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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00425139
First Posted: January 22, 2007
Last Update Posted: March 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
HopeLab Foundation
  Purpose
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.

Condition Intervention
Neoplasms Behavioral: Re-Mission

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Multi-site Evaluation of a Video Game for Adolescents and Young Adults With Cancer

Further study details as provided by HopeLab Foundation:

Primary Outcome Measures:
  • Adherence
  • Self-efficacy
  • Quality of life

Estimated Enrollment: 375
Study Start Date: October 2004
Estimated Study Completion Date: November 2005
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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00425139


  Show 34 Study Locations
Sponsors and Collaborators
HopeLab Foundation
Investigators
Principal Investigator: Pamela M Kato HopeLab Foundation
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00425139     History of Changes
Other Study ID Numbers: HL-04-001
First Submitted: January 19, 2007
First Posted: January 22, 2007
Last Update Posted: March 20, 2015
Last Verified: January 2007

Keywords provided by HopeLab Foundation:
Cancer
Video game
Adolescent
Young adult