Goal Management Training for Adult Survivors of Childhood Leukemia and Non-Hodgkins Lymphoma With Neurocognitive Sequelae

  • STATUS
    Recruiting
  • End date
    Dec 20, 2024
  • participants needed
    60
  • sponsor
    Norwegian University of Science and Technology
Updated on 20 June 2022

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.

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).

Details
Condition Childhood Non-Hodgkin Lymphoma, Childhood Acute Lymphoblastic Leukemia, Childhood Acute Myeloid Leukemia
Treatment Goal Management Training (GMT), Brain Health Workshop (BHW)
Clinical Study IdentifierNCT04541056
SponsorNorwegian University of Science and Technology
Last Modified on20 June 2022

Eligibility

Yes No Not Sure

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
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