel | Funktionel magnetisk resonansbilleddannelse | Musik | Udvikling, barn | Brain Imaging | Executive funktioner | Hjerneplasticitet | Interventioner | Kunst | Strukturel hjerneforbindelseSchweiz
-
Rigshospitalet, DenmarkLundbeck Foundation; Filadelfia Epilepsy Hospital; Lennart Grams Mindefond...AfsluttetKirurgi | Refraktær epilepsi | Elektroencefalografi | Brain ImagingDanmark
Kliniske forsøg med PROMIS-QOL
-
Massachusetts General HospitalAfsluttetHåndkirurgiForenede Stater
-
Julia FinkelChildren's National Research Institute; Arizona State UniversityAfsluttetHæmatologiske sygdomme | Anæmi | Seglcellesygdom | Anæmi, seglcelle | Anæmi, hæmolytiskForenede Stater
-
GlaxoSmithKlineHealth Research Associates, Inc.AfsluttetNeoplasmerForenede Stater
-
Allina Health SystemAfsluttetPalliativ pleje | Rygrad | Medicinsk onkologi | Primære sundhedssektor | Integrativ medicin | Kardiologi | Fysisk og Rehabiliteringsmedicin | Ortopædi | LungemedicinForenede Stater
-
M.D. Anderson Cancer CenterTrukket tilbage
-
University of RochesterAmerican Orthopaedic Foot and Ankle SocietyAfsluttet
-
Chinese University of Hong KongRekrutteringSlag | Hjernesygdomme | Sundhedsholdning | Hjerneiskæmi | Demens | Alzheimers sygdom | Sund aldring | Slagtilfælde, iskæmisk | Slagtilfælde, Akut | Sundhedsviden, holdninger, praksis | Sundhedspersonalets holdning | Slagtilfælde syndromHong Kong
-
MediWound LtdAfsluttetLivskvalitet | Dannelse af arSlovakiet
-
Memorial Sloan Kettering Cancer CenterAfsluttet
-
University Hospital OstravaRekrutteringMultipel sclerose | Nedre urinvejssymptomerTjekkiet