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Computerized Intervention for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors

28 aprile 2014 aggiornato da: St. Jude Children's Research Hospital
Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) show elevated rates of working memory impairment. Working memory (WM) is the ability to hold and manipulate information online; for example, when an individual mentally rehearses a phone number in order to dial it without writing it down. A computer-based working memory intervention has been successful in children diagnosed with ADHD and stroke survivors. Individuals participating in the intervention showed improvements on working memory measures as well as more complex problem solving skills. Neuroimaging (brain scans) conducted before and after training showed changes in brain activation suggestive of underlying changes in brain systems that support working memory. This study investigates the effectiveness of this computer-based working memory intervention for childhood cancer survivors.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Participants randomized to the intervention arm will complete the computerized working memory training program. This computer-based training program is completed in the home and requires approximately 30 minutes every weekday for five weeks. The program software guides the child through eight rotating exercises each day, with increasing difficulty based on the child's level of performance. Exercises train both visuospatial and verbal WM using child-friendly activities. A research team member will serve as a coach who monitors weekly progress online and offers support through weekly phone calls with the study participants and their caregivers. This individual will not complete post-intervention assessments to maintain study blind. A home computer with internet connection and speakers is required. A laptop computer and/or wireless internet access will be provided to families whose only obstacle to participation is lack of computer access or internet connectivity in the home setting. Families randomized to the WM intervention will complete a tutorial with study staff that provides instruction in using a computer, the internet and the WM training software.

The objective of this study is to investigate the benefits of this working memory intervention in a sample of childhood cancer survivors and look at brain-based changes that may occur as the result of working memory intervention. To achieve this goal, we plan to study childhood cancer survivors randomly assigned to the working memory intervention or a passive waitlist. Both groups will participate in cognitive testing pre-, post-, and six months post intervention. Intervention participants will also partake in neuroimaging exams before and after the intervention. Findings from this study have direct potential to support a nonpharmaceutical cognitive intervention for cancer survivors that is a safe and effective alternative to stimulant medications with great promise for improving quality of life.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

128

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Tennessee
      • Memphis, Tennessee, Stati Uniti, 38105
        • St. Jude Children's Research Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 8 anni a 16 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria for Screening Phase:

  • Received CNS-directed treatment (intrathecal chemotherapy or cranial irradiation) for a BT or ALL
  • Infratentorial tumor location (for the BT cohort)
  • Off treatment for at least one year with no evidence of recurrent or progressive disease
  • Age 8-16 years inclusive at the time of enrollment
  • English as the primary language
  • Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines

Exclusion Criteria for Screening Phase

  • Significant impairment in global intellectual functioning (estimated or full scale IQ < 70 based on standardized testing routinely conducted on primary treatment protocols)
  • History of CNS injury/disease predating or unrelated to cancer diagnosis
  • Documented ADHD predating cancer diagnosis
  • Treatment with psychostimulant or psychotropic medication within two weeks of study participation
  • Major sensory or motor impairment that would preclude valid cognitive testing secondary to inability to complete study procedures (e.g., blindness, paresis, poorly controlled seizures/photosensitive epilepsy, psychosis)

Inclusion Criteria for Intervention Phase

  • Signed screening consents and has undergone screening
  • Fully evaluable psychological testing results (including IQ > or = 70)
  • Age-scaled score on Digit Span, Letter-Number Sequencing or Spatial Span < 7 OR at least one standard deviation below IQ score
  • Training aide is available to participate in required sessions
  • Participant and training aide demonstrate computer proficiency
  • Participant has access to or will be provided a laptop or home computer with internet connection and speakers
  • Participant willing to participate in required aspects of computerized intervention
  • Participant is able to take part in fMRI without sedation

Exclusion Criteria for Intervention Phase

  • Major psychological condition that would preclude completion of protocol intervention (e.g., significant oppositionality, autism spectrum disorder, severe anxiety or depressive symptoms)
  • Orthodontic appliances that cause MRI distortion or signal loss outside the mouth and sinus area

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Intervention Group
Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) will complete the computerized working memory training program (intervention).
Comportamentale: Computerized working memory training program (intervention)
A computer-based training program will be completed in the home. This program requires approximately 30 minutes every weekday for five weeks. The program software guides the child through eight rotating exercises each day, with increasing difficulty based on the child's level of performance. Exercises train both visuospatial and verbal WM using child-friendly activities. A research team member will serve as a coach who monitors weekly progress online and offers support through weekly phone calls with the study participants and their caregivers). Intervention participants will also partake in neuroimaging exams before and after the intervention
Altro: Control Group
Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) will complete the computerized working memory training program (control).
Comportamentale: Computerized working memory training program (control)
Participants randomized to the control group will not complete any intervention during the intervention time period and will not partake in neuroimaging exams. They will complete an immediate and six month post follow-up cognitive assessment. Following completion of these assessments, they will be provided the opportunity to complete the computer-based training program off study.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
This study will measure working memory, attention and executive functions
Lasso di tempo: Baseline, 10 weeks, and 6 months
Participants in the working memory intervention will demonstrate significantly greater improvement from pre- to immediate post-intervention on performance- and rater-based measures of working memory relative to childhood cancer survivors placed on an intervention waitlist.
Baseline, 10 weeks, and 6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The study will measure the maintenance of improvements on measures of working memory, attention and executive functions
Lasso di tempo: 6 months.
The improvements will be evaluated at six months following participation in the computer-based intervention program.
6 months.
This study will examine the neural correlates of working memory before and immediately after intervention
Lasso di tempo: Baseline and 10 weeks.
This objective will use fMRI to examine the neural correlates of working memory before and immediately after intervention.
Baseline and 10 weeks.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

St. Jude Children's Research Hospital

Collaboratori

American Cancer Society, Inc.

Investigatori

  • Investigatore principale: Heather M Conklin, Ph.D, St. Jude Children's Research Hospital

Pubblicazioni e link utili

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Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2010

Completamento primario (Effettivo)

1 febbraio 2013

Completamento dello studio (Effettivo)

1 novembre 2013

Date di iscrizione allo studio

Primo inviato

7 ottobre 2010

Primo inviato che soddisfa i criteri di controllo qualità

7 ottobre 2010

Primo Inserito (Stima)

8 ottobre 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

29 aprile 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 aprile 2014

Ultimo verificato

1 aprile 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • COGTRN
  • 120421-RSGPB-11-009-01-CPPB (Altro numero di sovvenzione/finanziamento: American Cancer Society)

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 .

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