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

Norwegian University of Science and Technology

Status: Active, not recruiting

Conditions: Childhood Non-Hodgkin Lymphoma; Childhood Acute Lymphoblastic Leukemia; Childhood Acute Myeloid Leukemia

Treatments: Behavioral: Goal Management Training (GMT); Behavioral: Brain Health Workshop (BHW)

Study type: Interventional

Funder types: Other

Identifiers

NCT04541056

2018/1810

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Goal Management Training (GMT)

Experimental group

Description:

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.

Treatment:

Behavioral: Goal Management Training (GMT)

Waitlist/Brain Health Workshop (BHW)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Brain Health Workshop (BHW)