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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
Scientific title
Multi-site Evaluation of a Video Game for Adolescents and Young Adults With Cancer
Secondary ID [1] 0 0
HL-04-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Re-Mission

Behaviour: Re-Mission
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adherence
Timepoint [1] 0 0
Primary outcome [2] 0 0
Self-efficacy
Timepoint [2] 0 0
Primary outcome [3] 0 0
Quality of life
Timepoint [3] 0 0

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.
Minimum age
13 Years
Maximum age
29 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
03052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Mexico
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
HopeLab Foundation
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00425139
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pamela M Kato
Address 0 0
HopeLab Foundation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries