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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Cognitive Intervention at the End of Therapy for Survivors of Childhood ALL Treated on TOTXVI: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03187977
• Other study ID #: ALLCOG
• Secondary ID: NCI-2017-01276
• Status: Completed
• Phase: N/A
• Start date: August 3, 2017
• Est. completion date: October 13, 2021

Study information

• Verified date: March 2022
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Participants enrolled on the TOTXVI protocol at SJCRH will be randomized to either complete the Cogmed intervention at the end of their therapy, or to a standard-of-care condition.

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. Training is completed at home in 25 sessions for 15-45 minutes each weekday for 5-9 weeks. A research team member serves as a coach who monitors progress and provides support through weekly phone calls with study participants and their parents/guardians. Information regarding compliance and performance is tracked over the internet and used to tailor feedback during weekly telephone coaching.

Neurocognitive assessments will be conducted at baseline, immediate-post (3-4 months after baseline), and 8 month follow-up (12 months after baseline).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 13, 2021
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Behavioral:
• Cognitive training
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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)

External Links

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