- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01115777
Prospective Assessment of Quality of Life (QOL) in Pediatric Patients Treated With Radiation Therapy for Brain Tumors and Non-central Nervous System (Non-CNS) Malignancies
Prospective Assessment of Quality of Life (QOL) in Pediatric Patients Treated With Radiation Therapy for Brain Tumors and Non-CNS Malignancies
In recent years, remarkable advances in medical oncology, surgery, and radiology have allowed for increasing cure rates for childhood malignancies. This success has led to an emerging understanding of the kinds of effects that treatments can have on the pediatric population and how such effects can influence pediatric cancer survivor's functioning and quality of life. It has become tremendously important to assess the long-term complications due to therapy in this growing sector of survivors and to tailor our treatments so as to minimize these late effects.
The Investigators at MGH are committed to improving the delivery of radiotherapy to our patients and improving the outcome for these patients. MGH has an on-site cyclotron for proton radiotherapy in order to provide the most advanced care for patients in need. Proton therapy possesses a clinical advantage over standard photon therapy in that its optimal dose distribution delivers the bulk of radiation to the tumor site. This method spares the greatest volume of normal tissue, resulting in decreased short-term and long-term morbidity.
Through open pediatric protocols for patients treated with proton radiotherapy, the investigators aim to define and report the acute and late effects associated with treatment.
The investigators also treat a number of patients off-protocol with both proton and photon radiotherapy, and are interested in reporting these patients' QOL outcomes in conjunction with other clinical data that may be pertinent to the site of tumor treatment. This research is significant in that it will allow us to delineate the positive and negative effects of radiation treatment on patients' QOL, highlighting points of success and exposing areas that are in need of improvement. Such knowledge will be used to improve the experience of pediatric cancer survivors in the future.
The aims of this study are: 1) to prospectively collect and report the QOL outcomes in patients treated with radiotherapy and 2) to correlate the QOL data with pertinent clinical information.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Any patient being treated with radiation therapy with curative intent
- Patients between the ages of 2 and 25
- Patients who speak either English or Spanish
- Patients who agree to fill out the questionnaire
Exclusion Criteria:
- Patients younger than 2 years of age or over 25
- Patients receiving treatment with palliative intent
- Patients who do not wish to participate
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Pediatric patients treated with radiotherapy
|
Quality of Life surveys (no treatment)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessment of Quality of Life
Tidsramme: 10 years
|
Longitudinal description of quality of life outcomes in patients treated with radiation therapy
|
10 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Correlation of QOL data with clinical information
Tidsramme: 10 years
|
10 years
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Torunn Yock, MD, Massachusetts General Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Antatt)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2005P001629
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