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Trial registered on ANZCTR


Registration number
ACTRN12606000487516
Ethics application status
Approved
Date submitted
15/11/2006
Date registered
27/11/2006
Date last updated
14/11/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Improved support for regional and remote paediatric oncology families: a randomised controlled trial of videotelephony
Scientific title
Improved support for regional and remote paediatric oncology families: a randomised controlled trial of videotelephony
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Newly diagnosed paediatric oncology patients 1464 0
Condition category
Condition code
Cancer 1560 1560 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: Access to usual support plus education, communication, counselling and monitoring with specialist multidisciplinary team members via a videotelephone service for a 12-week period following first discharge home. In addition, the videotelephone will be available to family members to facilitate intra-family support during inpatient stays
Intervention code [1] 1449 0
Other interventions
Comparator / control treatment
Usual support control group: Specialist multidisciplinary team members provide support either face-to-face during inpatient stays, outpatient clinic visits or home visits, or via telephone to families at a distance, plus intra-family support during inpatient stays via in-person visitation and/or telephone
Control group
Active

Outcomes
Primary outcome [1] 2155 0
Parental health related quality of life as measured using the Medical Outcome Survey (MOS) Short Form SF-12v2
Timepoint [1] 2155 0
Assessed at baseline and every 4 weeks
Secondary outcome [1] 3749 0
Parental informational and emotional support
Timepoint [1] 3749 0
assessed every 4 weeks
Secondary outcome [2] 3750 0
parental perceived stress
Timepoint [2] 3750 0
assessed every 4 weeks
Secondary outcome [3] 3751 0
parent reported patient quality of life
Timepoint [3] 3751 0
assessed every 4 weeks
Secondary outcome [4] 3752 0
parent reported sibling quality of life
Timepoint [4] 3752 0
assessed every 4 weeks
Secondary outcome [5] 3753 0
health care utilisation
Timepoint [5] 3753 0
assessed every 2 weeks
Secondary outcome [6] 3754 0
family financial costs
Timepoint [6] 3754 0
assessed every 2 weeks
Secondary outcome [7] 3755 0
parental satisfaction with care
Timepoint [7] 3755 0
assessed week 5 and week 12

Eligibility
Key inclusion criteria
Newly diagnosed male or female paediatric oncology patients and their families.
Minimum age
2 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were a home telephone connection of satisfactory quality cannot be installed.

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



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
162
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 1701 0
Government body
Name [1] 1701 0
National Health and Medical Research Council
Country [1] 1701 0
Australia
Primary sponsor type
University
Name
The University of Queensland Centre for Online Health
Address
Level 3 Foundation Building Royal Children's Hospital Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 1501 0
Hospital
Name [1] 1501 0
Haematology, Oncolgy and Stem Cell Transplant Unit
Address [1] 1501 0
Royal Children's Hospital, Brisbane
Herston QLD 4029
Country [1] 1501 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3155 0
Royal Children's Hospital
Ethics committee address [1] 3155 0
Ethics committee country [1] 3155 0
Australia
Date submitted for ethics approval [1] 3155 0
Approval date [1] 3155 0
23/10/2006
Ethics approval number [1] 3155 0
EC00175
Ethics committee name [2] 3156 0
Health Serivce Distric Ethics Committee
Ethics committee address [2] 3156 0
Ethics committee country [2] 3156 0
Australia
Date submitted for ethics approval [2] 3156 0
Approval date [2] 3156 0
23/10/2006
Ethics approval number [2] 3156 0
EC00175

Summary
Brief summary
To undertake a formal clinical trial using videotelephony to support regional and remote families returning home with a child newly diagnosed with cancer
Trial website
Trial related presentations / publications
Bensink M, Wootton R, Irving H, Hallahan A, Theodoros D, Russell T, Scuffham P, Barnett AG. Investigating the cost-effectiveness of videotelephone based support for newly diagnosed paediatric oncology patients and their families: design of a randomised controlled trial. BMC Health Services Research 2007;7(38) doi:10.1186/1472-6963-7-38

Bensink M, Armfield N, Irving H, Hallahan A, Theodoros D, Russell T, Barnett A, Scuffham P, Wootton R. A pilot study of videotelephone-based support for newly diagnosed paediatric oncology patients and their families. Journal or Telemedicine and Telecare, 2008, 14: 315-321
Public notes

Contacts
Principal investigator
Name 27383 0
Address 27383 0
Country 27383 0
Phone 27383 0
Fax 27383 0
Email 27383 0
Contact person for public queries
Name 10638 0
Mark Bensink
Address 10638 0
The University of Queensland Centre for Online Health
Royal Children's Hospital
Level 3 Foundation Building
Herston QLD 4029
Country 10638 0
Australia
Phone 10638 0
+61 7 33464756
Fax 10638 0
+61 7 33464705
Email 10638 0
[email protected]
Contact person for scientific queries
Name 1566 0
Mark Bensink
Address 1566 0
The University of Queensland Centre for Online Health
Royal Children's Hospital
Level 3 Foundation Building
Herston QLD 4029
Country 1566 0
Australia
Phone 1566 0
+61 7 33464756
Fax 1566 0
+61 7 33464705
Email 1566 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.