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Cognitive Support Program for Patients With Brain Metastases

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ClinicalTrials.gov Identifier: NCT03537911
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
This study evaluates the feasibility and preliminary efficacy of a brief cognitive-behavioural program designed to improve cognitive functioning in people with brain metastases.

Condition or disease Intervention/treatment Phase
Metastases, CNS Behavioral: Cognitive Support Program Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Cognitive Support Program for Patients With Brain Metastases
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : November 28, 2018
Actual Study Completion Date : November 28, 2018

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Functional Assessment of Cancer Therapy - Cognitive [ Time Frame: 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.


Secondary Outcome Measures :
  1. Frontal Systems Behavior Scale [ Time Frame: 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.

  2. Hopkins Verbal Learning Test - Revised [ Time Frame: 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.

  3. Trail Making Test [ Time Frame: 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.

  4. Wechsler Digit Span Test [ Time Frame: 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.

  5. BADS Zoo Map Test [ Time Frame: 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.

  6. Controlled Oral Word Association Test [ Time Frame: 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.

  7. Functional Assessment of Cancer Therapy - Brain [ Time Frame: 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.

  8. Positive and Negative Affect Schedule [ Time Frame: 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.

  9. Hospital Anxiety and Depression Scale [ Time Frame: 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.

  10. Illness Intrusiveness Rating Scale [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537911


Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5S1W8
Sponsors and Collaborators
University Health Network, Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03537911     History of Changes
Other Study ID Numbers: 16-6056
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes