Cognitive Training Intervention and Attitudes Towards Genetics

Not Applicable

Recruiting

• Conditions: Cognitive Impairment; Hematologic Neoplasms; Hematopoietic Cell Transplant
• Interventions: Behavioral: Lumosity; Behavioral: Lumosity (waitlist control)

• Registration Number: NCT03094026
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-29
• Study Start: 2017-08-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Lumosity	The arm will begin the Lumosity program at enrollment in the study.
Wait List Control	Lumosity (waitlist control)	The arm will begin the Lumosity program 3 months after enrollment in the study.

Primary Outcome Measures

Name	Time	Method
Number of HCT patients completing the 2-arm wait-listed randomized trial of cognitive training intervention for a period of 3 months	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.	Baseline to 12 weeks	Change in cognitive function will be measured using cognitive test scores at baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
16-item survey to measure genetic factual knowledge at baseline	Baseline	Genetic factual knowledge will be measured using a 16-item survey on knowledge about genes, chromosomes, cells, and diseases and how different characteristics are inherited from parents.
Effect size of associations of key predictors with genetic factual knowledge at baseline	Baseline	Effect size of associations of sociodemographic characteristics such as age, gender, race/ethnicity, education and income levels with genetic factual knowledge of participants will be measured.
5 Likert scale survey questionnaire to measure importance of receiving genetic risk information	baseline	Patient ratings will be collected on a 5 Likert scale survey questionnaire to examine importance of receiving information on genetic risk of cognitive impairment post-HCT.
5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention adherence	baseline	Patient ratings will be collected on a 5 Likert scale survey questionnaire to measure association of likelihood of genetic risk of cognitive impairment (low chance vs high chance) on intervention adherence.
5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention uptake	baseline	Patient ratings will be collected on a 5 Likert scale survey questionnaire to measure association of likelihood of genetic risk of cognitive impairment (low chance vs high chance) on intervention uptake.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States