Clinical trial NCT00425139: Evaluation of a Video Game for Adolescents and Young Adults With Cancer
Official title: Multi-site Evaluation of a Video Game for Adolescents and Young Adults With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Keywords: Cancer
Video game
Adolescent
Young adult
Lead sponsor: HopeLab Foundation
Sponsor class: OTHER
First posted: 2007-01-22
Enrollment: 375
Sex: ALL
Minimum age (years): 13
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence
measure: Self-efficacy
measure: Quality of life
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: Los Angeles Children's Center for Cancer and Blood Disease
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital at Stanford
state: California
city: Fort Myers
country: United States
facility: Children's Hospital of SW Florida / Lee Memorial Health System
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Clinic-Jacksonville
state: Florida
city: St. Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Children's Hospital of Tampa
state: Florida
city: Honolulu
country: United States
facility: Kapiolani Medical Center
state: Hawaii
city: New Orleans
country: United States
facility: LSU Children's Hospital of New Orleans
state: Louisiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute and Children's Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: DeVos Children's Hospital
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: St John Van Elslander Cancer Center
state: Michigan
city: St. Paul
country: United States
facility: Children's Health Care - Minneapolis
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Albuquerque
country: United States
facility: Children's Hospital of New Mexico
state: New Mexico
city: Rochester
country: United States
facility: Golisano Children's Hospital, University of Rochester
state: New York
city: Tulsa
country: United States
facility: Warren Clinic / Saint Francis Hospital
state: Oklahoma
city: Portland
country: United States
facility: Legacy Emanuel Children's Cancer Program
state: Oregon
city: Portland
country: United States
facility: Doernbecher Childrens Hospital - OHSU
state: Oregon
city: Austin
country: United States
facility: Children's Hospital of Austin
state: Texas
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: San Antonio
country: United States
facility: Christus Santa Rosa Children's Hospital
state: Texas
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
city: Spokane
country: United States
facility: Deaconess Medical Center
state: Washington
city: Parkville
country: Australia
facility: Royal Children's Hospital
state: Victoria
city: Calgary
country: Canada
facility: Calgary Alberta Children's Hospital
state: Alberta
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Montreal
country: Canada
facility: McGill Univ Health Ctr - Montreal Children's Hospital
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Ste-Justine
state: Quebec
city: Ste-Foy
country: Canada
facility: Centre Hospitalier Universitaire de Québec
state: Quebec
Study officials:
affiliation: HopeLab Foundation
name: Pamela M Kato
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kato PM, Cole SW, Bradlyn AS, Pollock BH. A video game improves behavioral outcomes in adolescents and young adults with cancer: a randomized trial. Pediatrics. 2008 Aug;122(2):e305-17. doi: 10.1542/peds.2007-3134.