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Cognitive Training Intervention and Attitudes Towards Genetics (cTAG)

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Enrolling

Conditions

Hematopoietic Cell Transplant
Hematologic Neoplasms
Cognitive Impairment

Treatments

Behavioral: Lumosity (waitlist control)
Behavioral: Lumosity

Study type

Interventional

Funder types

Other

Identifiers

NCT03094026
X161221006

Details and patient eligibility

About

A pilot study to evaluate feasibility of enrollment of patients in an intervention to improve neurocognitive function in hematopoietic cell transplantation (HCT) survivors using the cognitive training Lumosity program. In addition, patients' interest in receiving information regarding genetic risk of cognitive impairment post-HCT will be measured.

Full description

The investigators propose using an "off-the-shelf" product - Lumosity (http://www.lumosity.com/) - an online cognitive training program, to address the cognitive impairment in outpatient HCT survivors. The program offers over 60 tasks in game-like format that cover the main cognitive domains: processing speed, working memory, and executive function. Training will involve a daily session of 5 training tasks for 12 weeks. Each time the patient is logged in for a session, a customized report will be generated by the Lumosity program to capture performance information.

Ideally, targeting the intervention and offering it specifically to those at highest risk (integrating clinical and genetic markers) would ensure efficacy. However, evidence is lacking on whether patients are receptive to communication of individual genetic information and whether provision of such results would lead to enhanced intervention response. To realize the high expectations of personalized medicine, patients' preferences and attitudes need to be thoroughly investigated especially as more information on genetic risk becomes available. The investigators will examine patients' genetic knowledge to determine whether factual knowledge of genetics is essential for understanding genetic risk and for informing treatment decision making in this patient population.

Enrollment

60 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥ 21 years old at time of allogeneic HCT performed at UAB
  • Outpatient and between 3 and 6 months post HCT
  • English speaking
  • Possess access to an internet-connected home computer

Exclusion criteria

  • History of pre-existing neurological disorder or documented major psychiatric disorder; significant auditory, visual, or motor impairments
  • Participated in neuropsychological intervention within the past 6 months
  • History of color blindness

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Intervention
Experimental group
Description:
The arm will begin the Lumosity program at enrollment in the study.
Treatment:
Behavioral: Lumosity
Wait List Control
Active Comparator group
Description:
The arm will begin the Lumosity program 3 months after enrollment in the study.
Treatment:
Behavioral: Lumosity (waitlist control)

Trial contacts and locations

1

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Central trial contact

Noha M Sharafeldin, MD,MSc, PhD; Lindsey Hageman, MPH

Data sourced from clinicaltrials.gov

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