Cognitive Training Intervention and Attitudes Towards Genetics (cTAG)

April 8, 2024 updated by: Noha Mohamed Sharafeldin, University of Alabama at Birmingham

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Noha M Sharafeldin, MD,MSc, PhD
  • Phone Number: 2056382144
  • Email: nsharaf@uab.edu

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Contact:
          • Noha Sharafeldin, MD, MSc, PhD
          • Phone Number: 205-638-2144
          • Email: nsharaf@uab.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The arm will begin the Lumosity program at enrollment in the study.
Behavioral: Lumosity
Computer-based online cognitive training program using the Lumosity cognitive training program.
Active Comparator: Wait List Control
The arm will begin the Lumosity program 3 months after enrollment in the study.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks
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
Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
16-item survey to measure genetic factual knowledge at baseline
Time Frame: 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
Effect size of associations of key predictors with genetic factual knowledge at baseline
Time Frame: 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
5 Likert scale survey questionnaire to measure importance of receiving genetic risk information
Time Frame: 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.
baseline
5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention uptake
Time Frame: 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.
baseline
5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention adherence
Time Frame: 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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Noha M Sharafeldin, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2017

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

March 17, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (Actual)

March 29, 2017

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X161221006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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