Quality of Life of Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Longitudinal Assessment of Neurocognitive Function and Quality of Life of Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) Undergoing Treatment
Primary Objectives:
- To compare the neuropsychiatric (NP) and neurocognitive (NC) symptoms and assess the quality of life (QOL) in older patients (age > 18) with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS) receiving different therapies, chemotherapy (Clofarabine + ara-C) or targeted therapies (PKC412 + low-dose ara-C, or R115777 + low-dose ara-C, or decitabine, or STI + low-dose ara-C).
- To determine whether there is a correlation between the number of packed red blood cell (PRBC) transfusions and cognitive scores and/or QOL.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
You will participate in a series of neurocognitive tests. For these tests, you will be asked to complete certain tasks that require the use of your hands, eyes, and ears. The neurocognitive testing will take about 30 minutes.
You will answer some questionnaires about disease symptoms and your quality of life. It will take about 30 minutes to complete the questionnaires.
You will participate in these neurocognitive tests and fill out the questionnaires before you begin cancer therapy. Your interval testing will coincide with your clinic visit evaluations, which will be approximately at 1 month, 3 months, and 6 months. If you do not receive therapy, you will be asked to complete the neurocognitive tests at baseline and then again on your follow up clinic visit evaluations, which will be approximately at 3 months and at 6 months. You may be asked to continue your participation in these neurocognitive tests and fill out questionnaires approximately every 3 months thereafter.
This is an investigational study. About 306 patients will take part in this study. All will be enrolled at UTMDACC.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- U.T.M.D. Anderson Cancer Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Patients with newly diagnosed AML or MDS. Patients who fail an MDS/AML therapy and receive other therapies may be asked to continue participation in this neurocognitive study.
- Patients who are 18 years of age or older.
- Patients who are seen in the MDACC adult Leukemia clinic. Patients who do not enroll onto therapy protocols are also eligible.
- Patients must sign the informed consent.
Exclusion Criteria:
1) Not applicable
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Questionnaire
AML and MDS Patients
|
Questionnaires taking about 30 minutes to complete.
Altri nomi:
Neurocognitive testing lasting 30 minutes.
Patients will be asked to complete certain tasks that require the use of their hands, eyes, and ears.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Effect of cancer therapy on AML or MDS patients (longitudinal assessment neuropsychiatric (NP), neurocognitive (NC) symptoms, quality of life (QOL))
Lasso di tempo: Interval testing will be approximately at 1 month, 3 months, and 6 months.
|
Interval testing will be approximately at 1 month, 3 months, and 6 months.
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Effects of therapy on the ability to think, quality of life, the ability to perform everyday tasks, and how often side effects occur.
Lasso di tempo: 6 Years
|
6 Years
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Christina A. Meyers, PhD, M.D. Anderson Cancer Center
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2004-0060
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .