Recruiting

Cognitive Stepped Care Program

Sponsor:

University Health Network, Toronto

Code:

NCT07355348

Conditions

Brain Metastases

Brain Metastasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Stepped Care Program (CSCP)

Study Details

Brief 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.

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.

Conditions

Brain Metastases

Brain Metastasis

Study ID

NCT07355348

Start date

Jan 9, 2026

Status verified date

Jan, 2026

Completion date

Jun, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

140 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Cognitive Stepped Care Program

Interventions

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.

Primary outcome measure

  • Intervention Completion Rate [ Time Frame: Through study completion, an average of 1 month ]
  • Intervention Satisfaction [ Time Frame: Through study completion, an average of 1 month ]
  • Descriptions of Feasibility [ Time Frame: Through study completion, an average of 1 month ]
  • Recruitment Rate [ Time Frame: Baseline ]
  • Retention Rate [ Time Frame: Through study completion, an average of 1 month ]

Central Contacts and Locations

Central contacts

Samantha Mayo, RN, PhD

1-437-218-0860samantha.mayo@uhn.ca

Stacey Morrison, MSc, CCRP

1-437-219-2807stacey.morrison@uhn.ca

Locations

Princess Margaret Cancer Centre, University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Samantha Mayo, RN, PhD

1-437-218-0860samantha.mayo@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Keywords

  • cancer-related cognitive impairment
  • brain metastases
  • brain metastasis
  • stepped care
  • symptom management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-01-21.