Cognitive Support Program for Patients With Brain Metastases
15. dubna 2019 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
18
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Ontario
-
Toronto, Ontario, Kanada, M5S1W8
- Princess Margaret Cancer Centre
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 90 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Functional Assessment of Cancer Therapy - Cognitive
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Frontal Systems Behavior Scale
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. července 2017
Primární dokončení (Aktuální)
28. listopadu 2018
Dokončení studie (Aktuální)
28. listopadu 2018
Termíny zápisu do studia
První předloženo
21. dubna 2018
První předloženo, které splnilo kritéria kontroly kvality
15. května 2018
První zveřejněno (Aktuální)
25. května 2018
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
17. dubna 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
15. dubna 2019
Naposledy ověřeno
1. dubna 2019
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 16-6056
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .