LEVEL UP: Video Games for Activity in Breast Cancer Survivors

Study Overview
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Brief Summary
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The purpose of this study is to test an intervention that uses home console video games to encourage increased physical activity among postmenopausal breast cancer survivors.

Detailed Description
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This research project includes qualitative and quantitative formative research leading to a randomized controlled feasibility trial of a video game-based physical activity intervention. First, we will investigate exercise protocols implemented over 6 weeks in 20 breast cancer survivors. We will choose a console and six games for inclusion in the trial, based on measured energy expenditure and enjoyment. We will create refined exercise protocols using these games and insights from participants. Second, we will test an intervention that uses active video games for implementation of motivating exercise and provision of behavioral tools (e.g., tracking of progress towards goals). Participants in a pre-pilot trial (N = 10) will receive weekly brief telephone counseling over 6 weeks. Feasibility measurement will include attrition, self-reported acceptability, and objective measures of video game play taken from game console data.

Official Title
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LEVEL UP: Leveraging Electronic Videogames for Exercise and Leisure: Understanding Preferences of Breast Cancer Survivors

Conditions
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Breast Cancer, Obesity

Intervention / Treatment
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* Behavioral: Physical activity intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Aged 45 - 75 Diagnosed with breast cancer within the past 10 years Exclusion Criteria: Chemotherapy or radiation treatment in the past six months Surgery in the past six months Evidence of disease recurrence Unable to read and understand English Unable to see a TV screen from several feet away Unable to find transportation to the study location No Internet access in the home (only for intervention portion of the study) Participant is active (60 minutes of moderate-vigorous intensity activity per week or more) BMI is under 18.5 kg/m2 or over 40 kg/m2 Participant reports psychological issues that would interfere with study completion. Examples will be provided to illustrate potential psychological issues, such as dementia or schizophrenia. Inadequate performance on Senior Fitness Test, indicating inability to engage in video game exercise procedures (total score < 9 out of 12) Report a heart condition, chest pain during periods of activity or rest, loss of consciousness, etc. on the Physical Activity Readiness Questionnaire (PAR-Q), unless cleared by their physician Unable to walk, jump, and jog as may be required by some games (self-report) Report current symptoms of alcohol or substance dependence Plans to move away from the Galveston-Houston area or to be out of town for more than 1 week during the study period Unwillingness to report drugs taken for comorbidities such as hypertension or diabetes Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months Report a history of orthopedic complications that would prevent optimal participation in the physical activities prescribed (e.g., heel spurs, severe arthritis) Clinical judgment concerning safety Currently participating in a physical activity or weight program/research study Currently pregnant or nursing No TV is available in the participant's home Currently on a weight loss diet or has lost more than 5% body weight in the previous 6 months Current smoker Game console to be used in the study is already available in the home Another member of the household is a participant or staff member on this trial

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity intervention<br>This arm will receive the physical activity intervention, which consists of three individual meetings, weekly brief counseling phone calls for 6 weeks, and provision of a video game console with three active video games. | Behavioral: Physical activity intervention<br>* Participants will receive counseling on self-regulatory skill building that has been adapted to complement the video games used. We anticipate that the games used will consist of fitness, sports, and dance games and will be played on a Wii U console. The games played will be chosen by each participant from a pool of potential appropriate games.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity from baseline to 6 weeks | Minutes of moderate-vigorous physical activity measured over a 7 day period | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical fitness from baseline to 6 weeks | We will use a six minute walk test to measure fitness | 6 weeks | 
| Change in weight from baseline to 6 weeks | Weight will be measured using a calibrated scale | 6 weeks | 
| Change in motivation from baseline to 6 weeks | We will measure autonomous motivation (intrinsic, integrated, identified, etc.) specific to physical activity | 6 weeks | 
| Change in body function from baseline to 6 weeks | We will use the Senior Fitness Test to measure strength and body function | 6 weeks | 
| Change in quality of life from baseline to 6 weeks | We will use the Functional Assessment of Cancer Therapy - Breast measure to quantify quality of life | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, video game, women, women's health, breast cancer, cancer, survivorship, cancer survivor