Cognitive Training Intervention and Attitudes Towards Genetics

NCT ID: NCT03094026

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-21

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cognitive Impairment Hematologic Neoplasms Hematopoietic Cell Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

The arm will begin the Lumosity program at enrollment in the study.

Group Type EXPERIMENTAL

Lumosity

Intervention Type BEHAVIORAL

Computer-based online cognitive training program using the Lumosity cognitive training program.

Wait List Control

The arm will begin the Lumosity program 3 months after enrollment in the study.

Group Type ACTIVE_COMPARATOR

Lumosity (waitlist control)

Intervention Type BEHAVIORAL

Computer-based online cognitive training program using the Lumosity cognitive training program. The control group will receive the intervention after a waiting period of 12 weeks.

Interventions

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Lumosity

Computer-based online cognitive training program using the Lumosity cognitive training program.

Intervention Type BEHAVIORAL

Lumosity (waitlist control)

Computer-based online cognitive training program using the Lumosity cognitive training program. The control group will receive the intervention after a waiting period of 12 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Noha Mohamed Sharafeldin

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noha M Sharafeldin

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Noha M Sharafeldin, MD,MSc, PhD

Role: CONTACT

2056382144

Lindsey Hageman, MPH

Role: CONTACT

2056382139

Facility Contacts

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Noha Sharafeldin, MD, MSc, PhD

Role: primary

2056382144

Lindsey Hageman, MPH, CCRP

Role: backup

2056382139

Other Identifiers

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X161221006

Identifier Type: -

Identifier Source: org_study_id

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