Feasibility of a Cognitive Stepped Care Program for Adults With Brain Metastases (NCT07355348)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Princess Margaret Cancer Centre, University Health Network — Toronto, Ontario
Age range: 18 Years
🧪 Interventions in This Study
- Cognitive Stepped Care Program (CSCP) (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Princess Margaret Cancer Centre, University Health Network — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (437) 218-0860
Email: samantha.mayo@uhn.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Brain Metastases
- Preop fSRS for Resectable Brain Metastases — Tampa, Florida
- Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases — Washington D.C., District of Columbia
- Study Assessing QBS72S For Treating Brain Metastases — Palo Alto, California
- A Pilot Study to Assess the Clinical Utility of 18F-Fluciclovine (Axumin) PET-CT for Detecting True-versus Pseudo-Progression of Brain Metastases on Immunotherapy — Houston, Texas
- Neurocognitive Decline in Patients With Brain Metastases — Dallas, Texas
- MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases — Durham, North Carolina
Explore by condition: All Brain Metastases clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.