Clinical trial NCT02255240: LEVEL UP: Video Games for Activity in Breast Cancer Survivors
Official title: LEVEL UP: Leveraging Electronic Videogames for Exercise and Leisure: Understanding Preferences of Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Obesity
Keywords: breast cancer
cancer
survivorship
cancer survivor
physical activity
video game
women
women's health
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-10-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test an intervention that uses home console video games to encourage increased physical activity among postmenopausal breast cancer survivors.

Detailed description: This research project includes qualitative and quantitative formative research leading to a randomized controlled feasibility trial of a video game-based physical activity intervention. First, we will investigate exercise protocols implemented over 6 weeks in 20 breast cancer survivors. We will choose a console and six games for inclusion in the trial, based on measured energy expenditure and enjoyment. We will create refined exercise protocols using these games and insights from participants. Second, we will test an intervention that uses active video games for implementation of motivating exercise and provision of behavioral tools (e.g., tracking of progress towards goals). Participants in a pre-pilot trial (N = 10) will receive weekly brief telephone counseling over 6 weeks. Feasibility measurement will include attrition, self-reported acceptability, and objective measures of video game play taken from game console data.

Eligibility criteria: Inclusion Criteria:

* Female
* Aged 45 - 75
* Diagnosed with breast cancer within the past 10 years

Exclusion Criteria:

* Chemotherapy or radiation treatment in the past six months
* Surgery in the past six months
* Evidence of disease recurrence
* Unable to read and understand English
* Unable to see a TV screen from several feet away
* Unable to find transportation to the study location
* No Internet access in the home (only for intervention portion of the study)
* Participant is active (60 minutes of moderate-vigorous intensity activity per week or more)
* BMI is under 18.5 kg/m2 or over 40 kg/m2
* Participant reports psychological issues that would interfere with study completion. Examples will be provided to illustrate potential psychological issues, such as dementia or schizophrenia.
* Inadequate performance on Senior Fitness Test, indicating inability to engage in video game exercise procedures (total score \< 9 out of 12)
* 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
* Unable to walk, jump, and jog as may be required by some games (self-report)
* Report current symptoms of alcohol or substance dependence
* Plans to move away from the Galveston-Houston area or to be out of town for more than 1 week during the study period
* Unwillingness to report drugs taken for comorbidities such as hypertension or diabetes
* Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
* Report a history of orthopedic complications that would prevent optimal participation in the physical activities prescribed (e.g., heel spurs, severe arthritis)
* Clinical judgment concerning safety
* Currently participating in a physical activity or weight program/research study
* Currently pregnant or nursing
* No TV is available in the participant's home
* Currently on a weight loss diet or has lost more than 5% body weight in the previous 6 months
* Current smoker
* Game console to be used in the study is already available in the home
* Another member of the household is a participant or staff member on this trial

Primary outcomes:
measure: Change in physical activity from baseline to 6 weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in physical fitness from baseline to 6 weeks
timeFrame: 6 weeks
measure: Change in weight from baseline to 6 weeks
timeFrame: 6 weeks
measure: Change in motivation from baseline to 6 weeks
timeFrame: 6 weeks
measure: Change in body function from baseline to 6 weeks
timeFrame: 6 weeks
measure: Change in quality of life from baseline to 6 weeks
timeFrame: 6 weeks
Other outcomes:
measure: Number of participants who drop out of the study from baseline to 6 weeks
timeFrame: 6 weeks
measure: Acceptability
timeFrame: 6 weeks
measure: Number of participants who report adverse events
timeFrame: 6 weeks
measure: Adherence
timeFrame: 6 weeks
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Elizabeth J Lyons, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: