Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001137987
Ethics application status
Approved
Date submitted
31/10/2011
Date registered
31/10/2011
Date last updated
1/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early referral to palliative care: a randomised trial of patients with metastatic cancer and a survival expectation of less than 12 months
Scientific title
Early contact with palliative care services patients: a randomised trial of improvement in quality of life for newly detected incurable cancer patients with a survival expectation of less than 12 months.
Secondary ID [1] 273298 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic incurable cancer 279071 0
Condition category
Condition code
Cancer 279259 279259 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Contact with a palliative care (PC) nurse member of the hospital palliative care team who outines available palliative care services, offers to arrange review by a palliative care physician, and provides contact details. The PC nurse offers to telephone the patient monthly. The intervention continues during the lifespan of the patient.
Intervention code [1] 283645 0
Treatment: Other
Comparator / control treatment
Standard cancer care by the oncologist frequently involving chemotherapy with referral to palliative care services when needed
Control group
Active

Outcomes
Primary outcome [1] 279881 0
Quality of life monitored using the McGill quality of life (MQOL) questionnaire;
Timepoint [1] 279881 0
at baseline and monthly until death
Primary outcome [2] 279885 0
Rotterdam Symptom checklist;
Timepoint [2] 279885 0
at baseline and monthly until death;
Primary outcome [3] 279886 0
The degree of perceived support measured using the Supportive Care Needs - short form questionnaire (SCNS)
Timepoint [3] 279886 0
at baseline and every 4 months until death
Secondary outcome [1] 294671 0
Details of final hospital admission and context of death from
medical records
Timepoint [1] 294671 0
Time of death

Eligibility
Key inclusion criteria
Metastatic and incurable cancer with a life expectation of <12 months
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
previous contact with palliative care

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients with newly detected incurable cancer seeing an oncologist invited to join the study;
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software (i.e., computerised 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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 284129 0
Government body
Name [1] 284129 0
NHMRC Strategic Palliative Care Research Program
Country [1] 284129 0
Australia
Primary sponsor type
Individual
Name
Martin Henry Norman Tattersall
Address
Department of Cancer Medicine,
Blackburn Building, DO6,
University of Sydney,
NSW 2006
Country
Australia
Secondary sponsor category [1] 269090 0
None
Name [1] 269090 0
Address [1] 269090 0
Country [1] 269090 0
Other collaborator category [1] 252322 0
Government body
Name [1] 252322 0
Department of Palliative Care
Address [1] 252322 0
Royal Prince Alfred Hospital
Missenden Road,
Camperdown,
NSW 2050
Country [1] 252322 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272088 0
Central Sydney Area Health Service
Ethics committee address [1] 272088 0
Ethics committee country [1] 272088 0
Australia
Date submitted for ethics approval [1] 272088 0
Approval date [1] 272088 0
21/11/2001
Ethics approval number [1] 272088 0

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

Contacts
Principal investigator
Name 33332 0
Address 33332 0
Country 33332 0
Phone 33332 0
Fax 33332 0
Email 33332 0
Contact person for public queries
Name 16579 0
Martin HN Tattersall
Address 16579 0
Blackburn Building, DO 6,
University of Sydney,
NSW 2006
Country 16579 0
Australia
Phone 16579 0
61296607362
Fax 16579 0
61293514317
Email 16579 0
[email protected]
Contact person for scientific queries
Name 7507 0
Martin HN Tattersall
Address 7507 0
Blackburn Building, DO 6,
University of Sydney,
NSW 2006
Country 7507 0
Australia
Phone 7507 0
61296607362
Fax 7507 0
61293514317
Email 7507 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.