LEVEL UP: Video Games for Activity in Breast Cancer Survivors

NCT ID: NCT02255240

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-01-31

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.

Conditions

Breast Cancer; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical activity intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth J Lyons, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

University of Texas Medical Branch

Galveston, Texas, United States

Countries

United States

Other Identifiers

1K07CA175141-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-0240

Identifier Type: -

Identifier Source: org_study_id