Assessing cognitive and quality of life issues in advanced cancer survivors treated with immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.