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Childhood Non-Hodgkin LymphomaNCT04541056

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

A study testing Goal Management Training (GMT) and Brain Health Workshop (BHW) in people with Childhood Non-Hodgkin Lymphoma and Childhood Acute Lymphoblastic Leukemia, run by Norwegian University of Science and Technology at 3 sites in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 years
What is being tested?
Goal Management Training (GMT) and Brain Health Workshop (BHW)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesNorway
Study dates
4 Sep 2020to Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Screening/baseline:
  • Written informed consent
  • ≥5 years from diagnosis
  • Age 18-40
  • Without cancer recurrence the last five years
  • Understand and speak Norwegian
Show all 9Show fewer
  • 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)

Who cannot join

  • 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 locations and contacts

3 sites in 1 country.

Norway3 sites

  • Oslo University Hospital - Rikshospitalet

    Oslo, 4950

  • St. Olavs Hospital

    Trondheim, 3250

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

    Trondheim, 7491

Other trials in Norway

About this study

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

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.

Read the 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).

Being tested
Goal Management Training (GMT), Brain Health Workshop (BHW)
Keywords
Adult survivor, Childhood, Cognitive Remediation, Executive Function, Cognitive Rehabilitation, Cognitive Training, Metacognitive, Late effects, Goal Management Training, Cancer
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Goal Management Training (GMT)Behavioural

    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.

  • Brain Health Workshop (BHW)Behavioural

    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.

Study groups in NCT04541056
Study groupRoleWhat they receive
Goal Management Training (GMT)ExperimentalGMT 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.
Receives: Behavioral: Goal Management Training (GMT)
Waitlist/Brain Health Workshop (BHW)Active comparatorThe 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.
Receives: Behavioral: Brain Health Workshop (BHW)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 6 months

Secondary outcomes (8)

  1. Conner's Continuous Performance Test (CPT-3)

    The CPT 3 is a measure of inattention, impulsivity, sustained attention and vigilance. The test is computer based and lasts approximately 14 minutes. The participant is instructed to press the space bar/computer mouse when letters appear, but not when Xs appear on the screen. Higher scores reflect worse performance, and raw scores are converted to T-scores (M=50, SD=10). However, scores will be recoded so that higher scores equal better performance/lower scores equal worse performance.

    Measured: 6 months

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

    The CWI is a measure of inhibition and cognitive flexibility. The test consists of four conditions; color naming (condition 1), word reading (condition 2), inhibition (condition 3) and inhibition switching (condition 4). Scores are computed for completion time (condition 1-4) and total errors (condition 3 and 4). Higher scores reflect better performance, and raw scores are converted to scaled scores (M=10, SD=3).

    Measured: 6 months

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

    The TMT from Delis Kaplan Executive Function System is a measure of flexibility/shifting. The primary measure is condition 4 where the participant is asked to shift between number and letter sequencing. The test also measures the basic abilities of visual scanning (condition 1), number- and letter sequencing combined with drawing a line (condition 2 and 3) and motor pace (Condition 5). Scores reflect completion time and raw scores are converted to scaled scores (M=10, SD=3). Higher scores reflect better performance.

    Measured: 6 months

  4. California Verbal Learning Test (CVLT II)

    The CVLT II a measure of verbal learning and memory. Participants are asked to recall words from list A, both with and without an interruption list B. There are three types of conditions; the participant is asked to freely recall items (free recall), to recall after a cue is presented (cued recall) and to recognize previously presented words (recognition condition). Both short and long delay is measured. Raw scores are converted to Z-scores (M=0, SD=1) and T-scores (M=50, SD=10). Higher scores reflect better performance, except for error measures. For T2 (14 days) follow up, CVLT II Alternative Form will be used.

    Measured: 6 months

  5. Wisconsin Card Sorting Test (WCST-64)

    The WCST-64 is a measure of abstract thinking and set-shifting/ mental flexibility. The participant is instructed to sort cards according to varying principles. A computer-based version will be employed. Raw scores are converted to T-scores (M=50, SD=10) and higher scores reflect better performance.

    Measured: 6 months

  6. The Hotel Task

    The Hotel Task is a measure of executive components: planning, organization, self-monitoring and cognitive flexibility. The participant is asked to try out as many as possible of five tasks within a relatively short (15 minutes) time period. Raw scores are computed. Higher scores reflect better performance, except for deviation of optimal time use. The test has been demonstrated to have high ecological validity and ability to detect frontal lobe dysfunction.

    Measured: 6 months

  7. The Dysexecutive Questionnaire (DEX - self-report)

    The DEX - self-report is a measure of everyday problems with executive function. The questionnaire consists of 20 items with a 5-point Likert scale where the respondent is asked to rate the frequency of cognitive difficulties from 0 (never) to 4 (very often). A higher total score reflects worse executive functioning.

    Measured: 6 months

  8. Wechsler Adult Intelligent Scale-IV - Fourth Edition (WAIS-IV)

    The subtests: Digit span, letter-number sequencing performance will be used as a measure of Verbal working memory/attention (Working memory index).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2020
  2. Study start4 Sep 2020
  3. Primary completionFeb 2026 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04541056
Sponsor's protocol ID
2018/1810
Status last verified
Aug 2025
First submitted
1 Sep 2020
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Undecided

Publications

  • 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.

    PubMed 39552427

Questions about this trial

What is this clinical trial studying?

A study testing Goal Management Training (GMT) and Brain Health Workshop (BHW) in people with Childhood Non-Hodgkin Lymphoma and Childhood Acute Lymphoblastic Leukemia, run by Norwegian University of Science and Technology at 3 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Behavior Rating Inventory of Executive Function, Adult (BRIEF-A) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04541056, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

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