Metastases, CNSNCT03537911
Cognitive Support Program for Patients With Brain Metastases
A study testing Cognitive Support Program in people with Metastases, CNS, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Metastases, CNS
- What is being tested?
- Cognitive Support Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2017to 28 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- concurrent non-cancer-related neurological or major psychiatric disorder or other medical condition suspected to influence cognition
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the feasibility and preliminary efficacy of a brief cognitive-behavioural program designed to improve cognitive functioning in people with brain metastases.
Read the 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.
- Conditions
- Metastases, CNS
- Being tested
- Cognitive Support Program
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Support ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Support Program | Experimental | 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. Receives: Behavioral: Cognitive Support Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Secondary outcomes (10)
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.
Measured: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
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.
Measured: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
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.
Measured: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
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.
Measured: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
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.
Measured: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
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.
Measured: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
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.
Measured: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
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.
Measured: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
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.
Measured: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
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.
Measured: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start1 Jul 2017
- Primary completion28 Nov 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastases, CNSStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537911
- Sponsor's protocol ID
- 16-6056
- Status last verified
- Apr 2019
- First submitted
- 21 Apr 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Support Program for Patients With Brain Metastases
- ClinicalTrials.gov ID
- NCT03537911
- Acronym / sponsor ID
- 16-6056
- Conditions
- Metastases, CNS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the feasibility and preliminary efficacy of a brief cognitive-behavioural program designed to improve cognitive functioning in people with brain metastases.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Support Program | Experimental | Behavioral: Cognitive Support ProgramThree 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- concurrent non-cancer-related neurological or major psychiatric disorder or other medical condition suspected to influence cognition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Support ProgramThree 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. | Behavioural | Cognitive Support Program |
Primary outcome
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.
10 secondary outcomes
Frontal Systems Behavior Scale
Time frame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Hopkins Verbal Learning Test - Revised
Time frame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Trail Making Test
Time frame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Wechsler Digit Span Test
Time frame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
BADS Zoo Map Test
Time frame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Controlled Oral Word Association Test
Time frame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Functional Assessment of Cancer Therapy - Brain
Time frame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Positive and Negative Affect Schedule
Time frame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Hospital Anxiety and Depression Scale
Time frame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Illness Intrusiveness Rating Scale
Time frame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Metastases, CNS
RecruitingPhase 1
A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS)
Recurrent Medulloblastoma, Refractory Medulloblastoma
RecruitingPhase 2
Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)
Brain Metastases, Cancer (With CNS Involvement)
RecruitingPhase 1
A Phase 1/1b Study of IAM1363 in HER2 Cancers
HER2 Mutation-Related Tumors, HER2
RecruitingObservational study
A Phase II Observational Clinical Study on the Relationship Between Cerebrospinal Fluid Drug Concentration and Efficacy of Trastuzumab Deruxtecan in Central Nervous System Metastatic Breast Cancer
Central Nervous System (CNS) Metastases, Breast Cancer
RecruitingPhase 1/2
Selinexor With ICE Chemotherapy in Secondary Central Nervous System Involving B-cell Non-Hodgkin Lymphoma
B-cell Lymphoma Recurrent, B-cell Lymphoma Refractory
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Support Program in people with Metastases, CNS, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy - Cognitive (time frame: Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019; AzTrials last refreshed its copy on 2 Nov 2026.