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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

ConditionsCognitive RemediationNeuropsychologyQuality of LifePsycho-OncologyCognitive Behavioral TherapyCancer SurvivorsImmunotherapyCognitive DysfunctionPsychological Distress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Non-intervention groupNo intervention 0 interventions
Group B: Integrative neurocognitive remediation therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Until study completion, with an average of 3 years
2

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.

Time frame
Until study completion, with an average of 3 years
3

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.

Time frame
Until study completion, with an average of 3 years
4

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.

Time frame
Until study completion, with an average of 3 years

Secondary outcomes

1

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

To document baseline demographic data, prior disease history, nature of immunotherapy therapy, the investigators will look into the patient medical record and a general questionnaire will be used.

Time frame
Baseline
2

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.

To explore the feasibility of the implementation in a larger scale of this clinical program will be assessed by the care need of the patients and the possibility to implement the therapy program in other hospitals (resources needed, cost of the program for the patient).

Time frame
Until study completion, with an average of 3 years
3

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.

Psychological distress will be measured by the sum scores of the Hospital Anxiety and Depression Scale. Subjective cognitive functioning will be measured by the sum scores of the Cognitive Failures Questionnaire. To measure the relation between the two variables, the investigators will conduct a statistical correlation of these outcomes. The outcome will be a correlation coefficient (r).

Time frame
Until study completion, with an average of 3 years
4

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.

Psychological distress will be measured by the sum scores of the Hospital Anxiety and Depression Scale. Objective cognitive functioning will be measured by the COGBAT neuropsychological battery. To measure the relation between the two variables, the investigators will conduct a statistical correlation of these outcomes. The outcome will be a correlation coefficient (r).

Time frame
Until study completion, with an average of 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitair Ziekenhuis Brussel

Lead sponsor

Brugmann University Hospital

Collaborator

Source ClinicalTrials.gov
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