NCT05667857 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
| NCT ID | NCT05667857 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Cognitive Remediation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-07-13 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-07-13 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Since 2010, the field of immunotherapy has grown substantially, leading to a growing population of long-term cancer survivors treated with immunotherapy. Since cancer survivorship in immunotherapy is an emerging field, to date not much is known about psychosocial and neurocognitive survivorship-related issues in advanced cancer survivors treated with immunotherapy. Preliminary findings indicated significant psychosocial and cognitive problems in survivors of advanced melanoma persist after treatment with immunotherapy. The objective for this project is twofold. First, the investigators want to longitudinally identify survival-related problems in survivors of advanced cancer treated with immunotherapy. The second goal is to identify the efficacy of an Integrative Neuro-Cognitive Remediation Therapy (INCRT) program. The investigators will focus on the following outcomes: (1) Psychosocial consequences, such as emotional complaints, fatigue, fear of recurrence, (2) neurocognitive functioning, and (3) health-related quality of life. The INCRT combines personalized computerized cognitive training and neurocognitive strategy training, with group sessions of exercise, mindfulness, Acceptance and Commitment Therapy, and cognitive behavioral therapy. We will have three cohorts: * Cohort 1: advanced cancer survivors treated with immunotherapy * Cohort 2: cancer survivors treated with cancer therapy of any kind (excluded immunotherapy), and who have subjective complaints and/or objective cognitive impairment * Cohort 3: cancer survivors of a central nervous system (CNS) tumor, who do not have active disease in the CNS, and who have subjective complaints and/or objective cognitive impairment In the first part of the study, survival-related problems will be evaluated in cohort 1, in a longitudinal manner by means of a semi-structured interview at baseline, various questionnaires and a computerized neuropsychological test battery. In the second part of the study, patients of cohort 1, 2 and 3 with subjective or objective cognitive dysfunction can follow the INCRT program. The efficacy of the INCRT is evaluated through a pre-INCRT and post-INCRT evaluation. This evaluation consist of several questionnaires and neuropsychological tests. Long-term efficacy will be evaluated by a follow-up evaluation six months after completion of the INCRT program.
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
Contact & Investigator
Bart Neyns, MD, PhD
PRINCIPAL INVESTIGATOR
Universitair Ziekenhuis Brussel
Frequently Asked Questions
Who can join the NCT05667857 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cognitive Remediation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05667857 currently recruiting?
Yes, NCT05667857 is actively recruiting participants. Contact the research team at nathalie.vanlaer@uzbrussel.be for enrollment information.
Where is the NCT05667857 trial being conducted?
This trial is being conducted at Brussels, Belgium, Brussels, Belgium.
Who is sponsoring the NCT05667857 clinical trial?
NCT05667857 is sponsored by Universitair Ziekenhuis Brussel. The principal investigator is Bart Neyns, MD, PhD at Universitair Ziekenhuis Brussel. The trial plans to enroll 100 participants.