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Evaluation of a Video Game for Adolescents and Young Adults With Cancer

19. marts 2015 opdateret af: HopeLab Foundation

Multi-site Evaluation of a Video Game for Adolescents and Young Adults With Cancer

The purpose of this study is to determine the effects of playing the interactive video game, Re-Mission, on patient outcomes, including adherence to medical treatment regimes, self-care behaviors, quality of life, stress, communication, control, and knowledge.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding

375

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
    • Victoria
      • Parkville, Victoria, Australien, 03052
        • Royal Children's Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2T 5C7
        • Calgary Alberta Children's Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University
      • Ottawa, Ontario, Canada, K1H 8LI
        • Children's Hospital of Eastern Ontario
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • McGill Univ Health Ctr - Montreal Children's Hospital
      • Montreal, Quebec, Canada, H3T 1C5
        • Hôpital Ste-Justine
      • Ste-Foy, Quebec, Canada, G1V 4G2
        • Centre Hospitalier Universitaire de Quebec
  • Forenede Stater
    • California
      • Duarte, California, Forenede Stater, 91010
        • City of Hope National Medical Center
      • Los Angeles, California, Forenede Stater, 90027
        • Los Angeles Children's Center for Cancer and Blood Disease
      • Orange, California, Forenede Stater, 92868
        • Children's Hospital of Orange County
      • Palo Alto, California, Forenede Stater, 94304
        • Lucile Packard Children's Hospital at Stanford
    • Florida
      • Fort Myers, Florida, Forenede Stater, 33908
        • Children's Hospital of SW Florida / Lee Memorial Health System
      • Jacksonville, Florida, Forenede Stater, 32207
        • Nemours Children's Clinic-Jacksonville
      • St. Petersburg, Florida, Forenede Stater, 33701
        • All Children's Hospital
      • Tampa, Florida, Forenede Stater, 33607
        • St. Joseph's Children's Hospital of Tampa
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96826
        • Kapiolani Medical Center
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70118
        • LSU Children's Hospital of New Orleans
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana-Farber Cancer Institute and Children's Hospital
    • Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • DeVos Children's Hospital
      • Grosse Pointe Woods, Michigan, Forenede Stater, 48236
        • St John Van Elslander Cancer Center
    • Minnesota
      • St. Paul, Minnesota, Forenede Stater, 55404
        • Children's Health Care - Minneapolis
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64108
        • Children's Mercy Hospital
      • St. Louis, Missouri, Forenede Stater, 63110
        • Washington University
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131-0001
        • Children's Hospital of New Mexico
    • New York
      • Rochester, New York, Forenede Stater, 14642
        • Golisano Children's Hospital, University of Rochester
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • Warren Clinic / Saint Francis Hospital
    • Oregon
      • Portland, Oregon, Forenede Stater, 97227
        • Legacy Emanuel Children's Cancer Program
      • Portland, Oregon, Forenede Stater, 97239
        • Doernbecher Childrens Hospital - OHSU
    • Texas
      • Austin, Texas, Forenede Stater, 78701-1096
        • Children's Hospital of Austin
      • Corpus Christi, Texas, Forenede Stater, 78411
        • Driscoll Children's Hospital
      • Fort Worth, Texas, Forenede Stater, 76104
        • Cook Children's Medical Center
      • San Antonio, Texas, Forenede Stater, 78207
        • Christus Santa Rosa Children's Hospital
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23507
        • Children's Hospital of The King's Daughters
    • Washington
      • Spokane, Washington, Forenede Stater, 99204
        • Deaconess Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

13 år til 29 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Male or female patient 13 to 29 years of age with a cancer diagnosis.
  2. Patient who is currently receiving treatment and is expected to remain on treatment for at least 4 - 6 months.

Exclusion Criteria:

  1. Patient who has a history of seizures due to photosensitivity.
  2. Patient who has been determined by the investigator to be incapable of following the study schedule or study directions for any reason.
  3. Patient who can not communicate effectively with study personnel in English, Spanish, or French.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Livskvalitet
Overholdelse
Self-efficacy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

HopeLab Foundation

Efterforskere

  • Ledende efterforsker: Pamela M Kato, HopeLab Foundation

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2004

Primær færdiggørelse

7. december 2022

Studieafslutning

1. november 2005

Datoer for studieregistrering

Først indsendt

19. januar 2007

Først indsendt, der opfyldte QC-kriterier

19. januar 2007

Først opslået (Skøn)

22. januar 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. marts 2015

Sidst verificeret

1. januar 2007

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • HL-04-001

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Neoplasmer

Kliniske forsøg med Re-Mission

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Rwanda

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner