Actively Recruiting
Longitudinal Assessment of Cognitive, Psychosocial, and Quality of Life Effects in Advanced Cancer Survivors Treated with Immunotherapy and Evaluation of Integrative Neurocognitive Remediation Therapy
Led by Universitair Ziekenhuis Brussel · Updated on 2025-01-20
100
Participants Needed
2
Research Sites
594 weeks
Total Duration
On this page
Sponsors
U
Universitair Ziekenhuis Brussel
Lead Sponsor
B
Brugmann University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying long-term advanced cancer survivors treated with immunotherapy to better understand psychosocial and neurocognitive issues they may face. The study focuses on identifying survival-related problems such as emotional distress, fatigue, fear of cancer recurrence, cognitive functioning, and health-related quality of life. It also aims to evaluate the effectiveness of an Integrative Neuro-Cognitive Remediation Therapy (INCRT) program designed to help with these challenges. The INCRT program lasts 12 weeks with weekly sessions combining personalized computerized cognitive training and neurocognitive strategy training. Group sessions include adapted physiotherapy, mindfulness, Acceptance and Commitment Therapy, cognitive behavioral therapy, and educational information on cognition, fatigue, nutrition, and physical exercise. The study includes three cohorts: advanced cancer survivors treated with immunotherapy, survivors treated with other cancer therapies with cognitive issues, and survivors of central nervous system tumors without active disease but with cognitive complaints. Participants in cohort 1 are evaluated longitudinally using semi-structured interviews, questionnaires, and neuropsychological tests. Those from all cohorts with cognitive impairment or complaints can join INCRT, with assessments before and after therapy and a follow-up six months later. The study measures objective cognitive function, subjective complaints, emotional distress, fatigue, fear of recurrence, and quality of life, with ongoing monitoring for about three years.
CONDITIONS
Official Title
Longitudinal Neurocognitive, Psychosocial and Health-related Quality of Life Assessment in Advanced Cancer Survivors Treated With Immunotherapy and the Efficacy of Integrative Neurocognitive Remediation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provision of written informed consent
- Diagnosed with advanced cancer of any type
- Started immunotherapy (Anti-PD1, Anti-PDL1, CTLA-4, etc.) at least one year ago
- Confirmed normalization on whole-body 18F-FDG PET
- English, Dutch, or French speaking
- Objective cognitive impairment and/or subjective cognitive complaints for therapy group
- Disease-free or no active CNS disease for therapy groups
- Have received any cancer therapy
- Completed cancer treatment except ongoing adjuvant hormone therapy
- Dutch or French speaking for therapy group
You will not qualify if you...
- Severe non-cancer psychiatric disorders such as psychosis, obsessive-compulsive disorder, or eating disorders
- Cognitive impairment related to dementia
- Physically or mentally unable to complete questionnaires
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University Hospital Brugmann
Brussels, Brussels Capital, Belgium, 1020
Actively Recruiting
2
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, Belgium, 1090
Actively Recruiting
Research Team
N
Nathalie Vanlaer, MSc
A
Anne Rogiers, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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