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LEVEL UP: Video Games for Activity in Breast Cancer Survivors (LEVEL UP)

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ClinicalTrials.gov Identifier: NCT02255240
Recruitment Status : Withdrawn (Relinquished grant funding due to receipt of another incompatible grant)
First Posted : October 2, 2014
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Obesity Behavioral: Physical activity intervention Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: LEVEL UP: Leveraging Electronic Videogames for Exercise and Leisure: Understanding Preferences of Breast Cancer Survivors
Study Start Date : September 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015


Arm Intervention/treatment
Experimental: Physical activity intervention
This arm will receive the physical activity intervention, which consists of three individual meetings, weekly brief counseling phone calls for 6 weeks, and provision of a video game console with three active video games.
Behavioral: Physical activity intervention
Participants will receive counseling on self-regulatory skill building that has been adapted to complement the video games used. We anticipate that the games used will consist of fitness, sports, and dance games and will be played on a Wii U console. The games played will be chosen by each participant from a pool of potential appropriate games.




Primary Outcome Measures :
  1. Change in physical activity from baseline to 6 weeks [ Time Frame: 6 weeks ]
    Minutes of moderate-vigorous physical activity measured over a 7 day period


Secondary Outcome Measures :
  1. Change in physical fitness from baseline to 6 weeks [ Time Frame: 6 weeks ]
    We will use a six minute walk test to measure fitness

  2. Change in weight from baseline to 6 weeks [ Time Frame: 6 weeks ]
    Weight will be measured using a calibrated scale

  3. Change in motivation from baseline to 6 weeks [ Time Frame: 6 weeks ]
    We will measure autonomous motivation (intrinsic, integrated, identified, etc.) specific to physical activity

  4. Change in body function from baseline to 6 weeks [ Time Frame: 6 weeks ]
    We will use the Senior Fitness Test to measure strength and body function

  5. Change in quality of life from baseline to 6 weeks [ Time Frame: 6 weeks ]
    We will use the Functional Assessment of Cancer Therapy - Breast measure to quantify quality of life


Other Outcome Measures:
  1. Number of participants who drop out of the study from baseline to 6 weeks [ Time Frame: 6 weeks ]
    We will investigate the number of participants who drop out of the intervention group in comparison to similar studies

  2. Acceptability [ Time Frame: 6 weeks ]
    We will measure acceptability of the intervention components and tools using validated self-report measures and qualitative interviews/focus groups

  3. Number of participants who report adverse events [ Time Frame: 6 weeks ]
    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.

  4. Adherence [ Time Frame: 6 weeks ]
    We will use objective measures to investigate adherence to game play protocols (console logs, automatic postings to the console social network, etc.)



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255240


Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
National Cancer Institute (NCI)
Investigators
Principal Investigator: Elizabeth J Lyons, PhD, MPH University of Texas

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT02255240     History of Changes
Other Study ID Numbers: 14-0240
1K07CA175141-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: September 2014

Keywords provided by The University of Texas Medical Branch, Galveston:
breast cancer
cancer
survivorship
cancer survivor
physical activity
video game
women
women's health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases