Clinical trial NCT04541056: Goal Management Training for Adult Survivors of Childhood Leukemia and Non-Hodgkins Lymphoma With Neurocognitive Sequelae
Official title: The Effect of Goal Management Training for Adult Survivors of Childhood Leukemia and Non-Hodgkins Lymphoma With Neurocognitive Sequelae: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Childhood Non-Hodgkin Lymphoma
Childhood Acute Lymphoblastic Leukemia
Childhood Acute Myeloid Leukemia
Keywords: Adult survivor
Childhood
Cognitive Remediation
Executive Function
Cognitive Rehabilitation
Cognitive Training
Metacognitive
Late effects
Goal Management Training
Cancer
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Oslo University Hospital
name: Norwegian Cancer Society
First posted: 2020-09-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Behavior Rating Inventory of Executive Function, Adult (BRIEF-A)
timeFrame: 6 months
Secondary outcomes:
measure: Conner's Continuous Performance Test (CPT-3)
timeFrame: 6 months
measure: The Color-Word Interference Test (CWI), from Delis Kaplan Executive Function System
timeFrame: 6 months
measure: The Trail Making Test (TMT): from Delis Kaplan Executive Function System
timeFrame: 6 months
measure: California Verbal Learning Test (CVLT II)
timeFrame: 6 months
measure: Wisconsin Card Sorting Test (WCST-64)
timeFrame: 6 months
measure: The Hotel Task
timeFrame: 6 months
measure: The Dysexecutive Questionnaire (DEX - self-report)
timeFrame: 6 months
measure: Wechsler Adult Intelligent Scale-IV - Fourth Edition (WAIS-IV)
timeFrame: 6 months
Other outcomes:
measure: The Pediatric Quality of Life Inventory (PedsQLTM4.0) young adult version
timeFrame: 6 months
measure: The Hopkins Symptom Check List (HSCL-25)
timeFrame: 6 months
measure: The General Perceived Self-Efficacy Scale (GPSS)
timeFrame: 6 months
measure: The Fatigue Severity Scale (FSS)
timeFrame: 6 months
measure: Fatigue questionnaire (FQ)
timeFrame: 6 months
measure: The Resilience Scale for Adults (RSA)
timeFrame: 6 months
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 6 months
measure: The Insomnia Severity Index (ISI)
timeFrame: 6 months
measure: PROMIS Pain Interference (PPI)
timeFrame: 6 months
measure: Brief Pain Inventory (BPI)
timeFrame: 6 months
measure: Semi-structured interview
timeFrame: 6 months
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital - Rikshospitalet
city: Trondheim
country: Norway
facility: St. Olavs Hospital
city: Trondheim
country: Norway
facility: Department of Psychology, Norwegian University of Science and Technology (NTNU)
Study officials:
affiliation: Norwegian University of Science and Technology
name: Magne Arve Flaten, phd prof
role: STUDY_DIRECTOR
affiliation: St. Olavs Hospital, Clinic manager
name: Paul Georg Skogen
role: STUDY_DIRECTOR
References: