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
Launched by UNIVERSITAIR ZIEKENHUIS BRUSSEL · Dec 27, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the experiences and challenges faced by advanced cancer survivors who have been treated with immunotherapy, a type of cancer treatment that helps the immune system fight cancer. Researchers want to understand the emotional and mental health issues these survivors may encounter, such as stress, fatigue, and concerns about their cancer returning. The trial also aims to evaluate a new therapy called Integrative Neuro-Cognitive Remediation Therapy (INCRT), which combines computer-based cognitive exercises with group sessions focusing on mindfulness, physical activity, and psychological support. This therapy could help improve mental function and overall quality of life for participants.
To participate, individuals must be advanced cancer survivors who began immunotherapy at least a year ago and are currently cancer-free, or they must have had other types of cancer treatments and have cognitive complaints. Participants will go through interviews and questionnaires to assess their mental health and cognitive abilities. Those who show signs of cognitive difficulties may join the INCRT program, where their progress will be tracked before and after the therapy, as well as six months later. This study is open to adults aged 65 and older, and it aims to provide valuable insights into improving the well-being of cancer survivors.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- 1. Non-intervention group:
- • Provision of written informed consent
- • Diagnosed with advanced cancer of any type
- • Initiated immunotherapy (Anti-PD1, Anti-PDL1, CTLA-4, ...) at least one year ago
- • Have a confirmed normalization on whole-body 18F-FDG PET
- • English, Dutch or French-speaking
- 2. Integrative neurocognitive remediation therapy group:
- • Provision of written informed consent
- • Objective cognitive impairment and/or subjective cognitive complaints
- • Confirmed normalization on whole-body 18F-FDG PET for patients (cohort 1)
- • Disease-free (cohort 2) or no active disease for patients with CNS tumors (cohort 3)
- • Having received a cancer therapy of any kind
- • Having ended cancer treatment (immunotherapy, chemotherapy, radiotherapy, surgery, ...) with an exception of ongoing adjuvant hormone therapy
- • Dutch or French speaking
- Exclusion Criteria:
- • severe co-morbid non cancer-related psychiatric disorders such as psychosis, obsessive compulsive disorders, eating disorders etc., patients with cognitive impairment related to dementia, and patients that are physically or mentally not able to fill in the questionnaires
About Universitair Ziekenhuis Brussel
Universitair Ziekenhuis Brussel (UZ Brussel) is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution affiliated with the Vrije Universiteit Brussel, UZ Brussel integrates cutting-edge medical research with high-quality patient care. The hospital's multidisciplinary teams are dedicated to exploring novel therapeutic approaches and contributing to the development of evidence-based treatments, ensuring the highest standards of safety and efficacy in clinical research. With a strong focus on collaboration and knowledge dissemination, UZ Brussel plays a pivotal role in shaping the future of medicine and improving patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brussel, Brussels Hoofdstedelijk Gewest, Belgium
Brussel, Brussels Hoofdstedelijk Gewest, Belgium
Patients applied
Trial Officials
Bart Neyns, MD, PhD
Principal Investigator
Universitair Ziekenhuis Brussel
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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