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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Breast Cancer
• Intervention / Treatment: Behavioral: Game intervention; Behavioral: Standard intervention

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: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77550
      • The University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Minutes Per Day of Physical Activity	Minutes of moderate-vigorous physical activity per day (averaged over a 7 day period) at baseline and 6 months.	baseline and 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	We will use a 6 minute walk test to measure fitness, measured in feet walked in six minutes on a pre-marked indoor course	baseline to 6 months
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Chair Stand Measure	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.	baseline to 6 months
Change in Weight From Baseline to 6 Months	We will measure weight using a calibrated scale	baseline to 6 months
Change in Physical 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'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.	baseline to 6 months
Change in Intrinsic Motivation From Baseline to 6 Months, Measured by Intrinsic Motivation Specific to Physical Activity	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.	baseline to 6 months
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	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.	baseline to 6 months
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	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	baseline to 6 Months
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	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	baseline to 6 Months
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	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	baseline to 6 Months
Change in Identified Regulation From Baseline to 6 Months, Measured by Identified Regulation Specific to Physical Activity	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.	baseline to 6 Months
Change in Integrated Regulation From Baseline to 6 Months, Measured by Integrated Regulation Specific to Physical Activity	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.	baseline to 6 Months
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Arm Curl Measure	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.	baseline to 6 Months
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Sit and Reach Measure	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.	baseline to 6 Months
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Back Scratch Measure	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.	baseline to 6 Months
Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's 8 Foot Up and Go Test	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.	baseline to 6 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, measured in feet walked in six minutes on a pre-marked indoor course	baseline to 6 months
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, with a higher number indicating greater function	baseline to 6 months
Change in Sleep From 6 Months to 1 Year	We will use a computerized PROMIS measure specific to cancer survivors	baseline to 6 months
Change in Weight From 6 Months to 1 Year	Weight will be measured using a calibrated scale	baseline to 6 months
Adherence, Measured by Objective Measures to Investigate Adherence to Study Protocols	We will use objective measures to investigate adherence to study protocols (game usage, monitor usage, phone calls completed, assessments attended, etc.)	1 year
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
Change in Anxiety From Baseline to 6 Months	We will use a computerized PROMIS measure to investigate anxiety (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 - Anxiety). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less anxiety) than the population.	baseline to 6 months
Change in Depression From 6 Months to 1 Year	We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 - Depression)	baseline to 6 months
Change in Fatigue From Baseline to 6 Months	We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 Fatigue). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less fatigued) than the population.	baseline to 6 months
Change in Quality of Life From 6 Months to 1 Year	We will use the Functional Assessment of Cancer Therapy - Breast measure	baseline to 6 months
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, specifically subscales for autonomous motivation (intrinsic, integrated, identified regulation). We will use items from P.M. Wilson and colleague's expansion of the Behavioral Regulation in Exercise Questionnaire-2 to include integrated regulation.	baseline to 6 months
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	baseline to 6 months
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
Change in Exercise Identity From Baseline to 6 Months	We will use the Exercise Identity Scale to investigate exercise beliefs and exercise role identity	baseline to 6 months
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
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
Change in Depression From Baseline to 6 Months	We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 - Depression). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less depressed) than the population.	baseline to 6 months
Change in Fatigue From 6 Months to 1 Year	We will use a computerized PROMIS measure specific to cancer patients/survivors	baseline to 6 months
Change in Sleep From Baseline to 6 Months	We will use a computerized PROMIS measure (Patient Reported Outcomes Measurement Information System PROMIS Bank v1.0 - Sleep-Related Impairment). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower than the population (more/less impairment).	baseline to 6 months
Maintenance of Physical Activity From 6 Months to 1 Year	Minutes of moderate-vigorous physical activity measured over a 7 day period	baseline to 6 months

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Elizabeth Lyons, PhD, MPH, University of Texas

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: January 9, 2015
• First Submitted That Met QC Criteria: January 13, 2015
• First Posted (Estimated): January 19, 2015

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; cancer survivor; survivorship; women; women's health; mhealth; video game; narrative; story
• Other Study ID Numbers: 14-0376