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

This study has been completed.
Sponsor:
Information provided by:
HopeLab Foundation
ClinicalTrials.gov Identifier:
NCT00425139
First received: January 19, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Multi-Site Evaluation of a Video Game for Adolescents and Young Adults With Cancer

Resource links provided by NLM:


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

Ages Eligible for Study:   13 Years to 29 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425139

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

Additional Information:
No publications provided by HopeLab Foundation

Additional 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
Study First Received: January 19, 2007
Last Updated: January 19, 2007
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 30, 2014