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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Emotional distress as assessed by the Hospital Anxiety and Depression Scale.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Non-intervention group
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
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.
干预措施: Integrative neurocognitive remediation therapy (Behavioral)
结局指标
主要结局
Emotional distress as assessed by the Hospital Anxiety and Depression Scale.
时间窗: Until study completion, with an average of 3 years
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.
Health-related quality of life as assessed by the EORTC Quality of Life Core 30 Questionnaire.
时间窗: Until study completion, with an average of 3 years
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).
Objective neurocognitive functioning measured by the COGBAT neuropsychological battery.
时间窗: Until study completion, with an average of 3 years
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.
Subjective cognitive complaints measured by the Cognitive Failures Questionnaire.
时间窗: Until study completion, with an average of 3 years
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.
Fatigue as assessed by Fatigue Severity Scale.
时间窗: Until study completion, with an average of 3 years
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.
Fear of cancer recurrence as assessed by the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF).
时间窗: Until study completion, with an average of 3 years
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.
次要结局
- Verbal long-term memory measured by the California Verbal Learning Test(Until study completion, with an average of 3 years)
- 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 objective cognitive functioning, as assessed by the COGBAT neuropsychological battery.(Until study completion, with an average of 3 years)
- Information processing speed measured by the WAIS-IV Symbol Search and Coding(Until study completion, with an average of 3 years)
- Verbal short-term memory measured by the WAIS-IV Digit Span Forwards(Until study completion, with an average of 3 years)
- Working memory measured by the WAIS-IV Digit Span Backwards(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 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)
- To explore the care needs of personalized nutritional advice.(Until study completion, with an average of 3 years)
- Rumination as assessed by the Brooding items of the Ruminative Response Scale (RRS).(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(Until study completion, with an average of 3 years)
- Anxiety as assessed by the State-Trait Anxiety Inventory(Until study completion, with an average of 3 years)
- Self-esteem as assessed by the Rosenberg Self-Esteem Scale.(Until study completion, with an average of 3 years)
- Tendency for procrastination as assessed by the Pure Procrastination Scale.(Until study completion, with an average of 3 years)
- Metacognition as assessed by the Metacognition Questionnaire.(Until study completion, with an average of 3 years)
- Post-traumatic stress disorder symptoms as assessed by the PTSD checklist for DSM-5 (PCL-5).(Until study completion, with an average of 3 years)
- Subjective cognitive complaints measured by the cognitive functioning subscale of the EORTC QLQ-C30.(Until study completion, with an average of 3 years)
- Tendency for perfectionism as assessed by the Frost Multidimensional Perfectionism Scale.(Until study completion, with an average of 3 years)
研究者
Bart Neyns
Prof. Dr.
Universitair Ziekenhuis Brussel