Study of Attention and Memory Treatments for Cancer Survivors

NCT04870320 | Completed DMC

• 2 other identifiers: 19803NCI-2021-02024
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Change in mean severity scores on the Center for Epidemiologic Studies - Depression Scale (CES-D)

  Up to 4 weeks

• Change in mean severity scores on the Lee Fatigue Scale

  Up to 4 weeks

• Change in severity scores on the General Sleep Disturbance Scale (GSDS)

  Up to 4 weeks

Study Arms (2)

Arm I (Endeavor)

EXPERIMENTAL

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

Behavioral: Endeavor: Computer-Based Cognitive Stimulation Intervention; Other: Quality of Life (QOL) Questionnaires

Arm II (Words!)

ACTIVE COMPARATOR

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

Behavioral: Words!: Computer-Based Cognitive Stimulation Intervention; Other: Quality of Life (QOL) Questionnaires

Interventions

Endeavor: Computer-Based Cognitive Stimulation Intervention BEHAVIORAL

Endeavor application will be utilized by participant on iPad

Also known as: Computer-Based Cognitive Stimulation Intervention, Computer-Based General Cognitive Stimulation Intervention

Arm I (Endeavor)

Words!: Computer-Based Cognitive Stimulation Intervention BEHAVIORAL

Words! application will be utilized by participant on iPad

Also known as: Computer-Based Cognitive Stimulation Intervention, Computer-Based General Cognitive Stimulation Intervention

Arm II (Words!)

Quality of Life (QOL) Questionnaires OTHER

Standardized QOL questionnaire will be administered at each study visit

Arm I (Endeavor); Arm II (Words!)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Akili Interactive Labs, Inc.: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Quality of Life; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Christine Miaskowski, RN, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: March 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)