Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Remediation
Neuropsychology
Quality of Life
Psycho-Oncology
Cognitive Behavioral Therapy
Cancer Survivors
Immunotherapy
Cognitive Dysfunction
Psychological Distress
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Brugmann University Hospital
First posted: 2022-12-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
* Cohort 3: cancer survivors of a CNS tumor, who do not have active disease in the CNS

All patients of cohort 1 will receive a psychosocial and neurocognitive assessment at baseline. Patients who do not have cognitive problems or do not have interest in following the integrative neurocognitive remediation therapy program will go into the non-intervention group for follow-up.

Patients of cohort 1, 2 and 3 who have cognitive problems and/or cognitive complaints who want to follow the integrative neurocognitive remediation program will complete a neurocognitive and psychosocial assessment before and immediately after the remediation program. The same assessment will be repeated six months after finishing the therapy program, to investigate the long-term efficacy of the therapy program.
Primary purpose: SUPPORTIVE_CARE

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

Primary outcomes:
measure: Objective neurocognitive functioning measured by the COGBAT neuropsychological battery.
timeFrame: Until study completion, with an average of 3 years
measure: Subjective cognitive complaints measured by the Cognitive Failures Questionnaire.
timeFrame: Until study completion, with an average of 3 years
measure: Emotional distress as assessed by the Hospital Anxiety and Depression Scale.
timeFrame: Until study completion, with an average of 3 years
measure: Fatigue as assessed by Fatigue Severity Scale.
timeFrame: Until study completion, with an average of 3 years
measure: Fear of cancer recurrence as assessed by the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF).
timeFrame: Until study completion, with an average of 3 years
measure: Health-related quality of life as assessed by the EORTC Quality of Life Core 30 Questionnaire.
timeFrame: Until study completion, with an average of 3 years
Secondary outcomes:
measure: To document baseline demographic data, prior disease history, nature of immunotherapy therapy
timeFrame: Baseline
measure: To measure the feasibility of the implementation in a larger scale of this clinical cognitive rehabilitation program for cancer survivors, as assessed by the resources needed to implement this program.
timeFrame: Until study completion, with an average of 3 years
measure: To measure the relation between psychological distress, as assessed by the Hospital Anxiety and Depression Scale, and subjective cognitive functioning, as assessed by the Cognitive Failures Questionnaire.
timeFrame: Until study completion, with an average of 3 years
measure: To measure the relation between psychological distress, as assessed by the Hospital Anxiety and Depression Scale, and objective cognitive functioning, as assessed by the COGBAT neuropsychological battery.
timeFrame: Until study completion, with an average of 3 years
measure: To measure the relation between subjective neurocognitive functioning, as assessed by the Cognitive Failures Questionnaire, and the objective cognitive functioning, as assessed by the COGBAT neuropsychological battery.
timeFrame: Until study completion, with an average of 3 years
measure: To explore the care needs of personalized nutritional advice.
timeFrame: Until study completion, with an average of 3 years
measure: Rumination as assessed by the Brooding items of the Ruminative Response Scale (RRS).
timeFrame: Until study completion, with an average of 3 years
measure: Visuo-spatial short-term memory measured by the computerized version of the Corsi Block Tapping Test by the Vienna Test System
timeFrame: Until study completion, with an average of 3 years
measure: Verbal long-term memory measured by the California Verbal Learning Test
timeFrame: Until study completion, with an average of 3 years
measure: Information processing speed measured by the WAIS-IV Symbol Search and Coding
timeFrame: Until study completion, with an average of 3 years
measure: Verbal short-term memory measured by the WAIS-IV Digit Span Forwards
timeFrame: Until study completion, with an average of 3 years
measure: Working memory measured by the WAIS-IV Digit Span Backwards
timeFrame: Until study completion, with an average of 3 years
measure: Anxiety as assessed by the State-Trait Anxiety Inventory
timeFrame: Until study completion, with an average of 3 years
measure: Self-esteem as assessed by the Rosenberg Self-Esteem Scale.
timeFrame: Until study completion, with an average of 3 years
measure: Tendency for procrastination as assessed by the Pure Procrastination Scale.
timeFrame: Until study completion, with an average of 3 years
measure: Metacognition as assessed by the Metacognition Questionnaire.
timeFrame: Until study completion, with an average of 3 years
measure: Tendency for perfectionism as assessed by the Frost Multidimensional Perfectionism Scale.
timeFrame: Until study completion, with an average of 3 years
measure: Post-traumatic stress disorder symptoms as assessed by the PTSD checklist for DSM-5 (PCL-5).
timeFrame: Until study completion, with an average of 3 years
measure: Subjective cognitive complaints measured by the cognitive functioning subscale of the EORTC QLQ-C30.
timeFrame: Until study completion, with an average of 3 years
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: University Hospital Brugmann
state: Brussels Hoofdstedelijk Gewest
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels Hoofdstedelijk Gewest
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Bart Neyns, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: