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Cognitive Support Program for Patients With Brain Metastases

15 april 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

18

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 90 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Functional Assessment of Cancer Therapy - Cognitive
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Frontal Systems Behavior Scale
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Health Network, Toronto

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2017

Primaire voltooiing (Werkelijk)

28 november 2018

Studie voltooiing (Werkelijk)

28 november 2018

Studieregistratiedata

Eerst ingediend

21 april 2018

Eerst ingediend dat voldeed aan de QC-criteria

15 mei 2018

Eerst geplaatst (Werkelijk)

25 mei 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 april 2019

Laatste update ingediend die voldeed aan QC-criteria

15 april 2019

Laatst geverifieerd

1 april 2019

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 16-6056

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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