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Cognitive Support Program for Patients With Brain Metastases

15 aprile 2019 aggiornato da: University Health Network, Toronto
This study evaluates the feasibility and preliminary efficacy of a brief cognitive-behavioural program designed to improve cognitive functioning in people with brain metastases.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Cognitive impairments (such as problems with attention, executive functions, memory and language abilities) are common in people with brain metastases as a result of disease and/or treatment effects. These impairments can significantly limit functional independence, participation in valued roles and activities, and overall quality of life.

Building on research in other cognitively-impaired populations, we designed a brief, structured, patient-centered Cognitive Support Program (CSP) for brain metastases patients, who have the option of participating with a caregiver. Program contents include supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration). This prospective, single-arm study will enroll 24 brain metastases patients to evaluate the feasibility and preliminary efficacy of the CSP. A battery of outcome measures is administered (1) prior to intervention, (2) after completing the CSP, and (3) after an additional 3 months to evaluate longer-term outcomes. Feasibility assessment will include program retention and adherence. Reliable change analyses will examine treatment effects, with regression analyses to explore moderating effects of select patient, disease and treatment factors (e.g., severity of baseline cognitive impairment, number of brain lesions, cranial radiation dose and distribution). Results of this trial will inform further development and implementation of evidence-based supportive care for cognitively-impaired brain metastases patients.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

18

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S1W8
        • Princess Margaret Cancer Centre

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 18 anni a 90 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • age 18 or older
  • able to provide informed consent to all procedures
  • diagnosis of one or more brain metastases, with primary cancer outside the CNS
  • indication of cognitive deficits from self-report and/or cognitive testing
  • interest in participating in a cognitive rehabilitation program
  • able to complete study activities

Exclusion Criteria:

  • concurrent non-cancer-related neurological or major psychiatric disorder or other medical condition suspected to influence cognition

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: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Cognitive Support Program
Three individual sessions of supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration), with practice applying program content between sessions.
Comportamentale: Cognitive Support Program
Three individual sessions of supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration), with practice applying program content between sessions.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Functional Assessment of Cancer Therapy - Cognitive
Lasso di tempo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Multi-domain cognitive symptom questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Frontal Systems Behavior Scale
Lasso di tempo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Executive cognitive symptom questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Hopkins Verbal Learning Test - Revised
Lasso di tempo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Neurocognitive test of memory completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Trail Making Test
Lasso di tempo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Neurocognitive test of processing speed and executive function completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Wechsler Digit Span Test
Lasso di tempo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Neurocognitive test of working memory completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
BADS Zoo Map Test
Lasso di tempo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Neurocognitive test of executive function completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Controlled Oral Word Association Test
Lasso di tempo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Neurocognitive test of verbal fluency completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Functional Assessment of Cancer Therapy - Brain
Lasso di tempo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Health-related quality of life questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Positive and Negative Affect Schedule
Lasso di tempo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Quality of life (well-being) questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Hospital Anxiety and Depression Scale
Lasso di tempo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Quality of life (psychological distress) questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Illness Intrusiveness Rating Scale
Lasso di tempo: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Quality of life (activity participation) questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)

Collaboratori e investigatori

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

Sponsor

University Health Network, Toronto

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 (Effettivo)

1 luglio 2017

Completamento primario (Effettivo)

28 novembre 2018

Completamento dello studio (Effettivo)

28 novembre 2018

Date di iscrizione allo studio

Primo inviato

21 aprile 2018

Primo inviato che soddisfa i criteri di controllo qualità

15 maggio 2018

Primo Inserito (Effettivo)

25 maggio 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 aprile 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 aprile 2019

Ultimo verificato

1 aprile 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 16-6056

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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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