Cognitive Intervention at the End of Therapy for Survivors of Childhood ALL Treated on TOTXVI

NCT03187977 | Completed

• 2 other identifiers: ALLCOGNCI-2017-01276
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Computer-based cognitive training has been found to be helpful for improving attention and working memory in pediatric and adult patients with existing cognitive difficulties. A previous study was conducted at St. Jude Children's Research Hospital with survivors of childhood cancer who were experiencing difficulties with attention and/or working memory. Findings from that study indicated that the use of Cogmed, computer-based cognitive training, is effective in improving attention and working memory in survivors. Researchers want to learn whether Cogmed intervention completed at the end of therapy for acute lymphoblastic leukemia will be effective for all survivors (i.e., regardless of whether they have existing difficulties). PRIMARY OBJECTIVES:

• To evaluate the overall participation rate in a randomized, standard-of-care controlled trial of computerized cognitive intervention administered at the end of TOTXVI therapy.
• To estimate the study completion rate in a randomized, standard-of-care controlled trial of computerized cognitive intervention administered at the end of TOTXVI therapy.
• To estimate the compliance rate for participants randomized to the intervention arm of a computerized cognitive intervention administered at the end of TOTXVI therapy.
• To estimate the standard deviation for the overall cohort on a measure of working memory.
• To use neuroimaging data collected in the context of the Total Therapy XVI trial to explore candidate biomarkers predictive of response to the computerized cognitive intervention.

Conditions

Acute Lymphoblastic Leukemia

Keywords

Cognitive intervention; Survivors; Childhood ALL

Outcome Measures

Primary Outcomes (1)

• Change in working memory

  The magnitude and standard deviation of pre- to post-change in Spatial Span Backward will be estimated for each group and for the overall group.

  Prior to intervention (baseline) and post intervention (up to one year later)

Study Arms (2)

Cognitive Training

ACTIVE COMPARATOR

Participants will participate in computer-based cognitive training at the end of therapy.

Behavioral: Cognitive training

Standard-of-Care

NO INTERVENTION

At the end of therapy, participants will participate in the current standard-of-care which does not include computer-based cognitive training.

Interventions

Cognitive training BEHAVIORAL

Cogmed is a computer-based cognitive training program that consists of rotating exercises that train attention and working memory. The exercises are presented in a child-friendly, game-like format. The program is completed at home for 15-45 minutes each weekday for 5-9 weeks.

Also known as: Cogmed

Cognitive Training

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently enrolled and receiving treatment for acute lymphoblastic leukemia (ALL) on the TOTXVI therapy protocol at St. Jude Children's Research Hospital
• At least 4 years of age at the time of randomization
• Primary language is English
• Parent/legal guardian/caregiver that speaks English available to assist in participant's training

You may not qualify if:

• Significant cognitive impairment as determined by either an IQ of ≤ 70 or by clinician judgment
• Major sensory or motor impairment that would preclude valid cognitive testing
• Major psychological condition that would preclude completion of the intervention
• History of significant CNS injury or disease predating or unrelated to cancer diagnosis
• Documented ADHD predating cancer diagnosis

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Lisa M. Jacola, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study examiner (clinical research assistants or psychological examiners) will not know which group of participants is associated with each arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either the intervention group to receive cognitive training or to the standard of care group who will not receive cognitive training.

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 15, 2017
• Study Start: August 3, 2017
• Primary Completion: October 13, 2021
• Study Completion: October 13, 2021
• Last Updated: March 28, 2022

Record last verified: 2022-03

Locations

US (1)