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

Not Applicable

Completed

• Conditions: Obesity; Breast Cancer
• Interventions: Behavioral: Game intervention; Behavioral: Standard intervention

• Registration Number: NCT02341235
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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.

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 Timeline

• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-19
• Study Start: 2015-02
• Primary Completion: 2020-06-30
• Study Completion: 2021-06-30
• Results First Submitted: 2022-06-17
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Results First Posted: 2024-07-31
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Game intervention	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)
Standard intervention	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)

Primary Outcome Measures

Name	Time	Method
Change in Minutes Per Day of Physical Activity	baseline and 6 months	Minutes of moderate-vigorous physical activity per day (averaged over a 7 day period) at baseline and 6 months.

Secondary Outcome Measures

Name	Time	Method
Change in Intrinsic Motivation From Baseline to 6 Months, Measured by Intrinsic Motivation Specific to Physical Activity	baseline to 6 months	The Behavioral Regulation in Exercise Questionnaire-2 intrinsic regulation subscale will be used. This subscale includes 4 items measured using a 5 point scale (not true for me to very true for me), with a range of scores from 0-12. A higher number indicates higher intrinsic motivation.
Change in Identified Regulation From Baseline to 6 Months, Measured by Identified Regulation Specific to Physical Activity	baseline to 6 Months	The Behavioral Regulation in Exercise Questionnaire-2 identified regulation subscale will be used. This subscale includes 4 items measured using a 5 point scale (not true for me to very true for me), with a range of scores from 0-12. A higher number indicates a greater amount of identified regulation.
Change in Integrated Regulation From Baseline to 6 Months, Measured by Integrated Regulation Specific to Physical Activity	baseline to 6 Months	We will use items from P.M. Wilson and colleague's expansion of the Behavioral Regulation in Exercise Questionnaire-2 to include integrated regulation. This subscale includes 4 items measured using a 5 point scale (not true for me to very true for me), with a range of scores from 0-12. A higher number indicates a greater amount of identified regulation.
Change in Weight From Baseline to 6 Months	baseline to 6 months	We will measure weight using a calibrated scale
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Arm Curl Measure	baseline to 6 Months	We will use the Senior Fitness Test to measure physical function, specifically in regards to the number of arm curls that can be completed within 30 seconds. A higher number indicates better function in this area.
Change in Physical Fitness From Baseline to 6 Months, as Measured by 6 Minute Walk Test	baseline to 6 months	We will use a 6 minute walk test to measure fitness, measured in feet walked in six minutes on a pre-marked indoor course
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Chair Stand Measure	baseline to 6 months	We will use the Senior Fitness Test to measure physical function, specifically in regards to the number of chair stands that can be completed within 30 seconds. A higher number indicates better function in this area.
Change in Social/Family Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Social/Family Well-Being Subscale	baseline to 6 months	We will use the Functional Assessment of Cancer Therapy - Breast measure's social/family subscale. This scale has a range of 0-28 and 7 items measured on a 5-point scale (not at all to very much). A higher score indicates greater social/family quality of life.
Change in Functional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Functional Well-Being Subscale	baseline to 6 Months	We will use the Functional Assessment of Cancer Therapy - Breast measure's functional subscale. This scale has a range of 0-28 and 7 items measured on a 5-point scale (not at all to very much). A higher score indicates greater functional quality of life
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Back Scratch Measure	baseline to 6 Months	We will use the Senior Fitness Test to measure physical function, specifically in regards to the distance between an individual's arms when they reach them behind their back (one higher above the shoulder and one lower). A higher number indicates better function in this area.
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's 8 Foot Up and Go Test	baseline to 6 Months	We will use the Senior Fitness Test to measure physical function, specifically in regards to the time in which an individual can sit up, walk 8 feet around a cone, and sit back down. A lower number indicates better function in this area.
Change in Emotional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Emotional Well-Being Subscale	baseline to 6 Months	We will use the Functional Assessment of Cancer Therapy - Breast measure's emotional subscale. This scale has a range of 0-24 and 6 items measured on a 5-point scale (not at all to very much). A higher score indicates greater emotional quality of life
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Sit and Reach Measure	baseline to 6 Months	We will use the Senior Fitness Test to measure physical function, specifically in regards to the distance an individual can reach from their toes when bending forward. A higher number indicates better function in this area.
Change in Physical Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure	baseline to 6 months	We will use the Functional Assessment of Cancer Therapy - Breast measure's physical subscale. This scale has a range of 0-28 and 7 items measured on a 5 point scale (not at all to very much). A higher score indicates greater physical quality of life.
Change in Breast Cancer-Specific Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Breast Cancer Subscale	baseline to 6 Months	We will use the Functional Assessment of Cancer Therapy - Breast measure's breast cancer subscale. This scale has a range of 0-40 and 10 items measured on a 5-point scale (not at all to very much). A higher score indicates greater breast cancer-related quality of life

Trial Locations

Locations (1)

The University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States