Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000361202
Ethics application status
Approved
Date submitted
20/04/2009
Date registered
26/05/2009
Date last updated
26/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study of Changes in Quality of Life as a Measure of Interventions in Patients with Cancer
Scientific title
A randomized study of intercessory prayer to improve the spiritual well being and quality of life of patients being treated for cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spiritual Wellbeing in patients being treated for cancer 4633 0
Condition category
Condition code
Cancer 4935 4935 0 0
Other cancer types
Alternative and Complementary Medicine 237117 237117 0 0
Spiritual care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intercessory Prayer of unspecified duration to be determined by prayers usually daily over a 6 months period. They complete qualiry of life and spirtiual wellbeing scales at entry then 6 months later.
Intervention code [1] 4393 0
Other interventions
Comparator / control treatment
Observation by completing quality of life and spiritual wellbeing scales without an intervention
Control group
Active

Outcomes
Primary outcome [1] 5781 0
Change in spiritual wellbeing score on Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp) scale
Timepoint [1] 5781 0
6 months after entering the trial and completing the initial quality of life and spiritual wellbeing measures
Secondary outcome [1] 241755 0
Quality of Life as measured by the Functional Assessment of Chronic Illness Therapy- General and the Mental Adjustment to Cancer scales
Timepoint [1] 241755 0
6 months after the intervention commenced

Eligibility
Key inclusion criteria
cancer diagnosis, age over 18 years, the ability to read English, ability to consent, having a prognosis of greater than 6 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to complete questionnaires in English
Prognosis less than 6 months

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)
Consecutive new patients with cancer presenting to the Cancer Centre and treatment alllocated by random sequence. Allocation involved contacting the the holder of the allocation schedule who was at a central administration site and not responsible for determining the eligibility of a subject
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pre existing random sequence generated and given to independent data management team
Masking / blinding
Blinded (masking 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
20/06/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4815 0
Hospital
Name [1] 4815 0
Royal Adelaide Hospital
Country [1] 4815 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 4347 0
None
Name [1] 4347 0
Address [1] 4347 0
Country [1] 4347 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6863 0
Royal Adelaide Hosptial Ethics Committee
Ethics committee address [1] 6863 0
Ethics committee country [1] 6863 0
Australia
Date submitted for ethics approval [1] 6863 0
Approval date [1] 6863 0
01/05/2003
Ethics approval number [1] 6863 0
030326

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

Contacts
Principal investigator
Name 29512 0
Address 29512 0
Country 29512 0
Phone 29512 0
Fax 29512 0
Email 29512 0
Contact person for public queries
Name 12759 0
Ian Olver
Address 12759 0
Cancer Council Australia
120 Chalmers Street, Surrry Hills
NSW 2010
Country 12759 0
Australia
Phone 12759 0
+61280634100
Fax 12759 0
+61280634102
Email 12759 0
[email protected]
Contact person for scientific queries
Name 3687 0
Ian Olver
Address 3687 0
Cancer Council Australia
120 Chalmers Street
Surry Hills NSW 2010
Country 3687 0
Australia
Phone 3687 0
+61280634100
Fax 3687 0
+61280634102
Email 3687 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.