The Effect of Goal Management Training for Adult Survivors of Childhood Leukemia and Non-Hodgkins Lymphoma With Neurocognitive Sequelae: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- The Behavior Rating Inventory of Executive Function, Adult (BRIEF-A)
研究概览
简要总结
Survivors of childhood cancer are at risk for developing neurocognitive sequelae. Multiple meta-analyses demonstrate significant deficits in overall intellectual abilities, academic functioning and specific cognitive skills among survivors of childhood cancer treated with intrathecal chemotherapy only and/or cranial irradiation. Preventing neurocognitive deficits is therefore of great importance. Unfortunately, intervention studies for this group of survivors are scarce. The main aim of this randomized controlled trial is to determine the efficacy of Goal Management Training (GMT) as a group-based treatment program for 60 adult survivors of childhood leukemia, and non Hodgkins lymphoma, diagnosed between 1980 and 2017 at an age below 18, with attention and executive function deficits. The participants will be randomized to one treatment group (GMT), and one waitlist condition followed by one active control intervention, the "Brain health workshop" (BHW), which has a psycho-educative approach. The follow-up time from diagnosis will be ≥5 years and the age at survey 18-40 years. The study will expand the knowledge base on treatment factors important in improving cognitive function. Results from this study can be implemented in rehabilitation for the young adult survivors of childhood leukemia, and non Hodgkins lymphoma, which will be of importance for their future educational and work-related functioning.
详细描述
Effect of the GMT/waitlist conditions will be assessed through self-reported and objective measures of neuropsychological function, quality of life and health measurements. To avoid extra training effects of neuropsychological testing on participants allocated to waitlist/BHW, assessment following BHW (approximately one-year post T1) will consist of self-report measures only. Patients in all groups will be reassessed within 14 days post intervention (T2), and at 6 months post intervention (T3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The Norwegian Cancer Registry will identify participants based on the following criteria:
- •Acute Lymphoblastic Leukaemia (ALL), Acute Myelogen Leukemia (AML), non Hodgkins Lymphoma diagnosed between 1980 - 2017
- •Age when diagnosed <18 år (0-17years)
- •Age at survey 18-40 years
- •Born between 1980 - 2004
- •Minimum five years (≥5) post ALL, AML, NHL diagnosis
- •ALL, AML, NHL treatment at Oslo University Hospital and St. Olavs Hospital
- •Inclusion Criteria
- •Screening/baseline:
- •Written informed consent
- •≥5 years from diagnosis
- •Age 18-40
- •Without cancer recurrence the last five years
- •Understand and speak Norwegian
- •Additional inclusion criteria for the intervention:
- •Experiencing executive dysfunction as determined by a semi-structured interview
- •Cognitive capacity to engage with the training, and General Ability Index (GAI) Score ≥70 measured by Wechsler Intelligence Scale for Adults (WAIS-IV)
排除标准
- •Cancer recurrence within the last five years
- •A history of premorbid Central Nervous System (CNS) injury or disease (e.g., Traumatic brain injury with noticeable cognitive changes, loss of consciousness or injury discovered on CT or MR)
- •Pre-existing attention deficit hyperactivity disorder (ADHD)
- •Motor or sensory damage impeding study participation
- •A major psychiatric disease and/or ongoing substance abuse impeding study participation
- •Present suicidal ideation
- •Down syndrome
研究组 & 干预措施
Goal Management Training (GMT)
GMT will be administrated in a group-based format over 5 sessions (minimum three weeks between each session). Homework assignments between sessions are included. Following the fourth session, text messages reading "Stop!" (a key instruction in GMT) will be sent to all GMT participants every day to maximize adherence to training (approximately 12 per participant). Homework assignment will also include the logging of automatic thoughts and an examination of the relationship between situations, thoughts, and accompanying emotions.
干预措施: Goal Management Training (GMT) (Behavioral)
Waitlist/Brain Health Workshop (BHW)
The adults participating in the control condition will approximately one year from waitlist, be offered a psycho-educative training program, the BHW, in groups aimed at providing a better understanding of cognitive sequelae after treatment for childhood ALL. BHW will be administrated in a group-based format over 5 sessions (minimum three weeks between each session). Homework assignments between sessions are included. Homework assignments between sessions are included.
干预措施: Brain Health Workshop (BHW) (Behavioral)
结局指标
主要结局
The Behavior Rating Inventory of Executive Function, Adult (BRIEF-A)
时间窗: 6 months
The BRIEF-A self-report questionnaire consists of 75 items on which the patient's symptoms are rated on a 3-point Likert scale. The questionnaire provides a Global Executive Composite (GEC) score (range 75-225) and two index scores: the Behavioral Regulation Index (BRI) (range 30-90) and the Metacognitive Index (MI) (range 40-120). Nine subscales are also provided: Inhibit (range 8-24), Shift (range 6-18), Emotional control (range 10-30), Self-monitor (range 6-18), Initiate (range 8-24), Working memory (range 8-24), Plan/organize (range 10-30), Task monitor (range 6-18) and Organization of materials (range 8-24). Higher scores indicate more executive difficulties. Raw scores are transformed into t scores (M=50, SD=10).
次要结局
- The Color-Word Interference Test (CWI), from Delis Kaplan Executive Function System(6 months)
- Wisconsin Card Sorting Test (WCST-64)(6 months)
- The Hotel Task(6 months)
- Conner's Continuous Performance Test (CPT-3)(6 months)
- The Trail Making Test (TMT): from Delis Kaplan Executive Function System(6 months)
- California Verbal Learning Test (CVLT II)(6 months)
- Wechsler Adult Intelligent Scale-IV - Fourth Edition (WAIS-IV)(6 months)
- The Dysexecutive Questionnaire (DEX - self-report)(6 months)