NeoplasmsNCT00425139
Evaluation of a Video Game for Adolescents and Young Adults With Cancer
A study testing Re-Mission in people with Neoplasms, run by HopeLab Foundation at 34 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 29 years
- Conditions the study is for
- Neoplasms
- What is being tested?
- Re-Mission
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 375 participants
- Where
- 34 sitesin 3 countries
- Study dates
- Oct 2004to Nov 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
34 sites in 3 countries.
34 sites in 3 countries
United States27 sites
Children's Hospital of New Mexico
Albuquerque, New Mexico, 87131-0001
Children's Hospital of Austin
Austin, Texas, 78701-1096
Dana-Farber Cancer Institute and Children's Hospital
Boston, Massachusetts, 02115
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
City of Hope National Medical Center
Duarte, California, 91010
Children's Hospital of SW Florida / Lee Memorial Health System
Fort Myers, Florida, 33908
Cook Children's Medical Center
Fort Worth, Texas, 76104
DeVos Children's Hospital
Grand Rapids, Michigan, 49503
St John Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, 48236
Kapiolani Medical Center
Honolulu, Hawaii, 96826
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
Children's Mercy Hospital
Kansas City, Missouri, 64108
Los Angeles Children's Center for Cancer and Blood Disease
Los Angeles, California, 90027
LSU Children's Hospital of New Orleans
New Orleans, Louisiana, 70118
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
Children's Hospital of Orange County
Orange, California, 92868
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
Legacy Emanuel Children's Cancer Program
Portland, Oregon, 97227
Doernbecher Childrens Hospital - OHSU
Portland, Oregon, 97239
Golisano Children's Hospital, University of Rochester
Rochester, New York, 14642
Children's Health Care - Minneapolis
Saint Paul, Minnesota, 55404
Christus Santa Rosa Children's Hospital
San Antonio, Texas, 78207
Deaconess Medical Center
Spokane, Washington, 99204
Washington University
St Louis, Missouri, 63110
All Children's Hospital
St. Petersburg, Florida, 33701
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, 33607
Warren Clinic / Saint Francis Hospital
Tulsa, Oklahoma, 74136
Canada6 sites
Calgary Alberta Children's Hospital
Calgary, Alberta, T2T 5C7
McMaster University
Hamilton, Ontario, L8N 3Z5
McGill Univ Health Ctr - Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Hôpital Ste-Justine
Montreal, Quebec, H3T 1C5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8LI
Centre Hospitalier Universitaire de Québec
Ste-Foy, Quebec, G1V 4G2
About this study
Official title: 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.
Read the 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
- Conditions
- Neoplasms
- Being tested
- Re-Mission
- Keywords
- Cancer, Video game, Adolescent, Young adult
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-MissionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Self-efficacy
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study startOct 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 375 participants
Sponsor and investigators
- Lead sponsor
- HopeLab Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Pamela M Kato, Principal investigator, HopeLab Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425139
- Sponsor's protocol ID
- HL-04-001
- Status last verified
- Jan 2007
- First submitted
- 19 Jan 2007
- Last updated
- 20 Mar 2015
- Results posted
- No
Publications
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.
PubMed 18676516
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site Evaluation of a Video Game for Adolescents and Young Adults With Cancer
- ClinicalTrials.gov ID
- NCT00425139
- Acronym / sponsor ID
- HL-04-001
- Conditions
- Neoplasms
- Keywords
- Cancer, Video game, Adolescent, Young adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants
- Lead sponsor
- HopeLab FoundationUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- Nov 2005
- First posted
- 22 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Re-Mission | Behavioural | – |
Primary outcome
Adherence
Self-efficacy
Quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
- Derived from this study: PubMed 18676516Kato 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.
- Sponsor's websiteLink provided by the sponsor.
- video game websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela M Kato principal investigator
HopeLab Foundation
34 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-Mission in people with Neoplasms, run by HopeLab Foundation at 34 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00425139, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015.