Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000312549
Ethics application status
Approved
Date submitted
17/07/2006
Date registered
20/07/2006
Date last updated
14/11/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving intra-family support during paediatric bone marrow transplantation: a randomised controlled exploratory study of videotelephony
Scientific title
Improving intra-family support during paediatric bone marrow transplantation: a randomised controlled exploratory study of videotelephony
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric oncology bone marrow transplantation 1283 0
Condition category
Condition code
Cancer 1370 1370 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Access to usual support plus intra-family communication, and social worker support and counselling via videotelephone for the duration of transplant related hospitalisation. Information will be collected from parents for the duration of transplant related hospitalisation to a maximum of 6 months
Intervention code [1] 1209 0
Other interventions
Comparator / control treatment
Usual support via telephone (ad hoc support is provided to families during business hours) and face-to-face visits (the number and duration of in-patient stays and out-patient visits is variable depending on place of residence, disease and response to treatment)
Control group
Active

Outcomes
Primary outcome [1] 1873 0
Parental health related quality of life as measured using the Medical Outcome Survey (MOS) Short Form SF-12 v2
Timepoint [1] 1873 0
Assessed at baseline and every 4 weeks for 16 weeks
Secondary outcome [1] 3302 0
Parental informational and emotional support
Timepoint [1] 3302 0
Assessed every 4 weeks
Secondary outcome [2] 3303 0
Parental perceived stress
Timepoint [2] 3303 0
Assessed every 4 weeks
Secondary outcome [3] 3304 0
Parent reported patient quality of life
Timepoint [3] 3304 0
Assessed every 4 weeks
Secondary outcome [4] 3305 0
Parent reported sibling quality of life
Timepoint [4] 3305 0
Assessed every 4 weeks
Secondary outcome [5] 3306 0
Health care utilisation
Timepoint [5] 3306 0
Assessed every 2 weeks
Secondary outcome [6] 3307 0
Family finacial costs
Timepoint [6] 3307 0
Assessed every 2 weeks
Secondary outcome [7] 3308 0
Parental satisfaction with care
Timepoint [7] 3308 0
Assessed week 5 and at time of discharge.

Eligibility
Key inclusion criteria
Paediatric oncology patients requiring bone marrow transplantation.
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 quailty can not 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)
A computer generated table of random numbers will be used. Even numbers will denote allocation to the control group and odd numbers to the intervention group. Allocations to either group based on the table of random numbers will be written on a piece of paper and sealed in sequentially numbered opaque envelop by an individual with no connection to the trial. As families are enrolled in the trial, the research assistant will obtain information on allocation from the envelopes in sequential order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 203 0
4029

Funding & Sponsors
Funding source category [1] 1505 0
Charities/Societies/Foundations
Name [1] 1505 0
Royal Children's Hospital Foundation
Country [1] 1505 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] 1322 0
Hospital
Name [1] 1322 0
The Royal Children's Hospital Paediatric Haematology, Oncology and Bone Marrow Transplant Unit
Address [1] 1322 0
Herston Road, Herston QLD 4029
Country [1] 1322 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2926 0
Royal Children's Hospital Brisbane
Ethics committee address [1] 2926 0
Ethics committee country [1] 2926 0
Australia
Date submitted for ethics approval [1] 2926 0
Approval date [1] 2926 0
21/03/2005
Ethics approval number [1] 2926 0

Summary
Brief summary
To determine whether videotelephony is an effective means of improving support during paediatric bone marrow transplantation at a metropolitan hospital
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35923 0
Address 35923 0
Country 35923 0
Phone 35923 0
Fax 35923 0
Email 35923 0
Contact person for public queries
Name 10398 0
Mark Bensink
Address 10398 0
The University of Queensland Centre for Online Health Level 3 Foundation Building Royal Children's Hospital, Herston QLD 4029
Country 10398 0
Australia
Phone 10398 0
07 3346 4754
Fax 10398 0
07 3346 4705
Email 10398 0
[email protected]
Contact person for scientific queries
Name 1326 0
Mark Bensink
Address 1326 0
The University of Queensland Centre for Online Health Level 3 Foundation Building Royal Children's Hospital Herston QLD 4029
Country 1326 0
Australia
Phone 1326 0
07 3346 4756
Fax 1326 0
07 3346 4705
Email 1326 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.