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



Status:Recruiting
Conditions:Breast Cancer, Cancer, Obesity Weight Loss
Therapuetic Areas:Endocrinology, Oncology
Healthy:No
Age Range:45 - 75
Updated:7/14/2018
Start Date:February 2015
End Date:December 2020
Contact:Eloisa Martinez
Email:esmartin@utmb.edu
Phone:409-266-9643

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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.

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.

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
We found this trial at
1
site
301 University Blvd
Galveston, Texas 77555
(409) 772-1011
Principal Investigator: Elizabeth J Lyons, PhD, MPH
Phone: 409-266-9643
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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from
Galveston, TX
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