ANZCTR - Registration

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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]

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)

Condition category

Condition code

Cancer

Prostate

Public Health

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]

Diagnosis / Prognosis

Intervention code [2]

Early detection / Screening

Intervention code [3]

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]

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]

After each follow-up appointment with their GP for up to one year after recruitment.

Primary outcome [2]

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]

After each follow-up appointment with their GP for up to one year after recruitment

Secondary outcome [1]

Nil

Timepoint [1]

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?

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)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Radiation Oncology Section of the Department of Health and Ageing: Cancer Australia

Address [1]

Cancer Australia
PO Box 1201
DICKSON ACT 2602

Country [1]

Australia

Primary sponsor type

University

Name

Curtin University

Address

Curtin University
GPO Box U1987
PERTH WA 6845

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Sir Charles Gairdner Hospital

Address [1]

Sir Charles Gairdner Hospital
Hospital Ave
NEDLANDS WA 6009

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Dr Georgia Halkett

Address [1]

Curtin University
Faculty of Health Sciences
School of Nursing, Midwifery & Paramedicine
GPO Box U1987
PERTH WA 6845

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Prof. Moyez Jiwa

Address [2]

University of Notre Dame Australia
Melbourne Clinical School
300 Princes Hwy
Werribee, Vic, 3030

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Prof. Nigel Spry

Address [3]

Radiation Oncology Department
Sir Charles Gairdner Hospital
Hospital Ave
NEDLANDS WA 6009

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Prof. Afaf Girgis

Address [4]

Centre for Health Research & Psycho-oncology (CHeRP)
University of Newcastle
Room 230A, Level 2, David Maddison Building
CALLAGHAN NSW 2308

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

A/Prof. Geoffrey Mitchell

Address [5]

The University of Queensland
BRISBANE QLD 4072

Country [5]

Australia

Other collaborator category [6]

Individual

Name [6]

Dr Moira O'Connor

Address [6]

Curtin University
Faculty of Health Sciences
School of Psychology and Speech Pathology
GPO Box U1987
PERTH WA 6845

Country [6]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Research Ethics Committee

Ethics committee address [1]

GPO Box U1987 Perth
Western Australia 6845

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/12/2010

Approval date [1]

19/04/2011

Ethics approval number [1]

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

A/Prof Georgia Halkett

Address

Curtin University
Faculty of Health Sciences
School of Nursing, Midwifery & Paramedicine
GPO Box U1987
PERTH WA 6845

Country

Australia

Phone

+61 8 9266 1762

Fax

g.halkett@curtin.edu.au

Contact person for public queries

Name

Georgia Halkett

Address

Curtin University
Faculty of Health Sciences
School of Nursing, Midwifery & Paramedicine
GPO Box U1987
PERTH WA 6845

Country

Australia

Phone

+61 8 9266 1762

Fax

G.Halkett@curtin.edu.au

Contact person for scientific queries

Name

Georgia Halkett

Address

Curtin University
Faculty of Health Sciences
School of Nursing, Midwifery & Paramedicine
GPO Box U1987
PERTH WA 6845

Country

Australia

Phone

+61 8 9266 1762

Fax

G.Halkett@curtin.edu.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

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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