Brain MetastasesNCT07355348
Feasibility of a Cognitive Stepped Care Program for Adults With Brain Metastases
A study testing Cognitive Stepped Care Program (CSCP) in people with Brain Metastases and Brain Metastasis, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Background: Cognitive symptoms are common and often severe in patients with brain metastases, significantly impacting their quality of life and ability to manage cancer care. Currently, there is no standard approach for routinely assessing and managing these symptoms in oncology clinics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Brain Metastasis
- What is being tested?
- Cognitive Stepped Care Program (CSCP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jan 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with a brain metastasis for any primary cancer
- Receiving follow-up care in the Brain Metastases Clinic
- Adult (≥ 18 years)
- Able to speak, read, and write in English
- Able to provide written informed consent
- Self-identified or identified by consenting patient as a primary caregiver for a person with brain metastases receiving follow-up in the Brain Metastases Clinic
Show all 13Show fewer
- Adult (≥ 18 years)
- Able to speak, read, and write in English
- Able to provide written informed consent
- Currently working as a clinician or administrative staff member in the Brain Metastases Clinic
- Adult (≥ 18 years)
- Able to speak, read, and write in English
- Able to provide written informed consent
Who cannot join
- History of significant developmental/learning disability or psychiatric disorder, acquired neurological disorder (e.g., traumatic brain injury)
- Poor performance status (ECOG ≥ 3)
- Life expectancy < 3 months
- Caregivers:
- N/A
- Staff:
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre, University Health Network
Toronto, Ontario, M5G 2M9
Samantha Mayo, RN, PhD, 1-437-218-0860, samantha.mayo@uhn.ca
About this study
Official title: Codesign of a Cognitive Stepped Care Program (CSCP) to Enhance Quality of Life in Adults With Brain Metastases: Evaluation of Feasibility, Acceptability and Preliminary Efficacy
Background: Cognitive symptoms are common and often severe in patients with brain metastases, significantly impacting their quality of life and ability to manage cancer care. Currently, there is no standard approach for routinely assessing and managing these symptoms in oncology clinics.
Objective: This study aims to evaluate the feasibility, acceptability, and preliminary efficacy of the Cognitive Stepped Care Program (CSCP) in a Brain Metastases Clinic.
Read more
Methods: This is a prospective, mixed-methods feasibility study involving patients with brain metastases, their caregivers, and clinic staff. Patients will undergo routine cognitive symptom screening using a standardized tool. Based on symptom severity, they will receive tiered interventions ranging from no support, to education materials, to computerized cognitive testing with individualized debrief, with group strategy training and/or neuropsychological consultation, as needed. Patients will complete questionnaires before and after the intervention regarding their symptoms and quality of life. Patients, caregivers and staff will provide their feedback about the intervention through questionnaires and interviews.
Outcomes: Primary outcomes include feasibility and acceptability of the CSCP. Secondary outcomes include preliminary changes in cognitive symptoms, self-efficacy, and quality of life.
Significance: This study will inform the potential integration of a structured cognitive support program into standard care for patients with brain metastases and may provide a model for similar interventions in other oncology settings.
- Conditions
- Brain Metastases, Brain Metastasis
- Being tested
- Cognitive Stepped Care Program (CSCP)
- Keywords
- cancer-related cognitive impairment, brain metastases, brain metastasis, stepped care, symptom management
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Stepped Care Program (CSCP)Behavioural
The Cognitive Stepped Care Program comprises two steps:
- Cognitive Symptom Screening: Patients will complete a 10-item cognitive screening tool. Each item is rated from 0-10, with thresholds for mild, moderate and severe symptoms.
- Cognitive Symptom Management. Patients will receive a cognitive symptom management intervention tailored to their symptom severity. Symptom management interventions will be based on the highest response score across the 10-item screening tool, ranging from no support (no symptoms), to educational materials (mild symptoms), to computerized cognitive testing with an individualized debrief (moderate-severe symptoms), with group strategy training and/or neuropsychological consultation provided as needed.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Stepped Care Program | Experimental | Not described Receives: Behavioral: Cognitive Stepped Care Program (CSCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Completion Rate
Proportion of patients who are able to complete the CSCP (i.e. complete the cognitive symptom management intervention as allocated to them based on cognitive screening score)
Measured: Through study completion, an average of 1 month
Intervention Satisfaction
Rating on a 5-point Likert scale (0-poor to 4-excellent), with optional open-text item for additional comments
Measured: Through study completion, an average of 1 month
Descriptions of Feasibility
Post-intervention qualitative interviews with participants (patients/caregivers one week after their last interaction of the CSCP, or staff at the completion of the study period) will also explore their perceptions of the feasibility and acceptability of the CSCP, including suggestions for improvement of the intervention.
Measured: Through study completion, an average of 1 month
Recruitment Rate
Proportion of eligible participants who are enrolled in the study
Measured: Baseline
Retention Rate
Proportion of patients who complete the study (i.e. pre-post data collection)
Measured: Through study completion, an average of 1 month
Secondary outcomes (10)
Intervention Reach
We will examine the representativeness of the patients were enrolled in the CSCP. For all consented patient participants, we will collect demographic and clinical information through a study-specific questionnaire and a review of health records. This will be compared to historical patient demographics from the study setting.
Measured: Baseline
Intervention Efficacy (Preliminary) - Change in Cognitive Symptom Severity
Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog3)
Measured: Baseline and up to 4 months
Intervention Effectiveness (Preliminary) - Change in Perceived Self-Efficacy
Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS 4-item General Self-Efficacy)
Measured: Baseline and up to 4 months
Intervention Effectiveness (Preliminary) - Change in Cancer-related Quality of Life
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30)
Measured: Baseline and up to 4 months
Intervention Efficacy (Preliminary) - Change in Cancer-related Quality of Life - Brain-specific
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire BN-20 (EORTC QLQ-BN20) for brain-specific symptoms
Measured: Baseline and up to 4 months
Intervention Efficacy (Preliminary) - Perceptions
Post-intervention qualitative interviews will include questions about what participants found most valuable (patients, caregivers, staff), the impact on their overall well-being (patients), and if there were, any negative experience associated with the CSCP (patients, caregivers, staff).
Measured: Up to 4 months
Intervention Adoption
Post-intervention qualitative interviews will explore perceptions from patients, caregivers, and staff about the potential motivations for the adoption of the CSCP within the Brain Metastasis clinic and/or the organization more broadly. Questions will also gauge facilitators and barriers to this adoption.
Measured: Up to 1 year
Intervention Implementation - Factors Influencing CSCP Fidelity
From CSCP case logs, we will collect the time spent per patient on the CSCP, any adverse events, and any challenges to implementation fidelity (e.g., scheduling, technical issues).
Measured: Up to 1 year
Intervention Implementation - Perceptions
Interviews with patients, caregivers, and staff will gather feedback on challenges to implementation and what strategies, tools, or infrastructure would need to be developed to better ensure that the intervention is delivered as intended.
Measured: Up to 1 year
Intervention Maintenance
Staff interviews will explore anticipated facilitators and barriers to long-term implementation within standard care, including its impact on other services.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start9 Jan 2026
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Mayo, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355348
- Sponsor's protocol ID
- 25-5444.0
- Status last verified
- Jan 2026
- First submitted
- 31 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not currently included in the approved protocol
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Codesign of a Cognitive Stepped Care Program (CSCP) to Enhance Quality of Life in Adults With Brain Metastases: Evaluation of Feasibility, Acceptability and Preliminary Efficacy
- ClinicalTrials.gov ID
- NCT07355348
- Acronym / sponsor ID
- 25-5444.0
- Conditions
- Brain Metastases, Brain Metastasis
- Keywords
- cancer-related cognitive impairment, brain metastases, brain metastasis, stepped care, symptom management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Jan 2026 (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.
Background: Cognitive symptoms are common and often severe in patients with brain metastases, significantly impacting their quality of life and ability to manage cancer care. Currently, there is no standard approach for routinely assessing and managing these symptoms in oncology clinics.
Objective: This study aims to evaluate the feasibility, acceptability, and preliminary efficacy of the Cognitive Stepped Care Program (CSCP) in a Brain Metastases Clinic.
Methods: This is a prospective, mixed-methods feasibility study involving patients with brain metastases, their caregivers, and clinic staff. Patients will undergo routine cognitive symptom screening using a standardized tool. Based on symptom severity, they will receive tiered interventions ranging from no support, to education materials, to computerized cognitive testing with individualized debrief, with group strategy training and/or neuropsychological consultation, as needed. Patients will complete questionnaires before and after the intervention regarding their symptoms and quality of life. Patients, caregivers and staff will provide their feedback about the intervention through questionnaires and interviews.
Outcomes: Primary outcomes include feasibility and acceptability of the CSCP. Secondary outcomes include preliminary changes in cognitive symptoms, self-efficacy, and quality of life.
Significance: This study will inform the potential integration of a structured cognitive support program into standard care for patients with brain metastases and may provide a model for similar interventions in other oncology settings.
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 Stepped Care Program | Experimental | Behavioral: Cognitive Stepped Care Program (CSCP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosed with a brain metastasis for any primary cancer
- Receiving follow-up care in the Brain Metastases Clinic
- Adult (≥ 18 years)
- Able to speak, read, and write in English
- Able to provide written informed consent
Key exclusion criteria (7 listed)
- History of significant developmental/learning disability or psychiatric disorder, acquired neurological disorder (e.g., traumatic brain injury)
- Poor performance status (ECOG ≥ 3)
- Life expectancy < 3 months
- N/A
- N/A
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 Stepped Care Program (CSCP)The Cognitive Stepped Care Program comprises two steps: 1. Cognitive Symptom Screening: Patients will complete a 10-item cognitive screening tool. Each item is rated from 0-10, with thresholds for mild, moderate and severe symptoms. 2. Cognitive Symptom Management. Patients will receive a cognitive symptom management intervention tailored to their symptom severity. Symptom management interventions will be based on the highest response score across the 10-item screening tool, ranging from no support (no symptoms), to educational materials (mild symptoms), to computerized cognitive testing with an individualized debrief (moderate-severe symptoms), with group strategy training and/or neuropsychological consultation provided as needed. | Behavioural | Cognitive Stepped Care Program |
Primary outcome
Intervention Completion Rate
Time frame: Through study completion, an average of 1 month
Proportion of patients who are able to complete the CSCP (i.e. complete the cognitive symptom management intervention as allocated to them based on cognitive screening score)
Intervention Satisfaction
Time frame: Through study completion, an average of 1 month
Rating on a 5-point Likert scale (0-poor to 4-excellent), with optional open-text item for additional comments
Descriptions of Feasibility
Time frame: Through study completion, an average of 1 month
Post-intervention qualitative interviews with participants (patients/caregivers one week after their last interaction of the CSCP, or staff at the completion of the study period) will also explore their perceptions of the feasibility and acceptability of the CSCP, including suggestions for improvement of the intervention.
Recruitment Rate
Time frame: Baseline
Proportion of eligible participants who are enrolled in the study
Retention Rate
Time frame: Through study completion, an average of 1 month
Proportion of patients who complete the study (i.e. pre-post data collection)
10 secondary outcomes
Intervention Reach
Time frame: Baseline
Intervention Efficacy (Preliminary) - Change in Cognitive Symptom Severity
Time frame: Baseline and up to 4 months
Intervention Effectiveness (Preliminary) - Change in Perceived Self-Efficacy
Time frame: Baseline and up to 4 months
Intervention Effectiveness (Preliminary) - Change in Cancer-related Quality of Life
Time frame: Baseline and up to 4 months
Intervention Efficacy (Preliminary) - Change in Cancer-related Quality of Life - Brain-specific
Time frame: Baseline and up to 4 months
Intervention Efficacy (Preliminary) - Perceptions
Time frame: Up to 4 months
Intervention Adoption
Time frame: Up to 1 year
Intervention Implementation - Factors Influencing CSCP Fidelity
Time frame: Up to 1 year
Intervention Implementation - Perceptions
Time frame: Up to 1 year
Intervention Maintenance
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No. Not currently included in the approved protocol
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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.
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 Stepped Care Program (CSCP) in people with Brain Metastases and Brain Metastasis, 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 13 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha Mayo, RN, PhD (1-437-218-0860, samantha.mayo@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Completion Rate (time frame: Through study completion, an average of 1 month). The study lists 5 primary outcomes in all. 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 21 Jan 2026.