- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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
연구 유형
등록
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Duarte, California, 미국, 91010
- City of Hope National Medical Center
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Los Angeles, California, 미국, 90027
- Los Angeles Children's Center for Cancer and Blood Disease
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Orange, California, 미국, 92868
- Children's Hospital of Orange County
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Palo Alto, California, 미국, 94304
- Lucile Packard Children's Hospital at Stanford
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Florida
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Fort Myers, Florida, 미국, 33908
- Children's Hospital of SW Florida / Lee Memorial Health System
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Jacksonville, Florida, 미국, 32207
- Nemours Children's Clinic-Jacksonville
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St. Petersburg, Florida, 미국, 33701
- All Children's Hospital
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Tampa, Florida, 미국, 33607
- St. Joseph's Children's Hospital of Tampa
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Hawaii
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Honolulu, Hawaii, 미국, 96826
- Kapiolani Medical Center
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Louisiana
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New Orleans, Louisiana, 미국, 70118
- LSU Children's Hospital of New Orleans
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Dana-Farber Cancer Institute and Children's Hospital
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Michigan
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Grand Rapids, Michigan, 미국, 49503
- DeVos Children's Hospital
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Grosse Pointe Woods, Michigan, 미국, 48236
- St John Van Elslander Cancer Center
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Minnesota
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St. Paul, Minnesota, 미국, 55404
- Children's Health Care - Minneapolis
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Missouri
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Kansas City, Missouri, 미국, 64108
- Children's Mercy Hospital
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St. Louis, Missouri, 미국, 63110
- Washington University
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New Mexico
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Albuquerque, New Mexico, 미국, 87131-0001
- Children's Hospital of New Mexico
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New York
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Rochester, New York, 미국, 14642
- Golisano Children's Hospital, University of Rochester
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Oklahoma
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Tulsa, Oklahoma, 미국, 74136
- Warren Clinic / Saint Francis Hospital
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Oregon
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Portland, Oregon, 미국, 97227
- Legacy Emanuel Children's Cancer Program
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Portland, Oregon, 미국, 97239
- Doernbecher Childrens Hospital - OHSU
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Texas
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Austin, Texas, 미국, 78701-1096
- Children's Hospital of Austin
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Corpus Christi, Texas, 미국, 78411
- Driscoll Children's Hospital
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Fort Worth, Texas, 미국, 76104
- Cook Children's Medical Center
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San Antonio, Texas, 미국, 78207
- Christus Santa Rosa Children's Hospital
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Virginia
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Norfolk, Virginia, 미국, 23507
- Children's Hospital of The King's Daughters
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Washington
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Spokane, Washington, 미국, 99204
- Deaconess Medical Center
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Alberta
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Calgary, Alberta, 캐나다, T2T 5C7
- Calgary Alberta Children's Hospital
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Ontario
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Hamilton, Ontario, 캐나다, L8N 3Z5
- McMaster University
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Ottawa, Ontario, 캐나다, K1H 8LI
- Children's Hospital of Eastern Ontario
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Quebec
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Montreal, Quebec, 캐나다, H3H 1P3
- McGill Univ Health Ctr - Montreal Children's Hospital
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Montreal, Quebec, 캐나다, H3T 1C5
- Hôpital Ste-Justine
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Ste-Foy, Quebec, 캐나다, G1V 4G2
- Centre Hospitalier Universitaire de Quebec
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Victoria
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Parkville, Victoria, 호주, 03052
- Royal Children's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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삶의 질
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부착
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자기효능감
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공동 작업자 및 조사자
수사관
- 수석 연구원: Pamela M Kato, HopeLab Foundation
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료
연구 완료
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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