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Trial registered on ANZCTR


Registration number
ACTRN12607000233426
Ethics application status
Approved
Date submitted
27/04/2007
Date registered
3/05/2007
Date last updated
26/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
ProsCan: Prostate cancer supportive care and patient outcomes project
Scientific 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 [1] 283427 0
Nil
Universal Trial Number (UTN)
Trial acronym
ProsCan
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 1764 0
Patterns of care 1765 0
Psychosocial and physical functioning outcomes; 1766 0
Genetics 1767 0
Treatment-decison making 1768 0
Economic Evaluation 2314 0
Condition category
Condition code
Cancer 1856 1856 0 0
Prostate

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 1724 0
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

Outcomes
Primary outcome [1] 2600 0
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 [1] 2600 0
Baseline, 2, 6, 12, 24, 36, 48 and 60 months post-treatment.
Secondary outcome [1] 4459 0
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 [1] 4459 0
Baseline
Secondary outcome [2] 4460 0
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 [2] 4460 0
Baseline, 2, 6, 12, 24, 36, 48 and 60 months post-treatment.
Secondary outcome [3] 4461 0
To develop an Epidemiological description of medical characteristics and patterns of care for prostate cancer: Analysis of Medical Records.
Timepoint [3] 4461 0
Data collected at 6 months post-treatment.
Secondary outcome [4] 4462 0
To develop an Epidemiological description of medical characteristics and patterns of care for prostate cancer: Analysis of Cancer Registry records.
Timepoint [4] 4462 0
Data collected at time of receipt of pathology in the Queensland Cancer Registry.
Secondary outcome [5] 4463 0
Genetics of Prostate Cancer and relationship to clinical outcomes: Blood sample
Timepoint [5] 4463 0
Blood sample taken before 3 years post-treatment
Secondary outcome [6] 4464 0
Genetics of Prostate Cancer and relationship to clinical outcomes: Analysis of medical/clinical records.
Timepoint [6] 4464 0
Data collected from records at 6 months post-treatment.
Secondary outcome [7] 4465 0
Genetics of Prostate Cancer and relationship to clinical outcomes: Analysis of Cancer Registry records.
Timepoint [7] 4465 0
Data collected from records at time of receipt of pathology in the Queensland Cancer Registry.
Secondary outcome [8] 4466 0
Economic Evaluation of costs associated with Prostate Cancer: Medicare Australia data on all health-related and pharmaceutical costs.
Timepoint [8] 4466 0
Data collected from Medicare Australia at approximately 2 years post-treatment.
Secondary outcome [9] 4467 0
Economic Evaluation of costs associated with Postate Cancer: Self-report survey of health-related costs associated with prostate cancer
Timepoint [9] 4467 0
2, 6, 12, and 24 months post-treatment.
Secondary outcome [10] 4468 0
Economic Evaluation of costs associated with Intervention development, implementation and administration costs.
Timepoint [10] 4468 0
November 2004 to December 2008.

Eligibility
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
Sex
Males
Can healthy volunteers participate?
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

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)
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.
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)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2004
Actual
1/03/2005
Date of last participant enrolment
Anticipated
Actual
31/08/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
1074
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 2003 0
Charities/Societies/Foundations
Name [1] 2003 0
The Cancer Council Queensland
Country [1] 2003 0
Australia
Funding source category [2] 2004 0
Government body
Name [2] 2004 0
National Health and Medical Research Council
Country [2] 2004 0
Australia
Funding source category [3] 2005 0
University
Name [3] 2005 0
Queensland University of Technology
Country [3] 2005 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Cancer Council Queensland
Address
PO Box 201, Spring Hill Qld 4004
Country
Australia
Secondary sponsor category [1] 1816 0
University
Name [1] 1816 0
Queensland University of Technology (QUT)
Address [1] 1816 0
Institute of Health and Biomedical Innovation
Kelvin Grove Campus, Brisbane, Qld, 4059
Country [1] 1816 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3713 0
Queensland University of Technology
Ethics committee address [1] 3713 0
Gardens Point Campus, Brisbane
Ethics committee country [1] 3713 0
Australia
Date submitted for ethics approval [1] 3713 0
Approval date [1] 3713 0
03/08/2004
Ethics approval number [1] 3713 0
3629H
Ethics committee name [2] 3714 0
Royal Brisbane Hospital
Ethics committee address [2] 3714 0
Butterfield Street, Herston, Brisbane.
Ethics committee country [2] 3714 0
Australia
Date submitted for ethics approval [2] 3714 0
Approval date [2] 3714 0
21/02/2005
Ethics approval number [2] 3714 0
2004/168
Ethics committee name [3] 3715 0
Princess Alexandra Hospital
Ethics committee address [3] 3715 0
Ipswich Road, Woolloongabba, Brisbane.
Ethics committee country [3] 3715 0
Australia
Date submitted for ethics approval [3] 3715 0
Approval date [3] 3715 0
15/02/2005
Ethics approval number [3] 3715 0
2004/214
Ethics committee name [4] 3716 0
Mater Adults Hospital
Ethics committee address [4] 3716 0
Stanley Street, South Brisbane.
Ethics committee country [4] 3716 0
Australia
Date submitted for ethics approval [4] 3716 0
Approval date [4] 3716 0
21/07/2005
Ethics approval number [4] 3716 0
794/A
Ethics committee name [5] 3717 0
Ipswich Hospital
Ethics committee address [5] 3717 0
Chelmsford Avenue, Ipswich.
Ethics committee country [5] 3717 0
Australia
Date submitted for ethics approval [5] 3717 0
Approval date [5] 3717 0
05/09/2005
Ethics approval number [5] 3717 0
5/05
Ethics committee name [6] 3718 0
QEII Jubilee Hospital
Ethics committee address [6] 3718 0
Kessels Road, Coopers Plains, Brisbane.
Ethics committee country [6] 3718 0
Australia
Date submitted for ethics approval [6] 3718 0
Approval date [6] 3718 0
05/08/2005
Ethics approval number [6] 3718 0
Ethics committee name [7] 3719 0
Redcliffe Hospital
Ethics committee address [7] 3719 0
Anzac Avenue, Redciffe, Qld.
Ethics committee country [7] 3719 0
Australia
Date submitted for ethics approval [7] 3719 0
Approval date [7] 3719 0
12/04/2006
Ethics approval number [7] 3719 0
06/Apr/10
Ethics committee name [8] 3720 0
Redlands Hospital
Ethics committee address [8] 3720 0
PO Box 585, Cleveland, Brisbane.
Ethics committee country [8] 3720 0
Australia
Date submitted for ethics approval [8] 3720 0
Approval date [8] 3720 0
19/08/2005
Ethics approval number [8] 3720 0
64-08-2005
Ethics committee name [9] 3721 0
Greenslopes Private Hospital
Ethics committee address [9] 3721 0
Newdegate Street, Greenslopes, Brisbane.
Ethics committee country [9] 3721 0
Australia
Date submitted for ethics approval [9] 3721 0
Approval date [9] 3721 0
10/02/2005
Ethics approval number [9] 3721 0
04/11
Ethics committee name [10] 3722 0
Townsville Hospital
Ethics committee address [10] 3722 0
PO Box 670, Townsville.
Ethics committee country [10] 3722 0
Australia
Date submitted for ethics approval [10] 3722 0
Approval date [10] 3722 0
09/03/2005
Ethics approval number [10] 3722 0
68/04
Ethics committee name [11] 3723 0
Mackay Base Hospital
Ethics committee address [11] 3723 0
Bridge Road, Mackay.
Ethics committee country [11] 3723 0
Australia
Date submitted for ethics approval [11] 3723 0
Approval date [11] 3723 0
10/01/2006
Ethics approval number [11] 3723 0
10/05
Ethics committee name [12] 3724 0
Queensland Cancer Registry Gazettal
Ethics committee address [12] 3724 0
Locked Bag 1450
Spring Hill Qld 4004
Ethics committee country [12] 3724 0
Australia
Date submitted for ethics approval [12] 3724 0
Approval date [12] 3724 0
29/04/2005
Ethics approval number [12] 3724 0
Ethics committee name [13] 3725 0
Medicare Australia
Ethics committee address [13] 3725 0
PO Box 1001, Tuggeranong, ACT, 2901
Ethics committee country [13] 3725 0
Australia
Date submitted for ethics approval [13] 3725 0
Approval date [13] 3725 0
Ethics approval number [13] 3725 0
2006/CO00441

Summary
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
Trial related presentations / publications
Chambers SK, Ferguson M, Gardiner RA, Nicol D, Gordon L, Occhipinti S, Aitken J. ProsCan for men: randomised controlled trial of a decision support intervention for men with localised prostate cancer. BMC Cancer 2008; 8: 207.

Chambers SK, Ferguson M, Gardiner RA, Aitken J, Occhipinti S. Intervening to improve psychological outcomes for men with prostate cancer. Psychooncology 2013; 22: 1025-1034.

Amin Al Olama A, Benlloch S, Antoniou AC, Giles GG, Severi G, Neal D, Hamdy FC, Donovan JL, Muir K, Schleutker J, Henderson BE, Haiman C, Schumacher FR, Pashayan N, Pharoah PD, Ostrander EA, Stanford JL, Batra J, Clements JA, Chambers SK, Weischer M, Nordestgaard BG, Ingles SA, Sorensen KD, Orntoft TF, Park JY, Cybulski C, Maier C, Doerk T, Dickinson JL, Cannon-Albright L, Brenner H, Rebbeck TR, Zeigler-Johnson C, Habuchi T, Thibodeau SN, Cooney K, Chappuis PO, Hutter P, Kaneva RP, Foulkes WD, Zeegers MP, Lu YJ, Zhang HW, Stephenson R, Cox A, Southey MC, Spurdle AB, FitzGerald L, Leongamornlert D, Saunders E, Tymrakiewicz M, Guy M, Dadaev T, Little SJ, Govindasami K, Sawyer E, Wilkinson R, Herkommer K, Hopper JL, Lophatonanon A, Rinckleb AE, Kote-Jarai Z, Eeles RA, Easton DF. Risk Analysis of Prostate Cancer in PRACTICAL, a Multinational Consortium, Using 25 Known Prostate Cancer Susceptibility Loci. Cancer Epidemiol Biomarkers Prev 2015; 24: 1121-1129.

Alexander KE, Chambers S, Spurdle AB, Batra J, Lose F, O'Mara TA, Gardiner RA, Aitken JF, Clements JA, Kedda MA, Janda M. Association between single-nucleotide polymorphisms in growth factor genes and quality of life in men with prostate cancer and the general population. Qual Life Res 2015; 24: 2183-2193.

Lose F, Batra J, O'Mara T, Fahey P, Marquart L, Eeles RA, Easton DF, Al Olama AA, Kote-Jarai Z, Guy M, Muir K, Lophatananon A, Rahman AA, Neal DE, Hamdy FC, Donovan JL, Chambers S, Gardiner RA, Aitken JF, Yaxley J, Alexander K, Clements JA, Spurdle AB, Kedda MA. Common variation in Kallikrein genes KLK5, KLK6, KLK12, and KLK13 and risk of prostate cancer and tumor aggressiveness. Urologic oncology 2013; 31: 635-643.

Amin Al Olama A, Kote-Jarai Z, Schumacher FR, Wiklund F, Berndt SI, Benlloch S, Giles GG, Severi G, Neal DE, Hamdy FC, Donovan JL, Hunter DJ, Henderson BE, Thun MJ, Gaziano M, Giovannucci EL, Siddiq A, Travis RC, Cox DG, Canzian F, Riboli E, Key TJ, Andriole G, Albanes D, Hayes RB, Schleutker J, Auvinen A, Tammela TL, Weischer M, Stanford JL, Ostrander EA, Cybulski C, Lubinski J, Thibodeau SN, Schaid DJ, Sorensen KD, Batra J, Clements JA, Chambers S, Aitken J, Gardiner RA, et al. A meta-analysis of genome-wide association studies to identify prostate cancer susceptibility loci associated with aggressive and non-aggressive disease. Human molecular genetics 2013; 22: 408-415.

Lose F, Lawrence MG, Srinivasan S, O’Mara T, Marquart L, Chambers S, Gardiner RA, Aitken JF, Spurdle AB, Batra J, Clements JA, and the Australian Prostate Cancer BioResource. The kallikrein 14 gene is down-regulated by androgen receptor signalling and harbours genetic variation that is associated with prostate tumour aggressiveness. Biol Chem 2012; 393:403-412.

Lose F, Srinivasan S, O'Mara T, Marquart L, Chambers S, Gardiner RA, Aitken JF; the Australian Prostate Cancer BioResource, Spurdle AB, Batra J, Clements JA. Genetic association of the KLK4 Locus with Risk of Prostate Cancer.  PLoS ONE 2012; 7(9):e44520.  

Kote-Jarai Z, Olama AA, Giles GG, Severi G, Schleutker J, Weischer M, Campa D, Riboli E, Key T, Gronberg H, Hunter DJ, Kraft P, Thun MJ, Ingles S, Chanock S, Albanes D, Hayes RB, Neal DE, Hamdy FC, Donovan JL, Pharoah P, Schumacher F, Henderson BE, Stanford JL, Ostrander EA, Sorensen KD, Dork T, Andriole G, Dickinson JL, Cybulski C, Lubinski J, Spurdle A, Clements JA, Chambers S, Aitken J, Gardiner RA, et al. Seven prostate cancer susceptibility loci identified by a multi-stage genome-wide association study. Nat Genet 2011; 43:785-791.

Batra J, Lose F, O’Mara T, Marquart L, Stephens C, Alexander K, Srinivasan S, Eeles RA, Easton DF, Amin Al Olama A, Kote-Jarai Z, Guy M, Muir K, Lophatananon A, Rahman AA, Neal DE, Hamdy FC, Donovan JL, Chambers SK, Gardiner RA, Aitken J, Yaxley J, Kedda, M-A, Clements JA, Spurdle AB. Association between Prostinogen (KLK15) genetic variants and prostate cancer risk and aggressiveness in Australia and a Meta-analysis of GWAS data. PLoS ONE 2011; 6:e26527.

Eeles RA, Kote-Jarai Z, Al Olama AA, Giles GG, Guy M, Severi G, Muir K, Hopper JL, Henderson BE, Haiman CA, Schleutker J, Hamdy FC, Neal DE, Donovan JL, Stanford JL, Ostrander EA, Ingles SA, John EM, Thibodeau SN, Schaid D, Park JY, Spurdle A, Clements J, Dickinson JL, Maier C, Vogel W, Dork T, Rebbeck TR, Cooney KA, Cannon-Albright L, Chappuis PO, Hutter P, Zeegers M, Kaneva R, Zhang HW, Lu YJ, Foulkes WD, English DR, Leongamornlert DA, Tymrakiewicz M, Morrison J, Ardern-Jones AT, Hall AL, O'Brien LT, Wilkinson RA, Saunders EJ, Page EC, Sawyer EJ, Edwards SM, Dearnaley DP, Horwich A, Huddart RA, Khoo VS, Parker CC, Van As N, Woodhouse CJ, Thompson A, Christmas T, Ogden C, Cooper CS, Southey MC, Lophatananon A, Liu JF, Kolonel LN, Le Marchand L, Wahlfors T, Tammela TL, Auvinen A, Lewis SJ, Cox A, FitzGerald LM, Koopmeiners JS, Karyadi DM, Kwon EM, Stern MC, Corral R, Joshi AD, Shahabi A, McDonnell SK, Sellers TA, Pow-Sang J, Chambers S, Aitken J, Gardiner RA, Batra J, Kedda MA, Lose F, Polanowski A, Patterson B, Serth J, Meyer A, Luedeke M, Stefflova K, Ray AM, Lange EM, Farnham J, Khan H, Slavov C, Mitkova A, Cao G, Easton DF. Identification of seven new prostate cancer susceptibility loci through a genome-wide association study. Nature genetics 2009; 41: 1116-1121.

Kote-Jarai Z, Easton DF, Stanford JL, Ostrander EA, Schleutker J, Ingles SA, Schaid D, Thibodeau S, Dork T, Neal D, Donovan J, Hamdy F, Cox A, Maier C, Vogel W, Guy M, Muir K, Lophatananon A, Kedda MA, Spurdle A, Steginga S, John EM, Giles G, Hopper J, Chappuis PO, Hutter P, Foulkes WD, Hamel N, Salinas CA, Koopmeiners JS, Karyadi DM, Johanneson B, Wahlfors T, Tammela TL, Stern MC, Corral R, McDonnell SK, Schurmann P, Meyer A, Kuefer R, Leongamornlert DA, Tymrakiewicz M, Liu JF, O'Mara T, Gardiner RA, Aitken J, Joshi AD, Severi G, English DR, Southey M, Edwards SM, Al Olama AA, Eeles RA. Multiple novel prostate cancer predisposition loci confirmed by an international study: the PRACTICAL Consortium. Cancer Epidemiol Biomarkers Prev 2008; 17: 2052-2061.

Baade PD, Aitken JF, Ferguson M, Gardiner RA, Chambers SK. Diagnostic and treatment pathways for men with prostate cancer in Queensland: investigating spatial and demographic inequalities. BMC Cancer 2010; 10:452.

Baade PD, Youlden DR, Coory M, Gardner RA, Chambers SK.  Urban rural differences in prostate cancer outcomes in Australia – what has changed? MJA 2011; 194(6): 293-296.

Baade PD, Gardiner RA, Ferguson M, Youlden DR, Aitken JF, Yaxley J, Chambers SK. Factors associated with diagnostic and treatment intervals for prostate cancer in Queensland, Australia: a large cohort study. Cancer Causes Control 2012; 23: 625-634.

Baade PD, Youlden DR, Gardiner RA, Ferguson M, Aitken JF, Yaxley J, Chambers SK. Factors associated with treatment received by men diagnosed with prostate cancer in Queensland, Australia. BJU Int 2012; 110: E712-719.
Public notes

Contacts
Principal investigator
Name 27827 0
Prof Joanne Aitken
Address 27827 0
Cancer Council Queensland
PO Box 201
Spring Hill QLD 4004
Country 27827 0
Australia
Phone 27827 0
+ 61 7 3634 5300
Fax 27827 0
+61 7 3259 8527
Email 27827 0
[email protected]
Contact person for public queries
Name 10913 0
Lisa Nielsen
Address 10913 0
Cancer Council Queensland
PO Box 201
Spring Hill QLD 4004
Country 10913 0
Australia
Phone 10913 0
+61 7 3634 5393
Fax 10913 0
+61 7 3259 8527
Email 10913 0
[email protected]
Contact person for scientific queries
Name 1841 0
Lisa Nielsen
Address 1841 0
Cancer Council Queensland
PO Box 201
Spring Hill QLD 4004
Country 1841 0
Australia
Phone 1841 0
+61 7 3634 5393
Fax 1841 0
+61 7 3259 8527
Email 1841 0
[email protected]

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