Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 45 Years and 75 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

The University of Texas Medical Branch
Galveston, Texas 77550
Contact:
Eloisa Martinez
409-266-9643
esmartin@utmb.edu

More Details

NCT ID
NCT02341235
Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Eloisa Martinez
409-266-9643
esmartin@utmb.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.