LEVEL UP: Video Games for Activity in Breast Cancer Survivors

Breast Cancer Clinical Trial

— LEVEL UP  

Official title:

LEVEL UP: Leveraging Electronic Videogames for Exercise and Leisure: Understanding Preferences of Breast Cancer Survivors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02255240
• Other study ID #: 14-0240
• Secondary ID: 1K07CA175141-01A
• Status: Withdrawn
• Phase: N/A
• First received: September 29, 2014
• Last updated: May 26, 2015
• Start date: September 2014
• Est. completion date: January 2015

Study information

• Verified date: September 2014
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants who drop out of the study from baseline to 6 weeks	We will investigate the number of participants who drop out of the intervention group in comparison to similar studies	6 weeks	No
Other	Acceptability	We will measure acceptability of the intervention components and tools using validated self-report measures and qualitative interviews/focus groups	6 weeks	No
Other	Number of participants who report adverse events	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.	6 weeks	Yes
Other	Adherence	We will use objective measures to investigate adherence to game play protocols (console logs, automatic postings to the console social network, etc.)	6 weeks	No
Primary	Change in physical activity from baseline to 6 weeks	Minutes of moderate-vigorous physical activity measured over a 7 day period	6 weeks	No
Secondary	Change in physical fitness from baseline to 6 weeks	We will use a six minute walk test to measure fitness	6 weeks	No
Secondary	Change in weight from baseline to 6 weeks	Weight will be measured using a calibrated scale	6 weeks	No
Secondary	Change in motivation from baseline to 6 weeks	We will measure autonomous motivation (intrinsic, integrated, identified, etc.) specific to physical activity	6 weeks	No
Secondary	Change in body function from baseline to 6 weeks	We will use the Senior Fitness Test to measure strength and body function	6 weeks	No
Secondary	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	6 weeks	No