Cognitive Enhancement Program in Improving Cognitive Function in Breast Cancer Survivors

Stanford University

Status: Withdrawn

Conditions: Breast Cancer; Cancer Survivor; Cognitive/Functional Effects

Treatments: Other: memory intervention; Other: cognitive intervention; Procedure: mind-body intervention procedure; Other: computer-assisted cognitive training; Other: questionnaire administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02166983

BRS0037 (Other Identifier)

NCI-2013-02353 (Registry Identifier)

P30CA124435 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This randomized clinical trial studies cognitive enhancement program in improving cognitive function in breast cancer survivors. A cognitive enhancement program may help improve cognitive function in breast cancer survivors and may help doctors plan better treatment for cognitive decline.

Full description

PRIMARY OBJECTIVES:

I. To improve cognition of women who have had breast cancer and exhibit cognitive decline through a cognitive enhancement program.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I (Cognitive Enhancement Program): Participants are randomized to 1 of 2 arms.

ARM IA (Lumosity): Participants complete Lumosity cognitive exercises. Lumosity cognitive exercises are online video game-based activities that are designed to practice various cognitive skills including processing speed, attention, memory and executive function. Participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. Participants also complete relaxation exercises (guided imagery, progressive muscle relaxation, and/or autogenics) at least 10 minutes a day for 6 weeks and compensatory strategies (the use of external devices such as a notebook, day planner, or smartphone for cuing, reminding, and organizing; the use of memory strategies such as repetition, paraphrasing, and active listening; and the use of executive strategies such as self-talk for planning and attention orientation) as much as possible.

ARM IB (Active Journaling): Participants complete Active Journal cognitive exercises. Active Journaling requires participants to keep a written diary or journal where she discusses what her thoughts and feelings about various events with a focus on describing the meaning of the activities and experiences, particularly new things that were learned. Active Journaling is a method of practicing various cognitive skills including communication, organization, memory and executive function. Participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. Participants also complete relaxation exercises and compensatory strategies as in Arm IA.

ARM II (Lumosity only): Participants complete Lumosity cognitive exercises as in Arm IA.

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previous diagnosis of breast cancer
• Received chemotherapy treatment for breast cancer diagnosis
• Chemotherapy-free for at least one year

Exclusion criteria

• History of learning disability, head trauma, neurologic disorder or significant psychiatric condition
• Significant medical condition (e.g. diabetes) unrelated to cancer diagnosis
• Magnetic resonance imaging (MRI) contraindications (e.g. metallic biomedical implants)
• Pregnancy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Arm IA (Lumosity, relaxation, compensatory strategies)

Experimental group

Description:

Participants complete Lumosity cognitive exercises. Lumosity cognitive exercises are online video game-based activities that are designed to practice various cognitive skills including processing speed, attention, memory and executive function. Participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. Participants also complete relaxation exercises (guided imagery, progressive muscle relaxation, and/or autogenics) at least 10 minutes a day for 6 weeks and compensatory strategies (the use of external devices such as a notebook, day planner, or smartphone for cuing, reminding, and organizing; the use of memory strategies such as repetition, paraphrasing, and active listening; and the use of executive strategies such as self-talk for planning and attention orientation) as much as possible.

Treatment:

Procedure: mind-body intervention procedure

Other: questionnaire administration

Other: computer-assisted cognitive training

Other: memory intervention

Arm IB (Active Journaling, relaxation, compensatory strategy)

Experimental group

Description:

Participants complete Active Journal cognitive exercises. Active Journaling requires participants to keep a written diary or journal where she discusses what her thoughts and feelings about various events with a focus on describing the meaning of the activities and experiences, particularly new things that were learned. Active Journaling is a method of practicing various cognitive skills including communication, organization, memory and executive function. Participants complete cognitive exercises at least 20 minutes a day, 5 days a week for 6 weeks. Participants also complete relaxation exercises and compensatory strategies as in Arm IA.

Treatment:

Procedure: mind-body intervention procedure

Other: cognitive intervention

Other: questionnaire administration

Other: memory intervention

Arm II (Lumosity only)

Experimental group

Description:

Participants complete Lumosity exercises as in Arm IA.

Treatment:

Other: questionnaire administration

Other: computer-assisted cognitive training