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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 081986
ACTR Number: ACTRN12607000233426
Trial Status: Registered
Date Submitted: 27/04/2007
Date Registered: 3/05/2007

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Public title: ProsCan: Prostate cancer supportive care and patient outcomes project
ANZCTR registration title: ProsCan: A long term outcomes study involving a trial of a supportive care intervention to improve psychosocial outcomes in patients with Prostate Cancer.
Secondary ID: 
UTN:
Trial acronym: ProsCan

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Health condition(s) or problem(s) studied:
Prostate cancer 
Patterns of care 
Psychosocial and physical functioning outcomes; 
Genetics 
Treatment-decison making 
Economic Evaluation 
Condition category: Condition code:
Cancer Prostate 

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Description of intervention(s) / exposure: The support intervention is delivered by trained Prostate Care Nurses, and is designed to work with men from the time of diagnosis through to 5 months post-treatment, to assist men to manage the challenges associated with their diagnosis and treatment. The intervention focuses on treatment decision making, coping and stress management, and after treatment care related to treatment side-effects. The intervention is manualised and supported by a range of standard patient education materials and specifically developed resources. All participants receive a minimum of two intervention calls pre-treatment with the option for additional calls in instances where men are highly distressed or experiencing high uncertainty around treatment decision making. An additional two calls are made in the early post-treatment phase, with a booster at 5 months post-treatment.

Men who are ineligible to participate in the randomised controlled trial, but who are eligible to take part in the larger epidemiological study will receive usual care from their clinician and will be provided with the standard patient education materials currently available to prostate cancer patients.

Enrolment into the ProsCan study began in November 2004 with an anticipated final sample of approximately 1000 participants (including all pilot participants).

A pilot study of the intervention was undertaken between 1/11/04 and 31/8/05 with approximately 100 men newly diagnosed with localised prostate cancer. The main RCT of the intervention began on 1/9/05 and will involve approximately 650 men newly diagnosed with localised disease.
Intervention code:Other interventions 
Comparator / control treatment: The control group will receive usual care from their clinician and will be provided with the standard patient education materials currently available to prostate cancer patients.
Control group: Active

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Primary outcome:Efficacy of a telephone-based Support Intervention through improved psychosocial and physical functioning using the following measures: Decisional Conflict Scale; Decisional Regret Scale; Happiness Scale; Constructed Meaning Scale; Brief Distress Thermometer; Revised Impact of Events Scale; Short Form -36 (SF36 - Registered Trademark); Life Orientation Scale; International Prostate Symptom Score; Expanded Prostate Cancer Index Composite; Enhancing Recovery in Coronary Heart Disease (ENRICHD) Social Support Instrument; Satisfaction with Life Scale. 
Timepoint:Baseline, 2, 6, 12, 24, 36, 48 and 60 months post-treatment. 
Secondary outcome 1:To develop an Epidemiological description of medical characteristics and patterns of care for prostate cancer: Self-report survey of diagnostic pathways and patterns of care. 
Timepoint:Baseline 
Secondary outcome 2:To develop an Epidemiological description of medical characteristics and patterns of care for prostate cancer: Self-report survey of treatment pathways and patterns of care. 
Timepoint:Baseline, 2, 6, 12, 24, 36, 48 and 60 months post-treatment. 
Secondary outcome 3:To develop an Epidemiological description of medical characteristics and patterns of care for prostate cancer: Analysis of Medical Records. 
Timepoint:Data collected at 6 months post-treatment. 
Secondary outcome 4:To develop an Epidemiological description of medical characteristics and patterns of care for prostate cancer: Analysis of Cancer Registry records. 
Timepoint:Data collected at time of receipt of pathology in the Queensland Cancer Registry. 
Secondary outcome 5:Genetics of Prostate Cancer and relationship to clinical outcomes: Blood sample 
Timepoint:Blood sample taken before 3 years post-treatment 
Secondary outcome 6:Genetics of Prostate Cancer and relationship to clinical outcomes: Analysis of medical/clinical records. 
Timepoint:Data collected from records at 6 months post-treatment. 
Secondary outcome 7:Genetics of Prostate Cancer and relationship to clinical outcomes: Analysis of Cancer Registry records. 
Timepoint:Data collected from records at time of receipt of pathology in the Queensland Cancer Registry. 
Secondary outcome 8:Economic Evaluation of costs associated with Prostate Cancer: Medicare Australia data on all health-related and pharmaceutical costs. 
Timepoint:Data collected from Medicare Australia at approximately 2 years post-treatment. 
Secondary outcome 9:Economic Evaluation of costs associated with Postate Cancer: Self-report survey of health-related costs associated with prostate cancer 
Timepoint:2, 6, 12, and 24 months post-treatment. 
Secondary outcome 10:Economic Evaluation of costs associated with Intervention development, implementation and administration costs. 
Timepoint:November 2004 to December 2008. 

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Key inclusion criteria: First histological diagnosis of prostate cancer of any stage
Diagnosed in Queensland
Ability to give informed consent
English-speaking
Access to telephone.
Additional inclusion criteria for the intervention component of the ProsCan project: Diagnosis of localised prostate cancer
Minimum Age: 18 Years
Maximum Age: No limit
Gender: Males
Healthy volunteers? No
Key exclusion criteria: Cognitive impairment. Additional exclusion criteria for the intervention component of the ProsCan project: Locally advanced or metastatic prostate cancer Psychiatric illness Receiving active treatment for another cancer

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Study type: Interventional
Purpose of the study: Educational / counselling / training
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): Suitable participants will be identified by clinicians/hospital staff. After participants have provided informed consent baseline data will be collected. Eligibility for participation in the trial of the support intervention will then be determined. For eligible participants, allocation concealment will occur, with randomisation being undertaken by the holder of the allocation schedule who is based at the central administration site.
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): Simple randomisation using a computer generated table. Eligible participants will be stratified by age (less than or equal to 70 years versus greater than 70 years) and region (metropolitan versus regional).
Masking / blinding: Open (masking not used)
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Efficacy

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Phase
Anticipated or actual date of first participant enrolement: 1/11/2004
Target sample size: 1000
Recruitment status: Closed: follow-up continuing

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Funding source 1:Charities/Societies/Foundations 
Name:The Cancer Council Queensland 
Address:PO Box 201, Spring Hill Qld 4004 
Country:Australia 
Funding source 2:Government funding body e.g. Australian Research Council 
Name:National Health and Medical Research Council 
Address:GPO Box 1421 Canberra ACT 2601 
Country:Australia 
Funding source 3:University 
Name:Queensland University of Technology 
Address:Institute of Health and Biomedical Innovation Kelvin Grove Campus, Brisbane, Qld, 4059 
Country:Australia 
Primary sponsor: Charities/Societies/Foundations
Name: The Cancer Council Queensland
Address: PO Box 201, Spring Hill Qld 4004
Country: Australia
Secondary sponsor:University 
Name:Queensland University of Technology (QUT) 
Address:Institute of Health and Biomedical Innovation Kelvin Grove Campus, Brisbane, Qld, 4059 
Country:Australia 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name 1:Queensland University of Technology 
Address:Gardens Point Campus, Brisbane 
Country:Australia 
Date of approval:3/08/2004 
HREC Number:3629H 
Ethics Committee name 2:Royal Brisbane Hospital 
Address:Butterfield Street, Herston, Brisbane. 
Country:Australia 
Date of approval:21/02/2005 
HREC Number:2004/168 
Ethics Committee name 3:Princess Alexandra Hospital 
Address:Ipswich Road, Woolloongabba, Brisbane. 
Country:Australia 
Date of approval:15/02/2005 
HREC Number:2004/214 
Ethics Committee name 4:Mater Adults Hospital 
Address:Stanley Street, South Brisbane. 
Country:Australia 
Date of approval:21/07/2005 
HREC Number:794/A 
Ethics Committee name 5:Ipswich Hospital 
Address:Chelmsford Avenue, Ipswich. 
Country:Australia 
Date of approval:5/09/2005 
HREC Number:5/05 
Ethics Committee name 6:QEII Jubilee Hospital 
Address:Kessels Road, Coopers Plains, Brisbane. 
Country:Australia 
Date of approval:5/08/2005 
HREC Number: 
Ethics Committee name 7:Redcliffe Hospital 
Address:Anzac Avenue, Redciffe, Qld. 
Country:Australia 
Date of approval:12/04/2006 
HREC Number:06/Apr/10 
Ethics Committee name 8:Redlands Hospital 
Address:PO Box 585, Cleveland, Brisbane. 
Country:Australia 
Date of approval:19/08/2005 
HREC Number:64-08-2005 
Ethics Committee name 9:Greenslopes Private Hospital 
Address:Newdegate Street, Greenslopes, Brisbane. 
Country:Australia 
Date of approval:10/02/2005 
HREC Number:04/11 
Ethics Committee name 10:Townsville Hospital 
Address:PO Box 670, Townsville. 
Country:Australia 
Date of approval:9/03/2005 
HREC Number:68/04 
Ethics Committee name 11:Mackay Base Hospital 
Address:Bridge Road, Mackay. 
Country:Australia 
Date of approval:10/01/2006 
HREC Number:10/05 
Ethics Committee name 12:Queensland Cancer Registry Gazettal 
Address:Locked Bag 1450 Spring Hill Qld 4004 
Country:Australia 
Date of approval:29/04/2005 
HREC Number: 
Ethics Committee name 13:Medicare Australia 
Address:PO Box 1001, Tuggeranong, ACT, 2901 
Country:Australia 
Date of approval: 
HREC Number:2006/CO00441 
Countries of recruitment:Australia 
Brief summary: ProsCan will follow men with prostate cancer from the time of diagnosis to five years post-treatment to better understand their patterns of care and the resulting impact of diagnosis and treatment on their psychosocial, physical functioning and quality of life outcomes. In addition, the genetic biomarkers of prostate cancer will be investigated with particular emphasis on the relationship between biomarkers and clinical/medical outcomes. The project will evaluate whether there are subgroups of men who have better or worse outcomes based on the analysis of psychosocial and prognostic markers. Men with localised cancer will be offered the opportunity to participate in a randomised-controlled trial evaluating a telephone-based nurse-delivered, broad reach supportive care intervention. The intervention will provide support for treatment decision-making, managing the side effects of treatment, and stress management with the goal of improving quality of life. This is one of the first Australian large-scale longitudinal studies to track men with prostate cancer from the point of diagnosis and to follow them over time, and the first study internationally to assess this type of supportive care intervention.
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Ms Megan Ferguson
Address: The Cancer Council Queensland
PO Box 201
Spring Hill QLD 4004
Country: Australia
Tel: +61 7 32582356
Fax: +61 7 32582310
Email: MeganFerguson@cancerqld.org.au

Contact person for scientific queries
Name: Ms Megan Ferguson
Address: The Cancer Council Queensland
PO Box 201
Spring Hill QLD 4004
Country: Australia
Tel: +61 7 32582356
Fax: +61 7 32582310
Email: MeganFerguson@cancerqld.org.au

Contact person responsible for updating information
Name: Ms Megan Ferguson
Address: The Cancer Council Queensland PO Box 201 Spring Hill QLD 4004
Country: Australia
Tel: +61 7 32582356
Fax: +61 7 32582310
Email: MeganFerguson@cancerqld.org.au
   
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