Cognitive Training Intervention and Attitudes Towards Genetics (cTAG)
Primary Purpose
Cognitive Impairment, Hematologic Neoplasms, Hematopoietic Cell Transplant
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumosity
Lumosity (waitlist control)
Sponsored by
About this trial
This is an interventional supportive care trial for Cognitive Impairment focused on measuring Hematologic cancers, Hematopoietic cell transplantation, cognitive training, genetic knowledge, genetic attitude, adult cancer survivors
Eligibility Criteria
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
Sites / Locations
- University of Alabama at BirminghamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Wait List Control
Arm Description
The arm will begin the Lumosity program at enrollment in the study.
The arm will begin the Lumosity program 3 months after enrollment in the study.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03094026
First Posted
March 17, 2017
Last Updated
April 18, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT03094026
Brief Title
Cognitive Training Intervention and Attitudes Towards Genetics
Acronym
cTAG
Official Title
Intervention Strategies to Improve Cognitive Functioning in Hematologic Cancer Survivors After Hematopoietic Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2017 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Hematologic Neoplasms, Hematopoietic Cell Transplant
Keywords
Hematologic cancers, Hematopoietic cell transplantation, cognitive training, genetic knowledge, genetic attitude, adult cancer survivors
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The arm will begin the Lumosity program at enrollment in the study.
Arm Title
Wait List Control
Arm Type
Active Comparator
Arm Description
The arm will begin the Lumosity program 3 months after enrollment in the study.
Intervention Type
Behavioral
Intervention Name(s)
Lumosity
Intervention Description
Computer-based online cognitive training program using the Lumosity cognitive training program.
Intervention Type
Behavioral
Intervention Name(s)
Lumosity (waitlist control)
Intervention Description
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 Outcome Measure Information:
Title
Number of HCT patients completing the 2-arm wait-listed randomized trial of cognitive training intervention for a period of 3 months
Description
Number of participants completing the 12 week intervention
Time Frame
12 weeks
Title
Change in cognitive function between intervention and wait list control arms from baseline to 12 weeks.
Description
Change in cognitive function will be measured using cognitive test scores at baseline and 12 weeks
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
16-item survey to measure genetic factual knowledge at baseline
Description
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.
Time Frame
Baseline
Title
Effect size of associations of key predictors with genetic factual knowledge at baseline
Description
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.
Time Frame
Baseline
Title
5 Likert scale survey questionnaire to measure importance of receiving genetic risk information
Description
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.
Time Frame
baseline
Title
5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention uptake
Description
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.
Time Frame
baseline
Title
5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention adherence
Description
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.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noha M Sharafeldin, MD,MSc, PhD
Phone
2056382144
Email
nsharaf@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsey Hageman, MPH
Phone
2056382139
Email
lhageman@peds.uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noha M Sharafeldin
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noha Sharafeldin, MD, MSc, PhD
Phone
205-638-2144
Email
nsharaf@uab.edu
First Name & Middle Initial & Last Name & Degree
Lindsey Hageman, MPH, CCRP
Phone
2056382139
Email
lhageman@peds.uab.edu
12. IPD Sharing Statement
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Cognitive Training Intervention and Attitudes Towards Genetics
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