- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02341235
Self-monitoring Activity: a Randomized Trial of Game-oriented Applications (SMARTGOAL)
Self-monitoring Activity: a Randomized Trial of Game-oriented Applications (SMARTGOAL)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Habitual physical activity decreases risk of multiple negative health outcomes, including breast cancer recurrence and mortality. It is also associated with better quality of life and reducing negative effects of cancer and cancer treatment. However, most breast cancer survivors do not engage in sufficient physical activity. Behavior change interventions produce short-term increases in activity but have difficulty motivating sustained active lifestyles over longer periods and are not equally effective in women of different races/ethnicities. The purpose of this study is to test a novel intervention that uses video games and storytelling to increase motivation. Video game mechanics increase enjoyment and feelings of autonomy (control), competence, and relatedness to others. All of these feelings are associated with motivation for activity and, in turn, sustained activity over time. Additionally, narrative storytelling is an effective method of persuading individuals to change their behavior. We propose that play of active video games that include compelling storylines will increase physical activity among a diverse sample of postmenopausal breast cancer survivors.
To test this hypothesis, we will conduct a clinical trial that compares the enhanced intervention (story-based video games) to a standard intervention in 90 sedentary, overweight postmenopausal breast cancer survivors. Participants in the enhanced group will receive a mobile device and accessories with two story-based video game applications installed. The games incorporate behavior change strategies such as self-monitoring and feedback while also using game mechanics and a lengthy storyline to motivate physical activity. Participants in the standard group will receive the same mobile device with an electronic activity monitor and its companion feedback application. Both groups will receive brief weekly telephone counseling. By comparing two groups that both receive typical behavior change intervention components (counseling) and a novel electronic intervention, we will be able to investigate the specific effects of game mechanics and storytelling on motivation and physical activity. We will measure changes in physical activity, fitness, function, and quality of life from the beginning of the study to 6 months. We will also investigate further changes during an additional 6 month follow-up period in which participants keep their intervention tools but do not receive any counseling, to measure maintenance of activity. This project will develop and test a promising, innovative intervention that has the potential to be used on a widespread basis in clinical and community settings.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Texas
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Galveston, Texas, United States, 77550
- The University of Texas Medical Branch
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 45 and 75 years old
- Report a breast cancer diagnosis no more than 10 years prior to enrollment
- Cessation of menses for 12 months or more
- Able to read and understand English
- Able to read words in standard applications on a mobile device 3-4" large
- Able to walk for exercise
- Able to find transportation to the study location
- Willing to use a mobile device provided by the study to participate (or to use one of their own)
- Willing to be randomized to either group
Exclusion Criteria:
- Currently pregnant or nursing
- Surgery in the past six months
- Chemotherapy or radiation treatment in the past six months
- Evidence of disease recurrence
- Participant is active (90 minutes of moderate-vigorous intensity activity per week or more)
- BMI is under 25 kg/m2 or over 35 kg/m2
- 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
- Participant reports hospitalization within the past year due to psychiatric problem(s)
- 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
- Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
- Report a history of severe orthopedic complications that would prevent optimal participation in the physical activities prescribed (e.g., severe arthritis, leg amputations, etc.)
- Clinical judgment concerning safety
- Lost more than 5% body weight in the previous 6 months
- Currently participating in a physical activity or weight loss program
- Current smoker
- Participant already uses an electronic activity monitor (we will ask them to stop)
- Another member of the household is a participant or staff member on this trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Game intervention
Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)
|
The game will target motivation via narrative and game mechanics.
It will also encourage self-regulation by providing monitoring and feedback of activity.
Counseling will be adapted to specifically reference concepts related to narrative and games.
|
Active Comparator: Standard intervention
Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)
|
The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals.
Counseling will be standard and concentrate on self-regulatory skill-building.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in physical activity from baseline to 6 month
Time Frame: 6 months
|
Minutes of moderate-vigorous physical activity over a 7 day period
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in physical fitness from baseline to 6 months, as measured by 6 minute walk test
Time Frame: 6 months
|
We will use a 6 minute walk test to measure fitness
|
6 months
|
Change in physical function from baseline to 6 months as measured by the Senior Fitness Test
Time Frame: 6 months
|
We will use the Senior Fitness Test to measure physical function
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6 months
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Change in weight from baseline to 6 months
Time Frame: 6 months
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We will measure weight using a calibrated scale
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6 months
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Change in quality of life from baseline to 6 months as measured by Functional Assessment of Cancer Therapy - Breast measure
Time Frame: 6 months
|
We will use the Functional Assessment of Cancer Therapy - Breast measure
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6 months
|
Change in depression from baseline to 6 months, measured by a computerized PROMIS measure specific to cancer patients/survivors
Time Frame: 6 months
|
We will use a computerized PROMIS measure specific to cancer patients/survivors
|
6 months
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Change in fatigue from baseline to 6 months, measured by a computerized PROMIS measure specific to cancer patients/survivors
Time Frame: 6 months
|
We will use a computerized PROMIS measure specific to cancer patients/survivors
|
6 months
|
Change in anxiety from baseline to 6 months, measured by a computerized PROMIS measure specific to cancer patients/survivors
Time Frame: 6 months
|
We will use a computerized PROMIS measure specific to cancer patients/survivors
|
6 months
|
Change in sleep from baseline to 6 months, measured by a computerized PROMIS measure
Time Frame: 6 months
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We will use a computerized PROMIS measure
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6 months
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Change in motivation from baseline to 6 months, measured by autonomous motivation specific to physical activity
Time Frame: 6 months
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Behavioral Regulation in Exercise Questionnaire-2 will be used
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6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maintenance of physical activity from 6 months to 1 year
Time Frame: 6 months
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Minutes of moderate-vigorous physical activity measured over a 7 day period
|
6 months
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Maintenance of physical fitness from 6 months to 1 year, measured by a 6 minute walk test
Time Frame: 6 months
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We will use a 6 minute walk test to measure fitness
|
6 months
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Maintenance of physical function from 6 months to 1 year, measured by the Senior Fitness Test
Time Frame: 6 months
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We will use the Senior Fitness Test to measure physical function
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6 months
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Change in sleep from 6 months to 1 year, measured by a computerized PROMIS measure
Time Frame: 6 months
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We will use a computerized PROMIS measure
|
6 months
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Change in weight from 6 months to 1 year
Time Frame: 6 months
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Weight will be measured using a calibrated scale
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6 months
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Adherence, measured by objective measures to investigate adherence to study protocols (game usage, monitor usage, phone calls completed, assessments attended, etc.)
Time Frame: 1 year
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We will use objective measures to investigate adherence to study protocols (game usage, monitor usage, phone calls completed, assessments attended, etc.)
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1 year
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Number of participants who report adverse events
Time Frame: 1 year
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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.
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1 year
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Change in anxiety from 6 months to 1 year, measured by a computerized PROMIS measure
Time Frame: 6 months
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We will use a computerized PROMIS measure
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6 months
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Change in depression from 6 months to 1 year, measured by a computerized PROMIS measure
Time Frame: 6 months
|
We will use a computerized PROMIS measure specific to cancer patients/survivors
|
6 months
|
Change in fatigue from baseline to 6 months, measured by a computerized PROMIS measure
Time Frame: 6 months
|
We will use a computerized PROMIS measure specific to cancer patients/survivors
|
6 months
|
Change in quality of life from 6 months to 1 year as measured by Functional Assessment of Cancer Therapy - Breast measure
Time Frame: 6 months
|
We will use the Functional Assessment of Cancer Therapy - Breast measure
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6 months
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Change in motivation from 6 months to 1 year, measured by autonomous motivation specific to physical activity
Time Frame: 6 months
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Behavioral Regulation in Exercise Questionnaire-2 will be used
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6 months
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Acceptability, measured using self-report measures of usability and liking of the apps
Time Frame: 6 months
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Participants will report their perceptions of app usability and acceptability in the 6 month questionnaire
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6 months
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Play experience, measured using the play experience questionnaire
Time Frame: Measured at 3 months
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Participants will self-report their perceptions of the playfulness of the intervention apps
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Measured at 3 months
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Change in exercise identity from baseline to 6 months, measured using the Exercise Identity Scale
Time Frame: 6 months
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We will use the Exercise Identity Scale
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6 months
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Narrative engagement (measured in narrative group only), measured using the Narrative Engagement Scale
Time Frame: Measured at 3 months
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We will measure the extent to which participants in the narrative group felt narratively engaged in the game's storyline
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Measured at 3 months
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Character identification (measured in narrative group only), measured using the Player Identification Scale
Time Frame: Measured at 3 months
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We will measure the extent to which participants in the narrative group felt like they identified with their game character
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Measured at 3 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Elizabeth Lyons, PhD, MPH, University of Texas
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14-0376
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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