Cognitive Support Program for Patients With Brain Metastases

Metastases, CNS Clinical Trial

Official title:

Cognitive Support Program for Patients With Brain Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03537911
• Other study ID #: 16-6056
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: November 28, 2018

Study information

• Verified date: April 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 28, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastases, CNS
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Assessment of Cancer Therapy - Cognitive	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)
Secondary	Frontal Systems Behavior Scale	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)
Secondary	Hopkins Verbal Learning Test - Revised	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)
Secondary	Trail Making Test	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)
Secondary	Wechsler Digit Span Test	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)
Secondary	BADS Zoo Map Test	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)
Secondary	Controlled Oral Word Association Test	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)
Secondary	Functional Assessment of Cancer Therapy - Brain	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)
Secondary	Positive and Negative Affect Schedule	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)
Secondary	Hospital Anxiety and Depression Scale	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)
Secondary	Illness Intrusiveness Rating Scale	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)