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

Breast Cancer Clinical Trial

— SMARTGOAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02341235
• Other study ID #: 14-0376
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Medical Branch	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maintenance of physical activity from 6 months to 1 year	Minutes of moderate-vigorous physical activity measured over a 7 day period	6 months
Other	Maintenance of physical fitness from 6 months to 1 year, measured by a 6 minute walk test	We will use a 6 minute walk test to measure fitness	6 months
Other	Maintenance of physical function from 6 months to 1 year, measured by the Senior Fitness Test	We will use the Senior Fitness Test to measure physical function	6 months
Other	Change in sleep from 6 months to 1 year, measured by a computerized PROMIS measure	We will use a computerized PROMIS measure	6 months
Other	Change in weight from 6 months to 1 year	Weight will be measured using a calibrated scale	6 months
Other	Adherence, measured by objective measures to investigate adherence to study protocols (game usage, monitor usage, phone calls completed, assessments attended, etc.)	We will use objective measures to investigate adherence to study protocols (game usage, monitor usage, phone calls completed, assessments attended, etc.)	1 year
Other	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.	1 year
Other	Change in anxiety from 6 months to 1 year, measured by a computerized PROMIS measure	We will use a computerized PROMIS measure	6 months
Other	Change in depression from 6 months to 1 year, measured by a computerized PROMIS measure	We will use a computerized PROMIS measure specific to cancer patients/survivors	6 months
Other	Change in fatigue from baseline to 6 months, measured by a computerized PROMIS measure	We will use a computerized PROMIS measure specific to cancer patients/survivors	6 months
Other	Change in quality of life from 6 months to 1 year as measured by Functional Assessment of Cancer Therapy - Breast measure	We will use the Functional Assessment of Cancer Therapy - Breast measure	6 months
Other	Change in motivation from 6 months to 1 year, measured by autonomous motivation specific to physical activity	Behavioral Regulation in Exercise Questionnaire-2 will be used	6 months
Other	Acceptability, measured using self-report measures of usability and liking of the apps	Participants will report their perceptions of app usability and acceptability in the 6 month questionnaire	6 months
Other	Play experience, measured using the play experience questionnaire	Participants will self-report their perceptions of the playfulness of the intervention apps	Measured at 3 months
Other	Change in exercise identity from baseline to 6 months, measured using the Exercise Identity Scale	We will use the Exercise Identity Scale	6 months
Other	Narrative engagement (measured in narrative group only), measured using the Narrative Engagement Scale	We will measure the extent to which participants in the narrative group felt narratively engaged in the game's storyline	Measured at 3 months
Other	Character identification (measured in narrative group only), measured using the Player Identification Scale	We will measure the extent to which participants in the narrative group felt like they identified with their game character	Measured at 3 months
Primary	Change in physical activity from baseline to 6 month	Minutes of moderate-vigorous physical activity over a 7 day period	6 months
Secondary	Change in physical fitness from baseline to 6 months, as measured by 6 minute walk test	We will use a 6 minute walk test to measure fitness	6 months
Secondary	Change in physical function from baseline to 6 months as measured by the Senior Fitness Test	We will use the Senior Fitness Test to measure physical function	6 months
Secondary	Change in weight from baseline to 6 months	We will measure weight using a calibrated scale	6 months
Secondary	Change in quality of life from baseline to 6 months as measured by Functional Assessment of Cancer Therapy - Breast measure	We will use the Functional Assessment of Cancer Therapy - Breast measure	6 months
Secondary	Change in depression from baseline to 6 months, measured by a computerized PROMIS measure specific to cancer patients/survivors	We will use a computerized PROMIS measure specific to cancer patients/survivors	6 months
Secondary	Change in fatigue from baseline to 6 months, measured by a computerized PROMIS measure specific to cancer patients/survivors	We will use a computerized PROMIS measure specific to cancer patients/survivors	6 months
Secondary	Change in anxiety from baseline to 6 months, measured by a computerized PROMIS measure specific to cancer patients/survivors	We will use a computerized PROMIS measure specific to cancer patients/survivors	6 months
Secondary	Change in sleep from baseline to 6 months, measured by a computerized PROMIS measure	We will use a computerized PROMIS measure	6 months
Secondary	Change in motivation from baseline to 6 months, measured by autonomous motivation specific to physical activity	Behavioral Regulation in Exercise Questionnaire-2 will be used	6 months