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

NCT04541056 | Active Not Recruiting

• 1 other identifier: 2018/1810
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• The Behavior Rating Inventory of Executive Function, Adult (BRIEF-A)

  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).

  6 months

Secondary Outcomes (8)

• Conner's Continuous Performance Test (CPT-3)

  6 months

• The Color-Word Interference Test (CWI), from Delis Kaplan Executive Function System

  6 months

• The Trail Making Test (TMT): from Delis Kaplan Executive Function System

  6 months

• California Verbal Learning Test (CVLT II)

  6 months

• Wisconsin Card Sorting Test (WCST-64)

  6 months

Other Outcomes (11)

• The Pediatric Quality of Life Inventory (PedsQLTM4.0) young adult version

  6 months

• The Hopkins Symptom Check List (HSCL-25)

  6 months

• The General Perceived Self-Efficacy Scale (GPSS)

  6 months

Study Arms (2)

Goal Management Training (GMT)

EXPERIMENTAL

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.

Behavioral: Goal Management Training (GMT)

Waitlist/Brain Health Workshop (BHW)

ACTIVE COMPARATOR

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.

Behavioral: Brain Health Workshop (BHW)

Interventions

Goal Management Training (GMT) BEHAVIORAL

The manual comprises an introduction to GMT for the survivors of ALL, and a detailed session structure incorporating cognitive and behavioral tasks. The GMT program involves teaching the participants about goals, attention slips and how to manage these, how to review and prioritize goals (e.g., Stop, Think, Organize, Plan), and how to keep goals in mind (e.g., using analogies such as the mental blackboard). Each session will follow the same general format; namely, facility-delivered presentations, flipchart discussions, group activities and homework.

Goal Management Training (GMT)

Brain Health Workshop (BHW) BEHAVIORAL

BHW is a psycho-educative control condition, and is typically part of psycho-educative Acquired Brain Injury (ABI) rehabilitation programs, but adjusted for the ALL group of participants. The psycho-educative control condition BHW will be matched GMT for amount of training and therapist contact. Homework assignment and in-session tasks included readings, brain games, puzzles, and practical exercises such as logging sleep.

Waitlist/Brain Health Workshop (BHW)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Screening/baseline:
• Written informed consent
• ≥5 years from diagnosis
• Age 18-40
• Without cancer recurrence the last five years
• Understand and speak Norwegian
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• Oslo University Hospital: collaborator
• Norwegian Cancer Society: collaborator

Study Sites (3)

Oslo University Hospital - Rikshospitalet

Oslo, 4950, Norway

Location

St. Olavs Hospital

Trondheim, 3250, Norway

Location

Department of Psychology, Norwegian University of Science and Technology (NTNU)

Trondheim, 7491, Norway

Location

Related Publications (1)

• Egset KS, Weider S, Hjemdal O, Ruud E, Hjort MA, Eilertsen MB, Sund AM, Stubberud J, Reinfjell T. Exploring the Discrepancy Between Subjective and Objective Measures of Executive Functions in Young Adult Survivors of Childhood Acute Lymphoblastic Leukemia. J Adolesc Young Adult Oncol. 2025 Aug;14(4):345-351. doi: 10.1089/jayao.2024.0105. Epub 2024 Nov 18.

  PMID: 39552427 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Magne Arve Flaten, phd prof

  Norwegian University of Science and Technology

  STUDY DIRECTOR

• Paul Georg Skogen

  St. Olavs Hospital, Clinic manager

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 9, 2020
• Study Start: September 4, 2020
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (3)