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

March 19, 2015 updated by: HopeLab Foundation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

375

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 03052
        • Royal Children's Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2T 5C7
        • Calgary Alberta Children's Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University
      • Ottawa, Ontario, Canada, K1H 8LI
        • Children's Hospital of Eastern Ontario
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • McGill Univ Health Ctr - Montreal Children's Hospital
      • Montreal, Quebec, Canada, H3T 1C5
        • Hôpital Ste-Justine
      • Ste-Foy, Quebec, Canada, G1V 4G2
        • Centre Hospitalier Universitaire de Quebec
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Los Angeles, California, United States, 90027
        • Los Angeles Children's Center for Cancer and Blood Disease
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • Palo Alto, California, United States, 94304
        • Lucile Packard Children's Hospital at Stanford
    • Florida
      • Fort Myers, Florida, United States, 33908
        • Children's Hospital of SW Florida / Lee Memorial Health System
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Clinic-Jacksonville
      • St. Petersburg, Florida, United States, 33701
        • All Children's Hospital
      • Tampa, Florida, United States, 33607
        • St. Joseph's Children's Hospital of Tampa
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • LSU Children's Hospital of New Orleans
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute and Children's Hospital
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • DeVos Children's Hospital
      • Grosse Pointe Woods, Michigan, United States, 48236
        • St John Van Elslander Cancer Center
    • Minnesota
      • St. Paul, Minnesota, United States, 55404
        • Children's Health Care - Minneapolis
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
      • St. Louis, Missouri, United States, 63110
        • Washington University
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • Children's Hospital of New Mexico
    • New York
      • Rochester, New York, United States, 14642
        • Golisano Children's Hospital, University of Rochester
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Warren Clinic / Saint Francis Hospital
    • Oregon
      • Portland, Oregon, United States, 97227
        • Legacy Emanuel Children's Cancer Program
      • Portland, Oregon, United States, 97239
        • Doernbecher Childrens Hospital - OHSU
    • Texas
      • Austin, Texas, United States, 78701-1096
        • Children's Hospital of Austin
      • Corpus Christi, Texas, United States, 78411
        • Driscoll Children's Hospital
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center
      • San Antonio, Texas, United States, 78207
        • Christus Santa Rosa Children's Hospital
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Children's Hospital of The King's Daughters
    • Washington
      • Spokane, Washington, United States, 99204
        • Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 29 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Quality of life
Adherence
Self-efficacy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HopeLab Foundation

Investigators

  • Principal Investigator: Pamela M Kato, HopeLab Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion

December 7, 2022

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

January 19, 2007

First Submitted That Met QC Criteria

January 19, 2007

First Posted (Estimate)

January 22, 2007

Study Record Updates

Last Update Posted (Estimate)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HL-04-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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