Cognitive Support Program for Patients With Brain Metastases
15. april 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
18
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5S1W8
- Princess Margaret Cancer Centre
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional Assessment of Cancer Therapy - Cognitive
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Frontal Systems Behavior Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2017
Primær færdiggørelse (Faktiske)
28. november 2018
Studieafslutning (Faktiske)
28. november 2018
Datoer for studieregistrering
Først indsendt
21. april 2018
Først indsendt, der opfyldte QC-kriterier
15. maj 2018
Først opslået (Faktiske)
25. maj 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. april 2019
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 16-6056
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