NCT03094026

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Aug 2017Jul 2027

First Submitted

Initial submission to the registry

March 17, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

August 21, 2017

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

9.9 years

First QC Date

March 17, 2017

Last Update Submit

April 16, 2026

Conditions

Cognitive ImpairmentHematologic NeoplasmsHematopoietic Cell Transplant

Keywords

Hematologic cancersHematopoietic cell transplantationcognitive traininggenetic knowledgegenetic attitudeadult cancer survivors

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 16-item survey to measure genetic factual knowledge at baseline

    Baseline

  • Effect size of associations of key predictors with genetic factual knowledge at baseline

    Baseline

  • 5 Likert scale survey questionnaire to measure importance of receiving genetic risk information

    baseline

  • 5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention uptake

    baseline

  • 5 Likert scale survey questionnaire to measure impact of receiving genetic risk information on intervention adherence

    baseline

Study Arms (2)

Intervention

EXPERIMENTAL

The arm will begin the Lumosity program at enrollment in the study.

Behavioral: Lumosity

Wait List Control

ACTIVE COMPARATOR

The arm will begin the Lumosity program 3 months after enrollment in the study.

Behavioral: Lumosity (waitlist control)

Interventions

LumosityBEHAVIORAL

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

Intervention
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.

Wait List Control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionHematologic Neoplasms

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Noha M Sharafeldin

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noha M Sharafeldin, MD,MSc, PhD

CONTACT

2056382144nsharaf@uab.edu

Lindsey Hageman, MPH

CONTACT

2056382139lhageman@peds.uab.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

March 17, 2017

First Posted

March 29, 2017

Study Start

August 21, 2017

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Locations

US(1)