Cognitive ImpairmentcTAGNCT03094026
Cognitive Training Intervention and Attitudes Towards Genetics
A study testing Lumosity in people with Cognitive Impairment and Hematologic Neoplasms, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cognitive Impairment, Hematologic Neoplasms, Hematopoietic Cell Transplant
- What is being tested?
- Lumosity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2017to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Noha Sharafeldin, MD, MSc, PhD, 2056382144, nsharaf@uab.edu
Lindsey Hageman, MPH, CCRP, 2056382139, lhageman@peds.uab.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- Lumosity, Lumosity (waitlist control)
- Keywords
- Hematologic cancers, Hematopoietic cell transplantation, cognitive training, genetic knowledge, genetic attitude, adult cancer survivors
- Medical subject headings
- Cognitive Dysfunction, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumosityBehavioural
Computer-based online cognitive training program using the Lumosity cognitive training program.
Lumosity (waitlist control)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The arm will begin the Lumosity program at enrollment in the study. Receives: Behavioral: Lumosity |
| Wait List Control | Active comparator | The arm will begin the Lumosity program 3 months after enrollment in the study. Receives: Behavioral: Lumosity (waitlist control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
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
Measured: Baseline to 12 weeks
Secondary outcomes (5)
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start21 Aug 2017
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mohamed Sharafeldin, University of Alabama at Birmingham
- Investigators
- Noha M Sharafeldin, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094026
- Sponsor's protocol ID
- X161221006
- Acronym
- cTAG
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2017
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Strategies to Improve Cognitive Functioning in Hematologic Cancer Survivors After Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT03094026
- Acronym / sponsor ID
- cTAG / X161221006
- Keywords
- Hematologic cancers, Hematopoietic cell transplantation, cognitive training, genetic knowledge, genetic attitude, adult cancer survivors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: LumosityThe arm will begin the Lumosity program at enrollment in the study. |
| Wait List Control | Active comparator | Behavioral: Lumosity (waitlist control)The arm will begin the Lumosity program 3 months after enrollment in the study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LumosityComputer-based online cognitive training program using the Lumosity cognitive training program. | Behavioural | Intervention |
| 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. | Behavioural | Wait List Control |
Primary outcome
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
5 secondary outcomes
16-item survey to measure genetic factual knowledge at baseline
Time frame: Baseline
Effect size of associations of key predictors with genetic factual knowledge at baseline
Time frame: Baseline
5 Likert scale survey questionnaire to measure importance of receiving genetic risk information
Time frame: baseline
5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention uptake
Time frame: baseline
5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention adherence
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noha M Sharafeldin principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumosity in people with Cognitive Impairment and Hematologic Neoplasms, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha M Sharafeldin, MD,MSc, PhD (2056382144, nsharaf@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.