Clinical trial NCT03094026: Cognitive Training Intervention and Attitudes Towards Genetics
Official title: Intervention Strategies to Improve Cognitive Functioning in Hematologic Cancer Survivors After Hematopoietic Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Hematologic Neoplasms
Hematopoietic Cell Transplant
Keywords: Hematologic cancers
Hematopoietic cell transplantation
cognitive training
genetic knowledge
genetic attitude
adult cancer survivors
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of HCT patients completing the 2-arm wait-listed randomized trial of cognitive training intervention for a period of 3 months
timeFrame: 12 weeks
measure: Change in cognitive function between intervention and wait list control arms from baseline to 12 weeks.
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: 16-item survey to measure genetic factual knowledge at baseline
timeFrame: Baseline
measure: Effect size of associations of key predictors with genetic factual knowledge at baseline
timeFrame: Baseline
measure: 5 Likert scale survey questionnaire to measure importance of receiving genetic risk information
timeFrame: baseline
measure: 5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention uptake
timeFrame: baseline
measure: 5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention adherence
timeFrame: baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Noha M Sharafeldin
role: PRINCIPAL_INVESTIGATOR
References: