Cognitive Training Intervention and Attitudes Towards Genetics

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cognitive Impairment, Hematologic Neoplasms, Hematopoietic Cell Transplant

Intervention / Treatment
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* Behavioral: Lumosity
* Behavioral: Lumosity (waitlist control)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematologic cancers, Hematopoietic cell transplantation, cognitive training, genetic knowledge, genetic attitude, adult cancer survivors