Multi-site Evaluation of a Video Game for Adolescents and Young Adults With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 375
- 试验地点
- 68
- 主要终点
- Adherence
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Adherence
Self-efficacy
Quality of life
次要结局
未报告次要终点