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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00425139
Registration number
NCT00425139
Ethics application status
Date submitted
19/01/2007
Date registered
22/01/2007
Date last updated
20/03/2015
Titles & IDs
Public title
Evaluation of a Video Game for Adolescents and Young Adults With Cancer
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Scientific title
Multi-site Evaluation of a Video Game for Adolescents and Young Adults With Cancer
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Secondary ID [1]
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HL-04-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neoplasms
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - Re-Mission
Behaviour: Re-Mission
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Adherence
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Assessment method [1]
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Timepoint [1]
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Primary outcome [2]
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Self-efficacy
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Assessment method [2]
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Timepoint [2]
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Primary outcome [3]
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Quality of life
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Assessment method [3]
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Timepoint [3]
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Eligibility
Key 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.
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Minimum age
13
Years
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Maximum age
29
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Supportive Care
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Children's Hospital - Parkville
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Recruitment postcode(s) [1]
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03052 - Parkville
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Florida
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Hawaii
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Louisiana
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Massachusetts
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Michigan
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Minnesota
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Missouri
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New Mexico
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New York
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Oklahoma
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Oregon
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Texas
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Virginia
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Washington
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Canada
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Alberta
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Canada
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Ontario
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Country [18]
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Canada
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State/province [18]
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Quebec
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Funding & Sponsors
Primary sponsor type
Other
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Name
HopeLab Foundation
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00425139
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pamela M Kato
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Address
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HopeLab Foundation
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Phone
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00425139
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