Cognitive Training Intervention and Attitudes Towards Genetics

Cognitive Impairment Clinical Trial

— cTAG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03094026
• Other study ID #: X161221006
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2017
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: Noha M Sharafeldin, MD,MSc, PhD
• Phone: 2056382144
• Email: nsharaf[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Impairment
• Hematologic Neoplasms
• Hematopoietic Cell Transplant

Intervention

Behavioral:
• Lumosity
Computer-based online cognitive training program using the Lumosity cognitive training program.
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of HCT patients completing the 2-arm wait-listed randomized trial of cognitive training intervention for a period of 3 months	Number of participants completing the 12 week intervention	12 weeks
Primary	Change in cognitive function between intervention and wait list control arms from baseline to 12 weeks.	Change in cognitive function will be measured using cognitive test scores at baseline and 12 weeks	Baseline to 12 weeks
Secondary	16-item survey to measure genetic factual knowledge at 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.	Baseline
Secondary	Effect size of associations of key predictors with genetic factual knowledge at 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.	Baseline
Secondary	5 Likert scale survey questionnaire to measure importance of receiving genetic risk information	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.	baseline
Secondary	5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention uptake	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.	baseline
Secondary	5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention adherence	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.	baseline