Study of Attention and Memory Treatments for Cancer Survivors

Malignant Solid Neoplasm Clinical Trial

Official title:

A Pilot Study of A Novel Cognitive Intervention for Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04870320
• Other study ID #: 19803
• Secondary ID: NCI-2021-02024
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: March 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Behavioral:
• Endeavor: Computer-Based Cognitive Stimulation Intervention
Endeavor application will be utilized by participant on iPad
• Words!: Computer-Based Cognitive Stimulation Intervention
Words! application will be utilized by participant on iPad

Other:
• Quality of Life (QOL) Questionnaires
Standardized QOL questionnaire will be administered at each study visit

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Akili Interactive Labs, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who completed the study	Completion is defined as participants who completed all 4 weeks of intervention and final assessment.	Up to 6 weeks
Primary	Mean change in scores on the Test of Variables of Attention (TOVA) over time	The TOVA records responses to visual or auditory stimuli through the participants iPAD, with a unique, highly accurate +/1 millisecond (ms) microswitch. The TOVA (Copyright 1991- 2021 by The TOVA Company) automatically calculates response time variability (consistency), response time (speed), commissions (impulsivity), and omissions (focus and vigilance). Results are reported as standard scores (average = 100 with a standard deviation of 15) and are compared to a large normative sample stratified by gender and age. Scores above 85 are within normal limits, 80-85 are borderline, and below 80 are not within normal limits. The mean change in scores will be estimated as the norm-based standardized difference in means from enrollment (Week 1) to the last assessment (Week 4).	Up to 4 weeks
Primary	Percent change in scores on the TOVA over time	The TOVA records responses to visual or auditory stimuli through the participants iPAD, with a unique, highly accurate +/1 millisecond (ms) microswitch. The TOVA (Copyright 1991- 2021 by The TOVA Company) automatically calculates response time variability (consistency), response time (speed), commissions (impulsivity), and omissions (focus and vigilance). Results are reported as standard scores (average = 100 with a standard deviation of 15) and are compared to a large normative sample stratified by gender and age. Scores above 85 are within normal limits, 80-85 are borderline, and below 80 are not within normal limits. Will be estimated as the standardized difference between the groups in the percent score change from enrollment (Week 1) to the last assessment (Week 4).	Up to 4 weeks
Primary	Mean changes in Adaptive Cognitive Evaluation (ACE)	The ACE is a mobile cognitive control assessment battery containing standard tests that assess different aspects of cognitive control (attention, working memory, and goal management), modified by incorporating adaptive algorithms, immersive graphics, video tutorials, motivating feedback, and a user-friendly interface. The ACE is administered to all participants via iPad and the scores will be estimated as the standardized difference in means from enrollment (Week 1) to the last assessment (Week 4).	Up to 4 weeks
Primary	Percent change in scores on the ACE over time	The ACE is a mobile cognitive control assessment battery containing standard tests that assess different aspects of cognitive control (attention, working memory, and goal management), modified by incorporating adaptive algorithms, immersive graphics, video tutorials, motivating feedback, and a user-friendly interface. The ACE is administered to all participants via iPad and the scores will be estimated as the standardized difference between the groups in the percent score change from enrollment (Week 1) to the last assessment (Week 4).	Up to 4 weeks
Primary	Proportion of time using application	Adherence rate will be evaluated by comparing the amount of time the participant should have used the application to the actual amount of time the participant used the application.	Up to 4 weeks
Primary	Percentage of participants who experienced treatment-related adverse events	Safety analyses will involve examination of and comparison between groups for the percentage of participants by adverse event severity and type of treatment-related adverse events. Comparisons of the frequencies between groups will be conducted using Chi-square or Fisher's exact test.	Up to 6 weeks
Secondary	Change in mean severity scores on the Center for Epidemiologic Studies - Depression Scale (CES-D)	The CES-D scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week. Responses are rated on a 5 point Likert scale with response option ranging 0="Rarely or none of the time (less than 1 day )" to 4='Most or all of the time (5-7 days)". The scoring of positive items is reversed. Possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology and will be estimated as the standardized difference in means of each measure at the last assessment from enrollment to the last assessment.	Up to 4 weeks
Secondary	Change in mean severity scores on the Lee Fatigue Scale	The Lee Fatigue Scale is used to measure the impact of fatigue on a participants quality of life. The scale consists of 18 items relating to the subjective experience of fatigue. Each item is rated on a 0 to 10 numeric rating scale (e.g., from "not at all tired" to "extremely tired"). Scores can range from 0 to 10. The instrument has two subscales: fatigue (items 1-5 and 11-18) and energy (items 6-10). The fatigue subscale score is calculated as the mean of the 13 fatigue items and the energy subscale score is the mean of the 5 energy items. Higher scores on the fatigue subscale represent greater fatigue severity, and higher scores on the energy subscale indicate higher levels of energy and will be estimated as the standardized difference in means of each measure at the last assessment from enrollment to the last assessment.	Up to 4 weeks
Secondary	Change in severity scores on the General Sleep Disturbance Scale (GSDS)	The GSDS consists of 21 items related to frequency in the past month of difficulty getting to sleep when respondents were asked to think about the past month, and each response is on a 8-point Likert scale from 0 ("never") to 7 ("all the time"). Will be estimated as the standardized difference in means of each measure at the last assessment, and as the difference between the groups in the percent change from enrollment to the last assessment.	Up to 4 weeks