Breast CancerLEVEL UPNCT02255240
LEVEL UP: Video Games for Activity in Breast Cancer Survivors
A study testing Physical activity intervention in people with Breast Cancer and Obesity, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Obesity
- What is being tested?
- Physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Aged 45 - 75
- Diagnosed with breast cancer within the past 10 years
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: LEVEL UP: Leveraging Electronic Videogames for Exercise and Leisure: Understanding Preferences of Breast Cancer Survivors
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.
Read the 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
- Being tested
- Physical activity intervention
- Keywords
- breast cancer, cancer, survivorship, cancer survivor, physical activity, video game, women, women's health
- Medical subject headings
- Breast Neoplasms, Obesity, Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Experimental | 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. Receives: Behavioral: Physical activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity from baseline to 6 weeks
Minutes of moderate-vigorous physical activity measured over a 7 day period
Measured: 6 weeks
Secondary outcomes (5)
Change in physical fitness from baseline to 6 weeks
We will use a six minute walk test to measure fitness
Measured: 6 weeks
Change in weight from baseline to 6 weeks
Weight will be measured using a calibrated scale
Measured: 6 weeks
Change in motivation from baseline to 6 weeks
We will measure autonomous motivation (intrinsic, integrated, identified, etc.) specific to physical activity
Measured: 6 weeks
Change in body function from baseline to 6 weeks
We will use the Senior Fitness Test to measure strength and body function
Measured: 6 weeks
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Relinquished grant funding due to receipt of another incompatible grant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elizabeth J Lyons, PhD, MPH, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255240
- Sponsor's protocol ID
- 14-0240
- Other IDs
- 1K07CA175141-01A1
- Acronym
- LEVEL UP
- Status last verified
- Sep 2014
- First submitted
- 29 Sep 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEVEL UP: Leveraging Electronic Videogames for Exercise and Leisure: Understanding Preferences of Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02255240
- Acronym / sponsor ID
- LEVEL UP / 14-0240
- Conditions
- Breast Cancer, Obesity
- Keywords
- breast cancer, cancer, survivorship, cancer survivor, physical activity, video game, women, women's health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Relinquished grant funding due to receipt of another incompatible grant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention | Experimental | Behavioral: Physical activity interventionThis 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Aged 45 - 75
- Diagnosed with breast cancer within the past 10 years
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity interventionParticipants 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. | Behavioural | Physical activity intervention |
Primary outcome
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
5 secondary outcomes
Change in physical fitness from baseline to 6 weeks
Time frame: 6 weeks
Change in weight from baseline to 6 weeks
Time frame: 6 weeks
Change in motivation from baseline to 6 weeks
Time frame: 6 weeks
Change in body function from baseline to 6 weeks
Time frame: 6 weeks
Change in quality of life from baseline to 6 weeks
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth J Lyons, PhD, MPH principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention in people with Breast Cancer and Obesity, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity from baseline to 6 weeks (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.