Study of Attention and Memory Treatments for Cancer Survivors

NCT ID: NCT04870320

Last Updated: 2022-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm I (Endeavor)

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

Group Type EXPERIMENTAL

Endeavor: Computer-Based Cognitive Stimulation Intervention

Intervention Type BEHAVIORAL

Endeavor application will be utilized by participant on iPad

Quality of Life (QOL) Questionnaires

Intervention Type OTHER

Standardized QOL questionnaire will be administered at each study visit

Arm II (Words!)

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

Group Type ACTIVE_COMPARATOR

Words!: Computer-Based Cognitive Stimulation Intervention

Intervention Type BEHAVIORAL

Words! application will be utilized by participant on iPad

Quality of Life (QOL) Questionnaires

Intervention Type OTHER

Standardized QOL questionnaire will be administered at each study visit

Interventions

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Endeavor: Computer-Based Cognitive Stimulation Intervention

Endeavor application will be utilized by participant on iPad

Intervention Type BEHAVIORAL

Words!: Computer-Based Cognitive Stimulation Intervention

Words! application will be utilized by participant on iPad

Intervention Type BEHAVIORAL

Quality of Life (QOL) Questionnaires

Standardized QOL questionnaire will be administered at each study visit

Intervention Type OTHER

Other Intervention Names

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Computer-Based Cognitive Stimulation Intervention Computer-Based General Cognitive Stimulation Intervention Computer-Based Cognitive Stimulation Intervention Computer-Based General Cognitive Stimulation Intervention

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akili Interactive Labs, Inc.

INDUSTRY

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Miaskowski, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2021-02024

Identifier Type: REGISTRY

Identifier Source: secondary_id

19803

Identifier Type: -

Identifier Source: org_study_id

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