- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00425139
Evaluation of a Video Game for Adolescents and Young Adults With Cancer
Multi-site Evaluation of a Video Game for Adolescents and Young Adults With Cancer
Studieöversikt
Detaljerad beskrivning
POPULATION: Approximately 340 patients will be enrolled in this study. Patients will be 13 to 29 years of age with any cancer (original diagnosis or relapse), currently receiving treatment and expected to be on treatment for at least 4 - 6 months following Baseline assessment, and able to communicate effectively in English, Spanish, or French. Approximately 170 patients will be enrolled in each of the two treatment groups. Each group will receive either the "Re-Mission" video game and a popular interactive video game, or just the popular interactive video game.
DESIGN: This is a multi-center, randomized trial, with patients randomized to one of two groups. One group (50% of patients) will receive the active intervention, which is the psycho-educational video game module called Re-Mission and a popular video game (hereafter "RE-MISSION") and another group (50 % of patients) will be in a game control group and receive a popular video game only (hereafter "GAME CONTROL. The games in the RE-MISSION and GAME CONTROL groups are delivered on identical mini, personal computers (hereafter "Mini-PC").
INTERVENTION: Each patient in the RE-MISSION group will be asked to play "Re-Mission" along with the popular video game for at least one hour a week for a period of ten to fourteen weeks. "Re-Mission" presents a 3-D environment in which the player can manipulate a humanoid character inside the virtual body of a patient with cancer. Game-play consists of guiding the character to destroy cancer cells and other "enemies" in the body (e.g., bacteria) while avoiding injury or weakness. During the process of playing the game and guiding the character through a series of missions, the player learns about chemotherapy and other medical treatments, health-promoting self-care behaviors, infections, and pain management. In addition, the game has also been designed to facilitate the patient's ability to share knowledge and concerns with others.
DURATION OF STUDY: 9 -12 months
Studietyp
Inskrivning
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Victoria
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Parkville, Victoria, Australien, 03052
- Royal Children's Hospital
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California
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Duarte, California, Förenta staterna, 91010
- City of Hope National Medical Center
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Los Angeles, California, Förenta staterna, 90027
- Los Angeles Children's Center for Cancer and Blood Disease
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Orange, California, Förenta staterna, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Förenta staterna, 94304
- Lucile Packard Children's Hospital at Stanford
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Florida
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Fort Myers, Florida, Förenta staterna, 33908
- Children's Hospital of SW Florida / Lee Memorial Health System
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Jacksonville, Florida, Förenta staterna, 32207
- Nemours Children's Clinic-Jacksonville
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St. Petersburg, Florida, Förenta staterna, 33701
- All Children's Hospital
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Tampa, Florida, Förenta staterna, 33607
- St. Joseph's Children's Hospital of Tampa
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96826
- Kapiolani Medical Center
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70118
- LSU Children's Hospital of New Orleans
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Dana-Farber Cancer Institute and Children's Hospital
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Michigan
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Grand Rapids, Michigan, Förenta staterna, 49503
- DeVos Children's Hospital
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Grosse Pointe Woods, Michigan, Förenta staterna, 48236
- St John Van Elslander Cancer Center
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Minnesota
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St. Paul, Minnesota, Förenta staterna, 55404
- Children's Health Care - Minneapolis
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Missouri
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Kansas City, Missouri, Förenta staterna, 64108
- Children's Mercy Hospital
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St. Louis, Missouri, Förenta staterna, 63110
- Washington University
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87131-0001
- Children's Hospital of New Mexico
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New York
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Rochester, New York, Förenta staterna, 14642
- Golisano Children's Hospital, University of Rochester
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Oklahoma
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Tulsa, Oklahoma, Förenta staterna, 74136
- Warren Clinic / Saint Francis Hospital
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Oregon
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Portland, Oregon, Förenta staterna, 97227
- Legacy Emanuel Children's Cancer Program
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Portland, Oregon, Förenta staterna, 97239
- Doernbecher Childrens Hospital - OHSU
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Texas
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Austin, Texas, Förenta staterna, 78701-1096
- Children's Hospital of Austin
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Corpus Christi, Texas, Förenta staterna, 78411
- Driscoll Children's Hospital
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Fort Worth, Texas, Förenta staterna, 76104
- Cook Children's Medical Center
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San Antonio, Texas, Förenta staterna, 78207
- Christus Santa Rosa Children's Hospital
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Virginia
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Norfolk, Virginia, Förenta staterna, 23507
- Children's Hospital of the King's Daughters
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Washington
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Spokane, Washington, Förenta staterna, 99204
- Deaconess Medical Center
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Alberta
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Calgary, Alberta, Kanada, T2T 5C7
- Calgary Alberta Children's Hospital
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Ontario
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Hamilton, Ontario, Kanada, L8N 3Z5
- McMaster University
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Ottawa, Ontario, Kanada, K1H 8LI
- Children's Hospital of Eastern Ontario
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Quebec
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Montreal, Quebec, Kanada, H3H 1P3
- McGill Univ Health Ctr - Montreal Children's Hospital
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Montreal, Quebec, Kanada, H3T 1C5
- Hôpital Ste-Justine
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Ste-Foy, Quebec, Kanada, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Male or female patient 13 to 29 years of age with a cancer diagnosis.
- Patient who is currently receiving treatment and is expected to remain on treatment for at least 4 - 6 months.
Exclusion Criteria:
- Patient who has a history of seizures due to photosensitivity.
- Patient who has been determined by the investigator to be incapable of following the study schedule or study directions for any reason.
- Patient who can not communicate effectively with study personnel in English, Spanish, or French.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
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Livskvalité
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Efterlevnad
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Självförmåga
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Pamela M Kato, HopeLab Foundation
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande
Avslutad studie
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
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