Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000475943
Ethics application status
Approved
Date submitted
25/01/2011
Date registered
9/05/2011
Date last updated
21/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Radiation therapy, prostate cancer and follow-up: a feasibility study with primary care
Scientific title
A simple randomised clinical trial with an educational intervention to support general practitioners (GPs) to manage prostate cancer patients following radiation therapy.
Secondary ID [1] 252699 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer (radiation therapy side effects) 258187 0
Condition category
Condition code
Cancer 258366 258366 0 0
Prostate
Public Health 265873 265873 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This 12 month study involves an educational intervention whereby:
(a) GPs providing follow-up care to consenting patients may(group1) or may not ( group2) have access to an online education program. The education program being tested in this study is an online learning program. This educational program involves participants ( GPs) answering emailed case based questions which will be delivered to all practices via email. The Spaced Education program will focus on the management of patients following active treatment by a specialist, which may include surgery, radiotherapy and hormonal treatment. GPs will be sent 2 case studies with questions 2-3 times a week with 2-3 reminders. Questions will be repeated 14 days later if answered correctly and 21 days later if answered incorrectly. The program is completed when each question is answered correctly twice. The intervention developed for this feasibility study is expected to take only a few minutes every second day for approximately 6 weeks.
There will be no additional resources provided to the patients.
Intervention code [1] 257204 0
Diagnosis / Prognosis
Intervention code [2] 257208 0
Early detection / Screening
Intervention code [3] 257209 0
Treatment: Other
Comparator / control treatment
GPs allocated to group 2 do not have access to the educational program and patients are managed as per standard procedure. This means that the GPs are free to access existing prostate cancer guidelines if they deem this necessary to manage the patients.
Control group
Active

Outcomes
Primary outcome [1] 266651 0
Hospital Anxiety and Depression Scale (HADS).

Patients will be asked to complete the HADS. This scale contains 14 items; 7 items measure depression and 7 measure anxiety. It has established reliability and validity and is commonly used for cancer patients.
Timepoint [1] 266651 0
After each follow-up appointment with their GP for up to one year after recruitment.
Primary outcome [2] 266653 0
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30):
This questionnaire contains 30 items including functional scales (physical, role, emotional, social and cognitive functioning); symptom scales (measuring pain, fatigue and nausea and vomiting); an overall health status and quality of life scale; and other items measuring dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial impact. The psychometric properties of the scale have been validated in a range of different cancer types.

In addition the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-PR25) will be used.
This prostate-specific questionnaire is used in conjunction with EORTC QLQ-C30. It contains 25 items, including five scales: urinary symptoms, bother due to the use of incontinence aid, bowel symptoms, hormone treatment-related symptoms and sexual functioning. Studies support the psychometric robustness of this questionnaire.
Timepoint [2] 266653 0
After each follow-up appointment with their GP for up to one year after recruitment
Secondary outcome [1] 276145 0
Nil
Timepoint [1] 276145 0
Nil

Eligibility
Key inclusion criteria
To be eligible for inclusion, a patient must satisfy ALL of the following:
(a) Diagnosed with prostate cancer
(b) Completed curative radiation therapy for prostate cancer (patients can be up to 6 months post treatment at time of recruitment)
(c) Undergoing follow-up care
(d) Available for up to 12 months after recruitment
(e) Over 18 years of age
(f) Able to give informed consent.

To be eligible for inclusion, a GP must satisfy ALL of the following:
(a) their patient is eligible, consents and nominates them for the study
(b) Available for up to 12 months after recruitment
(c) Able to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if they are unable to provide informed consent.
GPs not available for 12 months of the study will not be included.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software. i.e. computerised sequence generation (http://www.random.org/integers/).
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
10/05/2011
Actual
18/05/2011
Date of last participant enrolment
Anticipated
Actual
13/08/2012
Date of last data collection
Anticipated
Actual
15/08/2013
Sample size
Target
240
Accrual to date
Final
195
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 257661 0
Government body
Name [1] 257661 0
Radiation Oncology Section of the Department of Health and Ageing: Cancer Australia
Country [1] 257661 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University
GPO Box U1987
PERTH WA 6845
Country
Australia
Secondary sponsor category [1] 256877 0
Hospital
Name [1] 256877 0
Sir Charles Gairdner Hospital
Address [1] 256877 0
Sir Charles Gairdner Hospital
Hospital Ave
NEDLANDS WA 6009
Country [1] 256877 0
Australia
Other collaborator category [1] 251519 0
Individual
Name [1] 251519 0
Dr Georgia Halkett
Address [1] 251519 0
Curtin University
Faculty of Health Sciences
School of Nursing, Midwifery & Paramedicine
GPO Box U1987
PERTH WA 6845
Country [1] 251519 0
Australia
Other collaborator category [2] 251520 0
Individual
Name [2] 251520 0
Prof. Moyez Jiwa
Address [2] 251520 0
University of Notre Dame Australia
Melbourne Clinical School
300 Princes Hwy
Werribee, Vic, 3030
Country [2] 251520 0
Australia
Other collaborator category [3] 251522 0
Individual
Name [3] 251522 0
Prof. Nigel Spry
Address [3] 251522 0
Radiation Oncology Department
Sir Charles Gairdner Hospital
Hospital Ave
NEDLANDS WA 6009
Country [3] 251522 0
Australia
Other collaborator category [4] 251523 0
Individual
Name [4] 251523 0
Prof. Afaf Girgis
Address [4] 251523 0
Centre for Health Research & Psycho-oncology (CHeRP)
University of Newcastle
Room 230A, Level 2, David Maddison Building
CALLAGHAN NSW 2308
Country [4] 251523 0
Australia
Other collaborator category [5] 251524 0
Individual
Name [5] 251524 0
A/Prof. Geoffrey Mitchell
Address [5] 251524 0
The University of Queensland
BRISBANE QLD 4072
Country [5] 251524 0
Australia
Other collaborator category [6] 251525 0
Individual
Name [6] 251525 0
Dr Moira O'Connor
Address [6] 251525 0
Curtin University
Faculty of Health Sciences
School of Psychology and Speech Pathology
GPO Box U1987
PERTH WA 6845
Country [6] 251525 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259678 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 259678 0
Ethics committee country [1] 259678 0
Australia
Date submitted for ethics approval [1] 259678 0
14/12/2010
Approval date [1] 259678 0
19/04/2011
Ethics approval number [1] 259678 0
HR 08/2011

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

Contacts
Principal investigator
Name 31647 0
A/Prof Georgia Halkett
Address 31647 0
Curtin University
Faculty of Health Sciences
School of Nursing, Midwifery & Paramedicine
GPO Box U1987
PERTH WA 6845
Country 31647 0
Australia
Phone 31647 0
+61 8 9266 1762
Fax 31647 0
Email 31647 0
[email protected]
Contact person for public queries
Name 14894 0
Georgia Halkett
Address 14894 0
Curtin University
Faculty of Health Sciences
School of Nursing, Midwifery & Paramedicine
GPO Box U1987
PERTH WA 6845
Country 14894 0
Australia
Phone 14894 0
+61 8 9266 1762
Fax 14894 0
Email 14894 0
[email protected]
Contact person for scientific queries
Name 5822 0
Georgia Halkett
Address 5822 0
Curtin University
Faculty of Health Sciences
School of Nursing, Midwifery & Paramedicine
GPO Box U1987
PERTH WA 6845
Country 5822 0
Australia
Phone 5822 0
+61 8 9266 1762
Fax 5822 0
Email 5822 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
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Documents added automatically
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