Status:
WITHDRAWN
LEVEL UP: Video Games for Activity in Breast Cancer Survivors
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Obesity
Eligibility:
FEMALE
45-75 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Female
- Aged 45 - 75
- Diagnosed with breast cancer within the past 10 years
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02255240
Start Date
September 1 2014
End Date
January 1 2015
Last Update
May 27 2015
Active Locations (1)
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1
University of Texas Medical Branch
Galveston, Texas, United States, 77555