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NCT Number: NCT07355348

Feasibility of a Cognitive Stepped Care Program for Adults With Brain Metastases

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.

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Key information

Conditions

Brain Metastases Brain Diseases Brain Metastasis Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre, University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location status: Recruiting

Location contact

Samantha Mayo, RN, PhD

CONTACT

[email protected]

1-437-218-0860

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients:

Inclusion criteria

  • 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

Exclusion criteria

  • 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:

Inclusion criteria

  • 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
  • Adult (≥ 18 years)
  • Able to speak, read, and write in English
  • Able to provide written informed consent

Exclusion criteria

  • N/A

Staff:

Inclusion criteria

  • 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

Exclusion criteria

  • N/A

Treatment and study plan

Cognitive Stepped Care Program (CSCP)

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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

  3. 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.

  4. Recruitment Rate

    Time frame: Baseline

    Proportion of eligible participants who are enrolled in the study

  5. 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)

Secondary outcomes

  1. Intervention Reach

    Time frame: Baseline

    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.

  2. Intervention Efficacy (Preliminary) - Change in Cognitive Symptom Severity

    Time frame: Baseline and up to 4 months

    Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog3)

  3. Intervention Effectiveness (Preliminary) - Change in Perceived Self-Efficacy

    Time frame: Baseline and up to 4 months

    Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS 4-item General Self-Efficacy)

  4. Intervention Effectiveness (Preliminary) - Change in Cancer-related Quality of Life

    Time frame: Baseline and up to 4 months

    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30)

  5. Intervention Efficacy (Preliminary) - Change in Cancer-related Quality of Life - Brain-specific

    Time frame: Baseline and up to 4 months

    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire BN-20 (EORTC QLQ-BN20) for brain-specific symptoms

  6. Intervention Efficacy (Preliminary) - Perceptions

    Time frame: Up to 4 months

    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).

  7. Intervention Adoption

    Time frame: Up to 1 year

    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.

  8. Intervention Implementation - Factors Influencing CSCP Fidelity

    Time frame: Up to 1 year

    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).

  9. Intervention Implementation - Perceptions

    Time frame: Up to 1 year

    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.

  10. Intervention Maintenance

    Time frame: Up to 1 year

    Staff interviews will explore anticipated facilitators and barriers to long-term implementation within standard care, including its impact on other services.

Study contacts

Contact information is provided by the study sponsor or research team.

Samantha Mayo, RN, PhD

CONTACT

[email protected]

1-437-218-0860

Stacey Morrison, MSc, CCRP

CONTACT

[email protected]

1-437-219-2807

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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