Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425139
Status:
COMPLETED
Last Update Posted:
2015-03-20
First Post:
2007-01-19
Brief Title:
Evaluation of a Video Game for Adolescents and Young Adults With Cancer
Sponsor:
HopeLab Foundation
Organization:
HopeLab Foundation
Study Overview
Official Title:
Multi-site Evaluation of a Video Game for Adolescents and Young Adults With Cancer
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 patients ability to share knowledge and concerns with others
DURATION OF STUDY 9 -12 months
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 eg 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 patients ability to share knowledge and concerns with others
DURATION OF STUDY 9 -12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None