Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
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

Led by Universitair Ziekenhuis Brussel · Updated on 2025-01-20

100

Participants Needed

2

Research Sites

594 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

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.

CONDITIONS

Official 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 disease for therapy groups
  • Have received any cancer therapy
  • Completed cancer treatment except ongoing adjuvant hormone therapy
  • Dutch or French speaking for therapy group
Not Eligible

You will not qualify if you...

  • Severe non-cancer 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

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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

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Research Team

N

Nathalie Vanlaer, MSc

CONTACT

A

Anne Rogiers, MD, PhD

CONTACT

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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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 | DecenTrialz