Clinical trial NCT02341235: Self-monitoring Activity: a Randomized Trial of Game-oriented Applications
Official title: Self-monitoring Activity: a Randomized Trial of Game-oriented Applications (SMARTGOAL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Obesity
Keywords: video game
narrative
story
survivorship
cancer survivor
mhealth
physical activity
women
women's health
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2015-01-19
Enrollment: 90
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change in Minutes Per Day of Physical Activity
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Change in Physical Fitness From Baseline to 6 Months, as Measured by 6 Minute Walk Test
timeFrame: baseline to 6 months
measure: Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Chair Stand Measure
timeFrame: baseline to 6 months
measure: Change in Weight From Baseline to 6 Months
timeFrame: baseline to 6 months
measure: Change in Physical Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure
timeFrame: baseline to 6 months
measure: Change in Intrinsic Motivation From Baseline to 6 Months, Measured by Intrinsic Motivation Specific to Physical Activity
timeFrame: baseline to 6 months
measure: 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
timeFrame: baseline to 6 months
measure: 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
timeFrame: baseline to 6 Months
measure: 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
timeFrame: baseline to 6 Months
measure: 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
timeFrame: baseline to 6 Months
measure: Change in Identified Regulation From Baseline to 6 Months, Measured by Identified Regulation Specific to Physical Activity
timeFrame: baseline to 6 Months
measure: Change in Integrated Regulation From Baseline to 6 Months, Measured by Integrated Regulation Specific to Physical Activity
timeFrame: baseline to 6 Months
measure: Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Arm Curl Measure
timeFrame: baseline to 6 Months
measure: Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Sit and Reach Measure
timeFrame: baseline to 6 Months
measure: Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Back Scratch Measure
timeFrame: baseline to 6 Months
measure: Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's 8 Foot Up and Go Test
timeFrame: baseline to 6 Months
Other outcomes:
measure: Maintenance of Physical Fitness From 6 Months to 1 Year, Measured by a 6 Minute Walk Test
timeFrame: baseline to 6 months
measure: Maintenance of Physical Function From 6 Months to 1 Year, Measured by the Senior Fitness Test
timeFrame: baseline to 6 months
measure: Change in Sleep From 6 Months to 1 Year
timeFrame: baseline to 6 months
measure: Change in Weight From 6 Months to 1 Year
timeFrame: baseline to 6 months
measure: Adherence, Measured by Objective Measures to Investigate Adherence to Study Protocols
timeFrame: 1 year
measure: Number of Participants Who Report Adverse Events
timeFrame: 1 year
measure: Change in Anxiety From Baseline to 6 Months
timeFrame: baseline to 6 months
measure: Change in Depression From 6 Months to 1 Year
timeFrame: baseline to 6 months
measure: Change in Fatigue From Baseline to 6 Months
timeFrame: baseline to 6 months
measure: Change in Quality of Life From 6 Months to 1 Year
timeFrame: baseline to 6 months
measure: Change in Motivation From 6 Months to 1 Year, Measured by Autonomous Motivation Specific to Physical Activity
timeFrame: baseline to 6 months
measure: Acceptability, Measured Using Self-report Measures of Usability and Liking of the Apps
timeFrame: baseline to 6 months
measure: Play Experience, Measured Using the Play Experience Questionnaire
timeFrame: Measured at 3 months
measure: Change in Exercise Identity From Baseline to 6 Months
timeFrame: baseline to 6 months
measure: Narrative Engagement (Measured in Narrative Group Only), Measured Using the Narrative Engagement Scale
timeFrame: Measured at 3 months
measure: Character Identification (Measured in Narrative Group Only), Measured Using the Player Identification Scale
timeFrame: Measured at 3 months
measure: Change in Depression From Baseline to 6 Months
timeFrame: baseline to 6 months
measure: Change in Fatigue From 6 Months to 1 Year
timeFrame: baseline to 6 months
measure: Change in Sleep From Baseline to 6 Months
timeFrame: baseline to 6 months
measure: Maintenance of Physical Activity From 6 Months to 1 Year
timeFrame: baseline to 6 months
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Elizabeth Lyons, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.