Clinical trial NCT04870320: Study of Attention and Memory Treatments for Cancer Survivors
Official title: A Pilot Study of A Novel Cognitive Intervention for Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Akili Interactive Labs, Inc.
First posted: 2021-05-03
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial investigates if certain electronic games may be effective in improving attention and memory function in cancer survivors. Cancer related cognitive impairment (CRCI) is an issue experienced by many cancer patients/survivors. CRCI includes perceived or objective problems with memory, executive function, and attention/concentration. CRCI has a negative impact on survivors' ability to work, carry out routine activities, and engage in social and family relationships. CRCI may result in significant distress and reduced quality of life. Certain electronic games may help improve attention and memory function in cancer survivors and reduce symptoms of CRCI.

Detailed description: PRIMARY OBJECTIVES:

I. Determine the recruitment and retention rates for both arms of this study. II. Determine the effect size for changes in cognitive function (i.e., Test of Variables of Attention (TOVA) \[i.e. attention\], Adaptive Cognitive Evaluation (ACE) \[i.e. working memory\]) in the intervention group compared to the control group following the 4-week study.

III. Evaluate adherence rates for and satisfaction with the interventions. IV. Evaluate for treatment-related adverse events (e.g., nausea, motion sickness).

SECONDARY OBJECTIVE:

I. To determine effect sizes for depression, fatigue, and sleep disturbance, by comparing changes in the intervention group to changes in the control group, following the 4-week study.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients play Endeavor over 25 minutes daily 5 days a week for 4 weeks.

ARM II: Patients play Words! over 25 minutes daily 5 days a week for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Attention Function Index (AFI) score of \< 7.5
* Are able to read, write, and understand English
* Ability to understand an electronic informed consent document, and the willingness to sign it
* Have a Karnofsky performance status (KPS) score of \>= 50
* Have access to WiFi connection

Exclusion Criteria:

* Receiving active treatment for cancer recurrence
* Have significant cognitive impairment
* Have sensory or motor deficits that prevent them from doing the assessment and using the application

Primary outcomes:
measure: Percentage of participants who completed the study
timeFrame: Up to 6 weeks
measure: Mean change in scores on the Test of Variables of Attention (TOVA) over time
timeFrame: Up to 4 weeks
measure: Percent change in scores on the TOVA over time
timeFrame: Up to 4 weeks
measure: Mean changes in Adaptive Cognitive Evaluation (ACE)
timeFrame: Up to 4 weeks
measure: Percent change in scores on the ACE over time
timeFrame: Up to 4 weeks
measure: Proportion of time using application
timeFrame: Up to 4 weeks
measure: Percentage of participants who experienced treatment-related adverse events
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Change in mean severity scores on the Center for Epidemiologic Studies - Depression Scale (CES-D)
timeFrame: Up to 4 weeks
measure: Change in mean severity scores on the Lee Fatigue Scale
timeFrame: Up to 4 weeks
measure: Change in severity scores on the General Sleep Disturbance Scale (GSDS)
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Christine Miaskowski, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: