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| ID | Type | Description | Link |
|---|---|---|---|
| 1K07CA175141-01A1 | U.S. NIH Grant/Contract | View source |
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Relinquished grant funding due to receipt of another incompatible grant
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity intervention | Behavioral | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who drop out of the study from baseline to 6 weeks | We will investigate the number of participants who drop out of the intervention group in comparison to similar studies | 6 weeks |
| Acceptability |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth J Lyons, PhD, MPH | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009765 | Obesity |
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
| 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 |
We will measure acceptability of the intervention components and tools using validated self-report measures and qualitative interviews/focus groups
| 6 weeks |
| Number of participants who report adverse events | We will inquire about potential adverse events during counseling calls and assessment visits. Discrete events will be summed, and the number of participants with events will be summed. | 6 weeks |
| Adherence | We will use objective measures to investigate adherence to game play protocols (console logs, automatic postings to the console social network, etc.) | 6 weeks |
| D050177 |
| Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |