LEVEL UP: Video Games for Activity in Breast Cancer Survivors (LEVEL UP)
26 maj 2015 uppdaterad 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.
Studieöversikt
Status
Indragen
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Texas
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Galveston, Texas, Förenta staterna, 77555
- University of Texas Medical Branch
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
45 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in physical activity from baseline to 6 weeks
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in physical fitness from baseline to 6 weeks
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of participants who drop out of the study from baseline to 6 weeks
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2014
Primärt slutförande (Faktisk)
1 januari 2015
Avslutad studie (Faktisk)
1 januari 2015
Studieregistreringsdatum
Först inskickad
29 september 2014
Först inskickad som uppfyllde QC-kriterierna
29 september 2014
Första postat (Uppskatta)
2 oktober 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
27 maj 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 maj 2015
Senast verifierad
1 september 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 14-0240
- 1K07CA175141-01A1 (U.S.S. NIH-anslag/kontrakt)
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