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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00425139
• Other study ID #: HL-04-001
• Status: Completed
• Phase: N/A
• First received: January 19, 2007
• Last updated: March 19, 2015
• Start date: October 2004
• Est. completion date: November 2005

Study information

• Verified date: January 2007
• Source: HopeLab Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 29 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Neoplasms

Intervention

Behavioral:
• Re-Mission

Locations

Country	Name	City	State
Australia	Royal Children's Hospital	Parkville	Victoria
Canada	Calgary Alberta Children's Hospital	Calgary	Alberta
Canada	McMaster University	Hamilton	Ontario
Canada	Hôpital Ste-Justine	Montreal	Quebec
Canada	McGill Univ Health Ctr - Montreal Children's Hospital	Montreal	Quebec
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Québec	Ste-Foy	Quebec
United States	Children's Hospital of New Mexico	Albuquerque	New Mexico
United States	Children's Hospital of Austin	Austin	Texas
United States	Dana-Farber Cancer Institute and Children's Hospital	Boston	Massachusetts
United States	Driscoll Children's Hospital	Corpus Christi	Texas
United States	City of Hope National Medical Center	Duarte	California
United States	Children's Hospital of SW Florida / Lee Memorial Health System	Fort Myers	Florida
United States	Cook Children's Medical Center	Fort Worth	Texas
United States	DeVos Children's Hospital	Grand Rapids	Michigan
United States	St John Van Elslander Cancer Center	Grosse Pointe Woods	Michigan
United States	Kapiolani Medical Center	Honolulu	Hawaii
United States	Nemours Children's Clinic-Jacksonville	Jacksonville	Florida
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Los Angeles Children's Center for Cancer and Blood Disease	Los Angeles	California
United States	LSU Children's Hospital of New Orleans	New Orleans	Louisiana
United States	Children's Hospital of the King's Daughters	Norfolk	Virginia
United States	Children's Hospital of Orange County	Orange	California
United States	Lucile Packard Children's Hospital at Stanford	Palo Alto	California
United States	Doernbecher Childrens Hospital - OHSU	Portland	Oregon
United States	Legacy Emanuel Children's Cancer Program	Portland	Oregon
United States	Golisano Children's Hospital, University of Rochester	Rochester	New York
United States	Christus Santa Rosa Children's Hospital	San Antonio	Texas
United States	Deaconess Medical Center	Spokane	Washington
United States	Washington University	St. Louis	Missouri
United States	Children's Health Care - Minneapolis	St. Paul	Minnesota
United States	All Children's Hospital	St. Petersburg	Florida
United States	St. Joseph's Children's Hospital of Tampa	Tampa	Florida
United States	Warren Clinic / Saint Francis Hospital	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
HopeLab Foundation

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence
Primary	Self-efficacy
Primary	Quality of life

External Links

•   Sponsor's website
•   video game website