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

Обзор

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.

Вмешательства

• Поведенческое Integrative neurocognitive remediation therapy
  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.

Первичные конечные точки

• Objective neurocognitive functioning measured by the COGBAT neuropsychological battery. [Срок оценки: Until study completion, with an average of 3 years]
• Subjective cognitive complaints measured by the Cognitive Failures Questionnaire. [Срок оценки: Until study completion, with an average of 3 years]
• Emotional distress as assessed by the Hospital Anxiety and Depression Scale. [Срок оценки: Until study completion, with an average of 3 years]
• Fatigue as assessed by Fatigue Severity Scale. [Срок оценки: 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). [Срок оценки: 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. [Срок оценки: Until study completion, with an average of 3 years]

Вторичные конечные точки (12)

• To document baseline demographic data, prior disease history, nature of immunotherapy therapy [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Until study completion, with an average of 3 years]
• To explore the care needs of personalized nutritional advice. [Срок оценки: Until study completion, with an average of 3 years]
• Rumination as assessed by the Brooding items of the Ruminative Response Scale (RRS). [Срок оценки: Until study completion, with an average of 3 years]
• Visuo-spatial short-term memory measured by the computerized version of the Corsi Block Tapping Test by the Vienna Test System [Срок оценки: Until study completion, with an average of 3 years]
• Verbal long-term memory measured by the California Verbal Learning Test [Срок оценки: Until study completion, with an average of 3 years]
• Information processing speed measured by the WAIS-IV Symbol Search and Coding [Срок оценки: Until study completion, with an average of 3 years]
• Verbal short-term memory measured by the WAIS-IV Digit Span Forwards [Срок оценки: Until study completion, with an average of 3 years]
• Working memory measured by the WAIS-IV Digit Span Backwards [Срок оценки: Until study completion, with an average of 3 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Бельгия · 2 центра

• University Hospital Brugmann — Brussels
• Universitair Ziekenhuis Brussel — Brussels

Идентификаторы

NCT: NCT05667857 · 2022-BN-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗