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NCT05667857
Longitudinal Neurocognitive, Psychosocial and Health-related Quality of Life Assessment in Metastatic Cancer Survivors Treated With Immunotherapy, Followed by an Integrative Neurocognitive Remediation Therapy Program
Conditions: Cognitive Remediation, Neuropsychology, Quality of Life, Psycho-Oncology, Cognitive Behavioral Therapy, Cancer Survivors, Immunotherapy, Cognitive Dysfunction, Psychological Distress
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 70
Sponsor: Universitair Ziekenhuis Brussel
Location: Belgium
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 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 metastatic 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.
In the first part of the study, survival-related problems will be evaluated in a longitudinal manner by means of various questionnaires and a computerized neuropsychological test battery.
In the second part of the study, participants with subjective or objective cognitive dysfunction can follow the INCRT.
The efficacy of the INCRT is evaluated through a pre-INCRT and post-INCRT evaluation.
Long-term efficacy will be evaluated by a follow-up evaluation six months after the INCRT.
Eligibility Criteria
Inclusion Criteria:Baseline assessment:Provision of written informed consentDiagnosed with an unresectable AJCC Stage III or IV cancer of any typeInitiated immunotherapy (Anti-PD1, Anti-PD2, CTLA-4, …) at least one year agoHave a confirmed normalization on whole-body 18F-FDG PETEnglish, Dutch or French-speakingINCRT program:All the criteria for the baseline assessmentObjective cognitive impairment and/or subjective cognitive complaintsExclusion 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
Source: ClinicalTrials.gov (NCT05667857). StuddyBuddy aggregates publicly available trial information.