Actively Recruiting
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
Led by Universitair Ziekenhuis Brussel · Updated on 2025-01-20
100
Participants Needed
2
Research Sites
369 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 survivors of advanced cancer who have been treated with immunotherapy to understand their psychosocial and neurocognitive challenges. This research also aims to evaluate the effectiveness of an Integrative Neuro-Cognitive Remediation Therapy (INCRT) program designed to address emotional complaints, fatigue, fear of recurrence, neurocognitive functioning, and quality of life. The study includes three groups: advanced cancer survivors treated with immunotherapy, cancer survivors treated with other therapies who have cognitive complaints, and survivors of central nervous system tumors without active disease but with cognitive issues. Participants in the study either undergo regular assessments or participate in the INCRT program. This 12-week behavioral program includes personalized computerized cognitive training, neurocognitive strategy training, and group sessions involving adapted physiotherapy, mindfulness, Acceptance and Commitment Therapy, cognitive behavioral therapy, and information on cognition, fatigue, nutrition, and physical exercise. Assessments occur at baseline, after completion of the program, and six months later to evaluate the therapy's impact. Participants will complete interviews, questionnaires, and computerized neuropsychological tests to measure cognitive function, emotional distress, fatigue, fear of cancer recurrence, and health-related quality of life. These assessments are conducted at the start, six months, and one year later for the non-intervention group, and additionally before and after the INCRT program for those in the therapy group. Researchers will monitor these outcomes longitudinally for up to three years to understand long-term effects and therapy benefits.
CONDITIONS
Brief 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 tumor disease for therapy group
- Received cancer therapy of any kind and ended treatment except ongoing adjuvant hormone therapy for therapy group
- Dutch or French speaking for therapy group
You will not qualify if you...
- Severe co-morbid non cancer-related 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo neurocognitive and psychosocial assessments to establish baseline measures of cognitive function, emotional distress, fatigue, and quality of life.
1 baseline visit (in-person)
Duration - 12 weeks
Participants in the therapy group attend a clinical program for 12 weeks, with weekly sessions combining computerized cognitive training, neurocognitive strategy training, group physiotherapy, acceptance and commitment therapy, cognitive behavioral therapy, and information sessions on cognition, fatigue, nutrition, and physical exercise.
Weekly visits for up to 12 weeks (in-person)
Duration - 1 day
Participants in the therapy group repeat neuropsychological and psychological assessments after completing the therapy program to evaluate changes in cognitive and psychosocial functioning.
1 visit (in-person)
Duration - Up to 1 year
Participants undergo follow-up testing to monitor neurocognitive, psychosocial, and quality of life outcomes over time, with assessments at 6 months and 1 year after baseline or therapy completion.
1 visit at 6 months and 1 visit at 1 year (in-person)
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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