LEVEL UP: Video Games for Activity in Breast Cancer Survivors (LEVEL UP)
26. mai 2015 oppdatert av: 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.
Studieoversikt
Status
Tilbaketrukket
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
Texas
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Galveston, Texas, Forente stater, 77555
- University of Texas Medical Branch
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
45 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in physical activity from baseline to 6 weeks
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in physical fitness from baseline to 6 weeks
Tidsramme: 6 weeks
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of participants who drop out of the study from baseline to 6 weeks
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2014
Primær fullføring (Faktiske)
1. januar 2015
Studiet fullført (Faktiske)
1. januar 2015
Datoer for studieregistrering
Først innsendt
29. september 2014
Først innsendt som oppfylte QC-kriteriene
29. september 2014
Først lagt ut (Anslag)
2. oktober 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
27. mai 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. mai 2015
Sist bekreftet
1. september 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14-0240
- 1K07CA175141-01A1 (U.S. NIH-stipend/kontrakt)
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