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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
GPO Box U1987 Perth
Western Australia 6845
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
The prevalence of cancer detected at an early stage of the disease is rising, which means that more people require adjuvant cancer treatment and are surviving for longer periods of time. As a result, cancer specialists are faced with large numbers of patients who not only require treatment but also long term follow-up care. In Australia, radiation oncology clinics are heavily subscribed and patients’ appointments are subject to waiting lists. This situation would be improved if patients who have completed their treatment could be discharged to the care of their GP. It is anticipated that routine follow-up with a specialist will not be possible in the future and alternative safe and effective strategies for follow-up need to be developed.

Prostate cancer is the most common cancer in Australian men. Although prostate cancer is life threatening, the majority of patients who present with early disease live beyond five years. While treatment increases survival rates, a myriad of associated physical side effects may have an impact on the patient’s quality of life. Common side effects of radiation therapy include: loss of sexual potency, erectile dysfunction, loss of libido, urinary tract symptoms, incontinence and proctitis. If prostate cancer is not treated early patients are also at risk of disease spread. Following radiation therapy patients therefore need to be monitored for both side effects and disease spread. The provision of follow-up care for prostate cancer is under-researched.

GPs are well placed to take on the role of providing follow-up care for patients who have previously been treated in specialist clinics. However, previous studies report that GPs have varying knowledge of the use of radiation therapy and consequently have limited expertise in managing side effects and providing appropriate referral. Innovative educational resources therefore need to be developed to assist GPs in advising patients who have received radiation therapy.

Hypothesis:
The evidence based resources (GP educational program) will assist GPs in providing follow-up care to patients and increase patient enablement. If GPs are able to take on this role in the multidisciplinary team, other patients will be able to access radiation oncology sooner and radiation oncology will be able to provide rapid access to patients who require urgent treatment or care.
Trial website
Trial related presentations / publications
Jiwa M. Re-inventing the doctor. Presentation at Primary Care and Prevention Collaborative
Meeting, WA Cancer and Palliative Care Network and Curtin Health Innovation Research
Institute. Videos now available at: http://www.youtube.com/watch?v=Mlq-
H2sjrgg&feature=list_related&playnext=1&list=SP71487FD30B09285A and
http://www.youtube.com/watch?v=W0Pkwu6NZ7o&feature=relmfu

Jiwa, M., Halkett, G., Meng, X, Pillai, V., Berg, M.; and Shaw, T. Supporting Patients Treated for
Prostate Cancer: A Video Vignette Study With an Email-Based Educational Program in General Practice. Journal of Medical Internet Research 2014; 16 (2): e63.

Jiwa, M., Halkett, G., Meng, X, Pillai, V., Berg, M. Rating general practitioner consultation performance in cancer care: Does the specialty of assessors matter? A simulated patient study. BMC Family Practice 2014: 15(1):152

Jiwa, M. Supporting patients treated for prostate cancer- a video vignette study with an email based educational program in general practice. GP14 – The Royal Australian College of General Practitioners Conference for General Practice, 9 – 11 October 2014, Adelaide,
Australia.
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]

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