Self-monitoring Activity: a Randomized Trial of Game-oriented Applications (SMARTGOAL)

• ClinicalTrials.gov Identifier: NCT02341235
• Recruitment Status: Completed
• First Posted: January 19, 2015
• Last Update Posted: August 9, 2021
• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborator: American Cancer Society, Inc.
• Information provided by (Responsible Party): The University of Texas Medical Branch, Galveston

Study Description

Brief Summary:

The purpose of this study is to compare an enhanced intervention that includes narrative and game components to a standard intervention that only targets self-monitoring. These approaches will be tested among postmenopausal breast cancer survivors who are sedentary and overweight.

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Obesity	Behavioral: Game intervention; Behavioral: Standard intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Self-monitoring Activity: a Randomized Trial of Game-oriented Applications (SMARTGOAL)
• Actual Study Start Date: February 2015
• Actual Primary Completion Date: June 30, 2020
• Actual Study Completion Date: June 30, 2021

Arms and Interventions

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)	Behavioral: Game intervention; 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)	Behavioral: Standard intervention; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in physical activity from baseline to 6 month [ Time Frame: 6 months ]
   Minutes of moderate-vigorous physical activity over a 7 day period

Secondary Outcome Measures :

1. 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
2. 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
3. Change in weight from baseline to 6 months [ Time Frame: 6 months ]
   We will measure weight using a calibrated scale
4. 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
5. 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. 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
7. 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
8. Change in sleep from baseline to 6 months, measured by a computerized PROMIS measure [ Time Frame: 6 months ]
   We will use a computerized PROMIS measure
9. Change in motivation from baseline to 6 months, measured by autonomous motivation specific to physical activity [ Time Frame: 6 months ]
   Behavioral Regulation in Exercise Questionnaire-2 will be used

Other Outcome Measures:

1. Maintenance of physical activity from 6 months to 1 year [ Time Frame: 6 months ]
   Minutes of moderate-vigorous physical activity measured over a 7 day period
2. Maintenance of physical fitness from 6 months to 1 year, measured by a 6 minute walk test [ Time Frame: 6 months ]
   We will use a 6 minute walk test to measure fitness
3. Maintenance of physical function from 6 months to 1 year, measured by the Senior Fitness Test [ Time Frame: 6 months ]
   We will use the Senior Fitness Test to measure physical function
4. Change in sleep from 6 months to 1 year, measured by a computerized PROMIS measure [ Time Frame: 6 months ]
   We will use a computerized PROMIS measure
5. Change in weight from 6 months to 1 year [ Time Frame: 6 months ]
   Weight will be measured using a calibrated scale
6. 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 ]
   We will use objective measures to investigate adherence to study protocols (game usage, monitor usage, phone calls completed, assessments attended, etc.)
7. Number of participants who report adverse events [ Time Frame: 1 year ]
   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.
8. Change in anxiety from 6 months to 1 year, measured by a computerized PROMIS measure [ Time Frame: 6 months ]
   We will use a computerized PROMIS measure
9. 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
10. 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
11. 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
12. Change in motivation from 6 months to 1 year, measured by autonomous motivation specific to physical activity [ Time Frame: 6 months ]
    Behavioral Regulation in Exercise Questionnaire-2 will be used
13. Acceptability, measured using self-report measures of usability and liking of the apps [ Time Frame: 6 months ]
    Participants will report their perceptions of app usability and acceptability in the 6 month questionnaire
14. Play experience, measured using the play experience questionnaire [ Time Frame: Measured at 3 months ]
    Participants will self-report their perceptions of the playfulness of the intervention apps
15. Change in exercise identity from baseline to 6 months, measured using the Exercise Identity Scale [ Time Frame: 6 months ]
    We will use the Exercise Identity Scale
16. Narrative engagement (measured in narrative group only), measured using the Narrative Engagement Scale [ Time Frame: Measured at 3 months ]
    We will measure the extent to which participants in the narrative group felt narratively engaged in the game's storyline
17. Character identification (measured in narrative group only), measured using the Player Identification Scale [ Time Frame: Measured at 3 months ]
    We will measure the extent to which participants in the narrative group felt like they identified with their game character

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Age between 45 and 75 years old
2. Report a breast cancer diagnosis no more than 10 years prior to enrollment
3. Cessation of menses for 12 months or more
4. Able to read and understand English
5. Able to read words in standard applications on a mobile device 3-4" large
6. Able to walk for exercise
7. Able to find transportation to the study location
8. Willing to use a mobile device provided by the study to participate (or to use one of their own)
9. Willing to be randomized to either group

Exclusion Criteria:

1. Currently pregnant or nursing
2. Surgery in the past six months
3. Chemotherapy or radiation treatment in the past six months
4. Evidence of disease recurrence
5. Participant is active (90 minutes of moderate-vigorous intensity activity per week or more)
6. BMI is under 25 kg/m2 or over 35 kg/m2
7. 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
8. Participant reports hospitalization within the past year due to psychiatric problem(s)
9. Report current symptoms of alcohol or substance dependence
10. Plans to move away from the Galveston-Houston area or to be out of town for more than 1 week during the study period
11. Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
12. Report a history of severe orthopedic complications that would prevent optimal participation in the physical activities prescribed (e.g., severe arthritis, leg amputations, etc.)
13. Clinical judgment concerning safety
14. Lost more than 5% body weight in the previous 6 months
15. Currently participating in a physical activity or weight loss program
16. Current smoker
17. Participant already uses an electronic activity monitor (we will ask them to stop)
18. Another member of the household is a participant or staff member on this trial

Contacts and Locations

Locations

United States, Texas

The University of Texas Medical Branch

Galveston, Texas, United States, 77550

Sponsors and Collaborators

The University of Texas Medical Branch, Galveston

American Cancer Society, Inc.

Investigators

• Principal Investigator: Elizabeth Lyons, PhD, MPH; University of Texas

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lyons EJ, Baranowski T, Basen-Engquist KM, Lewis ZH, Swartz MC, Jennings K, Volpi E. Testing the effects of narrative and play on physical activity among breast cancer survivors using mobile apps: study protocol for a randomized controlled trial. BMC Cancer. 2016 Mar 9;16:202. doi: 10.1186/s12885-016-2244-y.

• Responsible Party: The University of Texas Medical Branch, Galveston
• ClinicalTrials.gov Identifier: NCT02341235
• Other Study ID Numbers: 14-0376
• First Posted: January 19, 2015
• Last Update Posted: August 9, 2021
• Last Verified: August 2021

Keywords provided by The University of Texas Medical Branch, Galveston:

video game; narrative; story; survivorship; cancer survivor; mhealth; physical activity; women; women's health