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NCT Number: NCT03094026

Cognitive Training Intervention and Attitudes Towards Genetics

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.

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumosity

Behavioral

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

Lumosity (waitlist control)

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.

Primary outcomes

  1. 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

  2. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lindsey Hageman, MPH

CONTACT

[email protected]

2056382139

Noha M Sharafeldin, MD,MSc, PhD

CONTACT

[email protected]

2056382144

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Acronym: cTAG

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Mar 29, 2017
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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