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

NCT05667857 | Recruiting

• 1 other identifier: 2022-BN-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• Objective neurocognitive functioning measured by the COGBAT neuropsychological battery.

  To measure neurocognitive functioning (attention, memory and executive functioning), with the computerized neuropsychological test battery COGBAT. This battery gives an overall degree of objective neurocognitive functioning, in addition to the specific test performance per subtest. The test performance will be measured in raw scores and z-scores. This test battery will be repeated during follow-up for the non-intervention group. For the intervention group, the scores will be compared before and after the integrative neurocognitive remediation therapy, and 6 months thereafter. Improvement in test performance after the therapy program, compared to baseline, will indicate efficacy of the integrative neurocognitive remediation therapy program.

  Until study completion, with an average of 3 years

• Subjective cognitive complaints measured by the Cognitive Failures Questionnaire.

  To measure subjective cognitive functioning as assessed by the Cognitive Failures Questionnaire, values ranging from 0 to 100. Higher values mean more cognitive complaints. This will be repeated during follow-up for the non-intervention group. For the intervention group, the scores will be compared before and after the integrative neurocognitive remediation therapy, and 6 months thereafter. A cut-off score of 44 will be used to define elevated levels of cognitive complaints, a score higher than 54 indicates severe cognitive complaints. Improvement in subjective cognitive complaints after the therapy program, compared to baseline, will indicate efficacy of the integrative neurocognitive remediation therapy program.

  Until study completion, with an average of 3 years

• Emotional distress as assessed by the Hospital Anxiety and Depression Scale.

  To identify emotional distress, the Hospital Anxiety and Depression Scale will be used, with values ranging from 0 to 42. Higher scores mean more emotional distress. This will be repeated during follow-up for the non-intervention group. For the intervention group, the scores will be compared before and after the integrative neurocognitive remediation therapy, and 6 months thereafter. A cut-off score of 8 will be used to define elevated levels of emotional distress, a score higher than 10 corresponds to moderate emotional distress, a score higher than 14 corresponds to severe emotional distress.

  Until study completion, with an average of 3 years

• Fatigue as assessed by Fatigue Severity Scale.

  To identify fatigue, the Fatigue Severity Scale will be used. Mean scores will be calculated, leading to a score between 1 and 7. Higher values indicate more fatigue. This will be repeated during follow-up for the non-intervention group. For the intervention group, the scores will be compared before and after the integrative neurocognitive remediation therapy, and 6 months thereafter. A cut-off score of 4 will be used to define elevated levels of fatigue.

  Until study completion, with an average of 3 years

• Fear of cancer recurrence as assessed by the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF).

  To identify fear of cancer recurrence, the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF). will be used. Values range from 0 to 36 and higher values indicate more fear of cancer recurrence. This will be repeated during follow-up for the non-intervention group. For the intervention group, the scores will be compared before and after the integrative neurocognitive remediation therapy, and 6 months thereafter. A cut-off score of 13 will be used to define significant fear of cancer recurrence. A score higher than 15 equals clinically significant fear of cancer recurrence, a score higher than 21 equals a pathological fear of cancer recurrence.

  Until study completion, with an average of 3 years

• Health-related quality of life as assessed by the EORTC Quality of Life Core 30 Questionnaire.

  To measure health-related quality of life, the EORTC Quality of Life Questionnaire (EORTC-QLQ-C30) will be used. Transformed scores range between 0 and 100, higher scores indicate better health-related quality of life. This will be repeated during follow-up for the non-intervention group. For the intervention group, the scores will be compared before and after the integrative neurocognitive remediation therapy, and 6 months thereafter. The scores will be compared to the Threshold of Clinical Importance, developed by Giesinger et al. (2020). To evaluate change over time, the changes of at least 10 points are regarded, which are supported to be clinically meaningful changes (Snyder et al., 2014).

  Until study completion, with an average of 3 years

Secondary Outcomes (19)

• To document baseline demographic data, prior disease history, nature of immunotherapy therapy

  Baseline

• 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.

  Until study completion, with an average of 3 years

• 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.

  Until study completion, with an average of 3 years

• 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.

  Until study completion, with an average of 3 years

• 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.

  Until study completion, with an average of 3 years

Study Arms (2)

Non-intervention group

NO INTERVENTION

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

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.

Behavioral: Integrative neurocognitive remediation therapy

Interventions

Integrative neurocognitive remediation therapy BEHAVIORAL

Integrative Neurocognitive Remediation Therapy is a clinical program of 12 weeks (1 day/week) that combines personalized computerized cognitive training and neurocognitive strategy training, with group sessions of adapted physiotherapy, acceptance and commitment therapy (ACT), cognitive behavioral therapy (CBT) and information sessions on cognition, fatigue, nutrition and physical exercise.

Integrative neurocognitive remediation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Brugmann University Hospital: collaborator

Study Sites (2)

University Hospital Brugmann

Brussels, Brussels Capital, 1020, Belgium

RECRUITING

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Bart Neyns, MD, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Vanlaer, MSc

CONTACT

+32(0)24763979; nathalie.vanlaer@uzbrussel.be

Anne Rogiers, MD, PhD

CONTACT

+32(0)24772706; anne.rogiers@chu-brugmann.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: December 29, 2022
• Study Start: July 13, 2022
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 1, 2033
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)