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

NCT ID: NCT00425139

Last Updated: 2015-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-11-30

Brief Summary

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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

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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

Conditions

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Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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Re-Mission

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HopeLab Foundation

OTHER

Sponsor Role lead

Principal Investigators

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Pamela M Kato

Role: PRINCIPAL_INVESTIGATOR

HopeLab Foundation

Locations

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City of Hope National Medical Center

Duarte, California, United States

Site Status

Los Angeles Children's Center for Cancer and Blood Disease

Los Angeles, California, United States

Site Status

Children's Hospital of Orange County

Orange, California, United States

Site Status

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, United States

Site Status

Children's Hospital of SW Florida / Lee Memorial Health System

Fort Myers, Florida, United States

Site Status

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, United States

Site Status

All Children's Hospital

St. Petersburg, Florida, United States

Site Status

St. Joseph's Children's Hospital of Tampa

Tampa, Florida, United States

Site Status

Kapiolani Medical Center

Honolulu, Hawaii, United States

Site Status

LSU Children's Hospital of New Orleans

New Orleans, Louisiana, United States

Site Status

Dana-Farber Cancer Institute and Children's Hospital

Boston, Massachusetts, United States

Site Status

DeVos Children's Hospital

Grand Rapids, Michigan, United States

Site Status

St John Van Elslander Cancer Center

Grosse Pointe Woods, Michigan, United States

Site Status

Children's Health Care - Minneapolis

Saint Paul, Minnesota, United States

Site Status

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Children's Hospital of New Mexico

Albuquerque, New Mexico, United States

Site Status

Golisano Children's Hospital, University of Rochester

Rochester, New York, United States

Site Status

Warren Clinic / Saint Francis Hospital

Tulsa, Oklahoma, United States

Site Status

Legacy Emanuel Children's Cancer Program

Portland, Oregon, United States

Site Status

Doernbecher Childrens Hospital - OHSU

Portland, Oregon, United States

Site Status

Children's Hospital of Austin

Austin, Texas, United States

Site Status

Driscoll Children's Hospital

Corpus Christi, Texas, United States

Site Status

Cook Children's Medical Center

Fort Worth, Texas, United States

Site Status

Christus Santa Rosa Children's Hospital

San Antonio, Texas, United States

Site Status

Children's Hospital of the King's Daughters

Norfolk, Virginia, United States

Site Status

Deaconess Medical Center

Spokane, Washington, United States

Site Status

Royal Children's Hospital

Parkville, Victoria, Australia

Site Status

Calgary Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status

McMaster University

Hamilton, Ontario, Canada

Site Status

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Site Status

McGill Univ Health Ctr - Montreal Children's Hospital

Montreal, Quebec, Canada

Site Status

Hôpital Ste-Justine

Montreal, Quebec, Canada

Site Status

Centre Hospitalier Universitaire de Québec

Ste-Foy, Quebec, Canada

Site Status

Countries

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United States Australia Canada

References

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Kato PM, Cole SW, Bradlyn AS, Pollock BH. A video game improves behavioral outcomes in adolescents and young adults with cancer: a randomized trial. Pediatrics. 2008 Aug;122(2):e305-17. doi: 10.1542/peds.2007-3134.

Reference Type DERIVED
PMID: 18676516 (View on PubMed)

Related Links

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http://www.hopelab.org

Sponsor's website

http://www.re-mission.net

video game website

Other Identifiers

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HL-04-001

Identifier Type: -

Identifier Source: org_study_id

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