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Clinical Trials/NCT03094026
NCT03094026
Recruiting
N/A

Intervention Strategies to Improve Cognitive Functioning in Hematologic Cancer Survivors After Hematopoietic Cell Transplantation

University of Alabama at Birmingham1 site in 1 country60 target enrollmentAugust 21, 2017

Overview

Phase
N/A
Intervention
Lumosity
Conditions
Cognitive Impairment
Sponsor
University of Alabama at Birmingham
Enrollment
60
Locations
1
Primary Endpoint
Number of HCT patients completing the 2-arm wait-listed randomized trial of cognitive training intervention for a period of 3 months
Status
Recruiting
Last Updated
12 days ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
August 21, 2017
End Date
July 1, 2027
Last Updated
12 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Noha Mohamed Sharafeldin

Prinicipal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

Arms & Interventions

Intervention

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

Intervention: Lumosity

Wait List Control

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

Intervention: Lumosity (waitlist control)

Outcomes

Primary Outcomes

Number of HCT patients completing the 2-arm wait-listed randomized trial of cognitive training intervention for a period of 3 months

Time Frame: 12 weeks

Number of participants completing the 12 week intervention

Change in cognitive function between intervention and wait list control arms from baseline to 12 weeks.

Time Frame: Baseline to 12 weeks

Change in cognitive function will be measured using cognitive test scores at baseline and 12 weeks

Secondary Outcomes

  • 16-item survey to measure genetic factual knowledge at baseline(Baseline)
  • Effect size of associations of key predictors with genetic factual knowledge at baseline(Baseline)
  • 5 Likert scale survey questionnaire to measure importance of receiving genetic risk information(baseline)
  • 5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention adherence(baseline)
  • 5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention uptake(baseline)

Study Sites (1)

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