Assessing cognitive and quality of life issues in advanced cancer survivors treated with immunotherapy
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
NA · Universitair Ziekenhuis Brussel · NCT05667857
This study is testing a new therapy to see if it can help advanced cancer survivors who have received immunotherapy improve their mental health and cognitive challenges.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Brussels, Brussels Capital and 1 other locations) |
| Trial ID | NCT05667857 on ClinicalTrials.gov |
What this trial studies
This study aims to longitudinally evaluate the psychosocial and neurocognitive challenges faced by advanced cancer survivors who have undergone immunotherapy. It will identify survival-related problems and assess the effectiveness of an Integrative Neuro-Cognitive Remediation Therapy (INCRT) program. The focus will be on outcomes such as emotional well-being, fatigue, fear of recurrence, and cognitive function. Participants will include those with confirmed normalization on PET scans and varying degrees of cognitive impairment.
Who should consider this trial
Good fit: Ideal candidates are advanced cancer survivors who have completed immunotherapy at least one year ago and are experiencing cognitive issues.
Not a fit: Patients with severe non-cancer-related psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life and cognitive function for advanced cancer survivors treated with immunotherapy.
How similar studies have performed: While the approach of integrating neurocognitive remediation therapy is relatively novel, preliminary findings suggest that psychosocial and cognitive issues in cancer survivors are significant, indicating a need for such interventions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brussels, Brussels Capital and 1 other locations
- University Hospital Brugmann — Brussels, Brussels Capital, Belgium (RECRUITING)
- Universitair Ziekenhuis Brussel — Brussels, Brussels Capital, Belgium (RECRUITING)
Study contacts
- Principal investigator: Bart Neyns, MD, PhD — Universitair Ziekenhuis Brussel
- Study coordinator: Nathalie Vanlaer, MSc
- Email: nathalie.vanlaer@uzbrussel.be
- Phone: +32(0)24763979
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cognitive Remediation, Neuropsychology, Quality of Life, Psycho-Oncology, Cognitive Behavioral Therapy, Cancer Survivors, Immunotherapy, Cognitive Dysfunction