Study of Attention and Memory Treatments for Cancer Survivors

University of California San Francisco (UCSF)

Status: Completed

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04870320

19803

NCI-2021-02024 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49 participants in 2 patient groups

Arm I (Endeavor)

Experimental group

Description:

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

Treatment:

Behavioral: Endeavor: Computer-Based Cognitive Stimulation Intervention

Other: Quality of Life (QOL) Questionnaires

Arm II (Words!)

Active Comparator group

Description:

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

Treatment:

Other: Quality of Life (QOL) Questionnaires

Behavioral: Words!: Computer-Based Cognitive Stimulation Intervention