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 (CognIT)

Universitair Ziekenhuis Brussel

Status: Enrolling

Conditions: Psycho-Oncology; Immunotherapy; Quality of Life; Cancer Survivors; Cognitive Dysfunction; Cognitive Remediation; Cognitive Behavioral Therapy; Neuropsychology; Psychological Distress

Treatments: Behavioral: Integrative neurocognitive remediation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05667857

2022-BN-001

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Non-intervention group

No Intervention group

Description:

These participants will a undergo a neurocognitive and psychosocial assessment at baseline, and in follow-up after 6 months and 1 year thereafter. The aim of this group is to measure the extent of psychosocial and cognitive difficulties and health-related quality of life.

Integrative neurocognitive remediation therapy

Experimental group

Description:

The experimental group will undergo profound neuropsychological and psychological assessment before starting the integrative neurocognitive remediation therapy, in addition to the assessment already done at baseline. This group will repeat the testing after completion of the integrative neurocognitive remediation therapy, and 6 months thereafter.

Treatment:

Behavioral: Integrative neurocognitive remediation therapy