- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Descripción detallada
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
Tipo de estudio
Inscripción
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Victoria
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Parkville, Victoria, Australia, 03052
- Royal Children's Hospital
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Alberta
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Calgary, Alberta, Canadá, T2T 5C7
- Calgary Alberta Children's Hospital
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Ontario
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Hamilton, Ontario, Canadá, L8N 3Z5
- McMaster University
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Ottawa, Ontario, Canadá, K1H 8LI
- Children's Hospital of Eastern Ontario
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Quebec
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Montreal, Quebec, Canadá, H3H 1P3
- McGill Univ Health Ctr - Montreal Children's Hospital
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Montreal, Quebec, Canadá, H3T 1C5
- Hôpital Ste-Justine
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Ste-Foy, Quebec, Canadá, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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California
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Duarte, California, Estados Unidos, 91010
- City of Hope National Medical Center
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Los Angeles, California, Estados Unidos, 90027
- Los Angeles Children's Center for Cancer and Blood Disease
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Orange, California, Estados Unidos, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Estados Unidos, 94304
- Lucile Packard Children's Hospital at Stanford
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Florida
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Fort Myers, Florida, Estados Unidos, 33908
- Children's Hospital of SW Florida / Lee Memorial Health System
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Jacksonville, Florida, Estados Unidos, 32207
- Nemours Children's Clinic-Jacksonville
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St. Petersburg, Florida, Estados Unidos, 33701
- All Children's Hospital
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Tampa, Florida, Estados Unidos, 33607
- St. Joseph's Children's Hospital of Tampa
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96826
- Kapiolani Medical Center
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70118
- LSU Children's Hospital of New Orleans
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber Cancer Institute and Children's Hospital
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Michigan
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Grand Rapids, Michigan, Estados Unidos, 49503
- DeVos Children's Hospital
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Grosse Pointe Woods, Michigan, Estados Unidos, 48236
- St John Van Elslander Cancer Center
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Minnesota
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St. Paul, Minnesota, Estados Unidos, 55404
- Children's Health Care - Minneapolis
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Missouri
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Kansas City, Missouri, Estados Unidos, 64108
- Children's Mercy Hospital
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St. Louis, Missouri, Estados Unidos, 63110
- Washington University
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87131-0001
- Children's Hospital of New Mexico
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New York
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Rochester, New York, Estados Unidos, 14642
- Golisano Children's Hospital, University of Rochester
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74136
- Warren Clinic / Saint Francis Hospital
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Oregon
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Portland, Oregon, Estados Unidos, 97227
- Legacy Emanuel Children's Cancer Program
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Portland, Oregon, Estados Unidos, 97239
- Doernbecher Childrens Hospital - OHSU
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Texas
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Austin, Texas, Estados Unidos, 78701-1096
- Children's Hospital of Austin
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Corpus Christi, Texas, Estados Unidos, 78411
- Driscoll Children's Hospital
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Fort Worth, Texas, Estados Unidos, 76104
- Cook Children's Medical Center
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San Antonio, Texas, Estados Unidos, 78207
- Christus Santa Rosa Children's Hospital
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Virginia
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Norfolk, Virginia, Estados Unidos, 23507
- Children's Hospital of The King's Daughters
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Washington
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Spokane, Washington, Estados Unidos, 99204
- Deaconess Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Calidad de vida
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Adherencia
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Autoeficacia
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Pamela M Kato, HopeLab Foundation
Publicaciones y enlaces útiles
Publicaciones Generales
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- HL-04-001
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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