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

Primary Purpose

Breast Cancer, Obesity

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical activity intervention
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, cancer, survivorship, cancer survivor, physical activity, video game, women, women's health

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Texas Medical Branch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical activity intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in physical activity from baseline to 6 weeks
Minutes of moderate-vigorous physical activity measured over a 7 day period

Secondary Outcome Measures

Change in physical fitness from baseline to 6 weeks
We will use a six minute walk test to measure fitness
Change in weight from baseline to 6 weeks
Weight will be measured using a calibrated scale
Change in motivation from baseline to 6 weeks
We will measure autonomous motivation (intrinsic, integrated, identified, etc.) specific to physical activity
Change in body function from baseline to 6 weeks
We will use the Senior Fitness Test to measure strength and body function
Change in quality of life from baseline to 6 weeks
We will use the Functional Assessment of Cancer Therapy - Breast measure to quantify quality of life

Full Information

First Posted
September 29, 2014
Last Updated
May 26, 2015
Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02255240
Brief Title
LEVEL UP: Video Games for Activity in Breast Cancer Survivors
Acronym
LEVEL UP
Official Title
LEVEL UP: Leveraging Electronic Videogames for Exercise and Leisure: Understanding Preferences of Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Relinquished grant funding due to receipt of another incompatible grant
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Obesity
Keywords
breast cancer, cancer, survivorship, cancer survivor, physical activity, video game, women, women's health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical activity intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity intervention
Intervention Description
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 Measure Information:
Title
Change in physical activity from baseline to 6 weeks
Description
Minutes of moderate-vigorous physical activity measured over a 7 day period
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in physical fitness from baseline to 6 weeks
Description
We will use a six minute walk test to measure fitness
Time Frame
6 weeks
Title
Change in weight from baseline to 6 weeks
Description
Weight will be measured using a calibrated scale
Time Frame
6 weeks
Title
Change in motivation from baseline to 6 weeks
Description
We will measure autonomous motivation (intrinsic, integrated, identified, etc.) specific to physical activity
Time Frame
6 weeks
Title
Change in body function from baseline to 6 weeks
Description
We will use the Senior Fitness Test to measure strength and body function
Time Frame
6 weeks
Title
Change in quality of life from baseline to 6 weeks
Description
We will use the Functional Assessment of Cancer Therapy - Breast measure to quantify quality of life
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Number of participants who drop out of the study from baseline to 6 weeks
Description
We will investigate the number of participants who drop out of the intervention group in comparison to similar studies
Time Frame
6 weeks
Title
Acceptability
Description
We will measure acceptability of the intervention components and tools using validated self-report measures and qualitative interviews/focus groups
Time Frame
6 weeks
Title
Number of participants who report adverse events
Description
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.
Time Frame
6 weeks
Title
Adherence
Description
We will use objective measures to investigate adherence to game play protocols (console logs, automatic postings to the console social network, etc.)
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth J Lyons, PhD, MPH
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States

12. IPD Sharing Statement

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LEVEL UP: Video Games for Activity in Breast Cancer Survivors

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