Goal Management Training for Adult Survivors of Childhood Leukemia and Non-Hodgkins Lymphoma With… (NCT04541056) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Goal Management Training for Adult Survivors of Childhood Leukemia and Non-Hodgkins Lymphoma With Neurocognitive Sequelae
Norway60 participantsStarted 2020-09-04
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Behavior Rating Inventory of Executive Function, Adult (BRIEF-A)
Timeframe: 6 months
Trial details
NCT IDNCT04541056
SponsorNorwegian University of Science and Technology