Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000705684
Ethics application status
Approved
Date submitted
14/09/2005
Date registered
2/11/2005
Date last updated
2/11/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised phase III trial evaluating the efficacy of more intensive written information in patients having radical radiation therapy.
Scientific title
A prospective randomised phase III trial evaluating the effect of more intensive information on patient satisfaction and anxiety.
Universal Trial Number (UTN)
Trial acronym
P.S.S.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety levels 854 0
Patient satisfaction. 855 0
Condition category
Condition code
Mental Health 921 921 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is intensive written information and an extra nursing consultation.The written information outlines radiotherapy details and toxicity.Lifestyle issues such as diet,exercise,smoking and pratical issues such as parking and treatment costs.The control arm has a standard consultation.The intervention/control is for the duration of radiation treatment varying from 5-7 weeks.
Intervention code [1] 609 0
Lifestyle
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1206 0
The primary outcome is anxiety scores
Timepoint [1] 1206 0
Measured initially (prior to intervention) and following the intervention at 2 intervals (pre and post radiotherapy).
Secondary outcome [1] 2204 0
The secondary outcome is patient satisfaction.
Timepoint [1] 2204 0
This is measured following the intervention and prior to commencing radiotherapy.

Eligibility
Key inclusion criteria
The patient must be having radical radiotherapy.The patient must have a good understanding of english.The patient must be able to complete questionnaire unaided.Used only for patients diagnosed with Breast,Lung,Prostate,Rectal and Gynaecological cancer.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A poor understanding of written english.Significant visual impairment and previous radiation therapy.

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)
Both arms given information envelope.Numbered sealed envelopes where sequence was conceaed until interventions were assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number. Random allocation sequence is attended to by coin toss and blocking.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/06/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
212
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1016 0
Commercial sector/Industry
Name [1] 1016 0
Perth Radiation Oncology Centre
Country [1] 1016 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Perth Radiation Oncology Centre
Address
Country
Australia
Secondary sponsor category [1] 879 0
None
Name [1] 879 0
None
Address [1] 879 0
Country [1] 879 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2325 0
Royal Perth Hospital
Ethics committee address [1] 2325 0
Ethics committee country [1] 2325 0
Australia
Date submitted for ethics approval [1] 2325 0
Approval date [1] 2325 0
Ethics approval number [1] 2325 0

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

Contacts
Principal investigator
Name 35782 0
Address 35782 0
Country 35782 0
Phone 35782 0
Fax 35782 0
Email 35782 0
Contact person for public queries
Name 9798 0
Dr. Yvonne Zissiadis
Address 9798 0
Radiation Oncology Department
Royal Perth Hospital
Level II A Block
Wellington Street
Perth WA 6001
Country 9798 0
Australia
Phone 9798 0
+61 8 92242389
Fax 9798 0
+61 8 92241753
Email 9798 0
Yvonne.Zissiadis@health.wa.gov.au
Contact person for scientific queries
Name 726 0
Dr. Yvonne Zissiadis
Address 726 0
Radiation Oncology Department
Royal Perth Hospital
Level II A Block
Wellington Street
Perth WA 6001
Country 726 0
Australia
Phone 726 0
+61 8 92242389
Fax 726 0
+61 8 92241753
Email 726 0
Yvonne.Zissiadid@health.wa.gov.au

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.