Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000311550
Ethics application status
Approved
Date submitted
17/07/2006
Date registered
20/07/2006
Date last updated
8/04/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving paediatric palliative care for rural and remote families: a randomised controlled exploratory study of videotelephony
Scientific title
Improving paediatric palliative care for rural and remote families: 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 palliative care 1282 0
Condition category
Condition code
Cancer 1369 1369 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Access to usual support plus education, communication, counselling and monitoring with specialist multidisciplinary team members via videotelephone for the duration of palliative care. Information will be collected for the duration of palliation to a maximum of 6 months
Intervention code [1] 1208 0
Other interventions
Comparator / control treatment
Usual support via telephone (ad hoc support is provided to families 24-hours a day 7 days a week) and face-to-face visits (the number and duration of home visits and out-patient visits is variable depending on place of residence, disease and care requirments)
Control group
Active

Outcomes
Primary outcome [1] 1872 0
Parental health related quality of life as measured using the Medical Outcome Survey (MOS) Short Form SF-12 v2
Timepoint [1] 1872 0
Assessed at baseline and every 4 weeks for a maximum of 6 months
Secondary outcome [1] 3295 0
Parental informational and emotional support
Timepoint [1] 3295 0
Assessed every 4 weeks
Secondary outcome [2] 3296 0
Parental perceived stress
Timepoint [2] 3296 0
Assessed every 4 weeks
Secondary outcome [3] 3297 0
Parent reported patient quality of life
Timepoint [3] 3297 0
Assessed every 4 weeks
Secondary outcome [4] 3298 0
Parent reported sibling quality of life
Timepoint [4] 3298 0
Assessed every 4 weeks
Secondary outcome [5] 3299 0
Health care utilisation
Timepoint [5] 3299 0
Assessed every 2 weeks
Secondary outcome [6] 3300 0
Family finacial costs
Timepoint [6] 3300 0
Assessed every 2 weeks
Secondary outcome [7] 3301 0
Parental satisfaction with care
Timepoint [7] 3301 0
Assessed week 5 and at bereavement.

Eligibility
Key inclusion criteria
Paediatric oncology patients aged 2-18 years from regional and remote areas requiring palliative care.
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)
NHMRC Clinical Trials Centre Randomisation Service
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
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
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1504 0
Charities/Societies/Foundations
Name [1] 1504 0
Royal Children's Hospital Foundation
Country [1] 1504 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] 1321 0
Hospital
Name [1] 1321 0
Oncology, Heamatology and Stem Cell Transplant Unit
Address [1] 1321 0
Royal Children's Hosptial, Brisbane
Herston QLD 4029
Country [1] 1321 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2925 0
Royal Children's Hospital Brisbane
Ethics committee address [1] 2925 0
Ethics committee country [1] 2925 0
Australia
Date submitted for ethics approval [1] 2925 0
Approval date [1] 2925 0
25/05/2005
Ethics approval number [1] 2925 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36327 0
Address 36327 0
Country 36327 0
Phone 36327 0
Fax 36327 0
Email 36327 0
Contact person for public queries
Name 10397 0
Mark Bensink
Address 10397 0
The University of Queensland Centre for Online Health Level 3 Foundation Building Royal Children's Hospital, Herston QLD 4029
Country 10397 0
Australia
Phone 10397 0
07 3346 4756
Fax 10397 0
07 3346 4705
Email 10397 0
[email protected]
Contact person for scientific queries
Name 1325 0
Mark Bensink
Address 1325 0
The University of Queensland Centre for Online Health Level 3 Foundation Building Royal Children's Hospital Herston QLD 4029
Country 1325 0
Australia
Phone 1325 0
07 3346 4756
Fax 1325 0
07 3346 4705
Email 1325 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.