LEVEL UP: Video Games for Activity in Breast Cancer Survivors (LEVEL UP)
26 mei 2015 bijgewerkt door: The University of Texas Medical Branch, Galveston
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.
Studie Overzicht
Toestand
Ingetrokken
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Texas
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Galveston, Texas, Verenigde Staten, 77555
- University of Texas Medical Branch
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
45 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in physical activity from baseline to 6 weeks
Tijdsspanne: 6 weeks
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Minutes of moderate-vigorous physical activity measured over a 7 day period
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6 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in physical fitness from baseline to 6 weeks
Tijdsspanne: 6 weeks
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We will use a six minute walk test to measure fitness
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6 weeks
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Change in weight from baseline to 6 weeks
Tijdsspanne: 6 weeks
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Weight will be measured using a calibrated scale
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6 weeks
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Change in motivation from baseline to 6 weeks
Tijdsspanne: 6 weeks
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We will measure autonomous motivation (intrinsic, integrated, identified, etc.) specific to physical activity
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6 weeks
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Change in body function from baseline to 6 weeks
Tijdsspanne: 6 weeks
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We will use the Senior Fitness Test to measure strength and body function
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6 weeks
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Change in quality of life from baseline to 6 weeks
Tijdsspanne: 6 weeks
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We will use the Functional Assessment of Cancer Therapy - Breast measure to quantify quality of life
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6 weeks
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of participants who drop out of the study from baseline to 6 weeks
Tijdsspanne: 6 weeks
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We will investigate the number of participants who drop out of the intervention group in comparison to similar studies
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6 weeks
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Acceptability
Tijdsspanne: 6 weeks
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We will measure acceptability of the intervention components and tools using validated self-report measures and qualitative interviews/focus groups
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6 weeks
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Number of participants who report adverse events
Tijdsspanne: 6 weeks
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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.
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6 weeks
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Adherence
Tijdsspanne: 6 weeks
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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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6 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 september 2014
Primaire voltooiing (Werkelijk)
1 januari 2015
Studie voltooiing (Werkelijk)
1 januari 2015
Studieregistratiedata
Eerst ingediend
29 september 2014
Eerst ingediend dat voldeed aan de QC-criteria
29 september 2014
Eerst geplaatst (Schatting)
2 oktober 2014
Updates van studierecords
Laatste update geplaatst (Schatting)
27 mei 2015
Laatste update ingediend die voldeed aan QC-criteria
26 mei 2015
Laatst geverifieerd
1 september 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 14-0240
- 1K07CA175141-01A1 (Subsidie/contract van de Amerikaanse NIH)
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