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Trial registered on ANZCTR


Registration number
ACTRN12606000184572
Ethics application status
Approved
Date submitted
16/05/2006
Date registered
17/05/2006
Date last updated
24/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Meeting the Needs of Men with Prostate Cancer Using a Consumer-Driven Multidisciplinary Approach
Scientific title
The effect of a nurse-led, group psychoeducational intervention to reduce psychological morbidity, unmet needs and improve quality of life of men receiving radiotherapy for prostate cancer.
Secondary ID [1] 286255 0
Nil
Universal Trial Number (UTN)
Trial acronym
PCRCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 1157 0
Condition category
Condition code
Cancer 1241 1241 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention comprises four, 1-hour group psychoeducational consultations led by a clinical nurse consultant, and one individualised nurse session usually in the first week of treatment (15 - 30mins). The consultations occur at critical moments in the illness trajectory: pre-treatment, mid-treatment, end of treatment and 6 weeks post-treatment. The focus of these sessions are to share common concerns, ask questions and receive information. The content of sessions are tailored to patient concerns.
Intervention code [1] 1045 0
Other interventions
Comparator / control treatment
The control group will receive standard care.
Control group
Active

Outcomes
Primary outcome [1] 1676 0
Depression and anxiety at follow up, measured by the Hospital Anxiety and Depression Scale (HADS).
Timepoint [1] 1676 0
Questionnaires administered at baseline (pre-treatment), treatment completion and 6-months post-treatment.
Secondary outcome [1] 3006 0
Prostate cancer specific quality of life (EPIC-26).
Timepoint [1] 3006 0
Questionnaires administered pre-treatment, end and 6 months post treatment.
Secondary outcome [2] 3007 0
Unmet supportive care needs (SCNS-SF).
Timepoint [2] 3007 0
Questionnaires administered pre-treatment, end and 6 months post treatment.
Secondary outcome [3] 313193 0
Cancer treatment related concerns (CATS).
Timepoint [3] 313193 0
End of treatment.
Secondary outcome [4] 313194 0
Global distress (DT).
Timepoint [4] 313194 0
Questionnaires administered pre-treatment, end and 6 months post treatment.

Eligibility
Key inclusion criteria
1) has a confirmed diagnosis of prostate cancer; 2) is being treated with curative intent as determined by their treating doctor; 3) scheduled to receive or undergoing radiotherapy; 4) over 18 years; 5) agrees to attend 4 group consultations; 6) is able to understand English.
Minimum age
18 Years
Maximum age
Not stated
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1) has cognitive or psychological difficulties; 2) is too sick; 3) has had previous radiotherapy treatment; 4) is being treated palliatively; or 5) is having seed brachytherapy alone.

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)
A trained research assistant (RA) will screen clinic lists, attend the weekly urology meeting and liaise with clinical staff to identify eligible patients, using an eligibility checklist. The RA will meet with eligible patients after their consultation with their doctor and seek informed written consent. Consenters will be asked permission to collect basic demographic and clinical information from their medical records. Reasons for refusal will be obtained. After consenting, patients complete the baseline questionnaire. The RA can then inform the patient of group allocation. Group allocation was concealed with central computer-generated randomisation occuring at the end of the recruitment fortnight. Recruitment procedures will adhere to CONSORT criteria and will be documented in a recruitment manual to enable recruitment to continue if the RA is absent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The cluster randomisation by fortnight was guided by outcomes of the pilot study and selected to ensure sufficient patients were recruited at each site to form a single group that could then receive the intervention package (3 or more men) at a similar stage in the treatment trajectory. To reduce potential bias during each fortnight, the result of randomisation will only be revealed to research staff, clinic staff and participants at the end of the fortnight period, and after baseline data collection is complete. The method of randomisation will be by a weighted-biased coin method for each fortnightly group at each site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster randomised controlled trial.
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3513 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [2] 3514 0
Monash Medical Centre - Moorabbin campus - East Bentleigh

Funding & Sponsors
Funding source category [1] 1357 0
Charities/Societies/Foundations
Name [1] 1357 0
Cancer Council Victoria
Address [1] 1357 0
615 St Kilda Rd
Melbourne VIC 3000
Country [1] 1357 0
Australia
Funding source category [2] 290816 0
Government body
Name [2] 290816 0
National Health and Medical Research Council
Address [2] 290816 0
Level 1, 16 Marcus Clarke Street
Canberra ACT 2601
Country [2] 290816 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Peter MacCallum Cancer Centre
Address
St Andrews Pl
East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 1198 0
None
Name [1] 1198 0
Nil
Address [1] 1198 0
Country [1] 1198 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2714 0
Human Research Ethics Committee at Peter MacCallum Cancer Centre
Ethics committee address [1] 2714 0
Ethics committee country [1] 2714 0
Australia
Date submitted for ethics approval [1] 2714 0
Approval date [1] 2714 0
06/06/2006
Ethics approval number [1] 2714 0
06/21

Summary
Brief summary
Prostate cancer is the most common serious cancer in Australian men. Radiotherapy is a common treatment for prostate cancer, which can result in distressing side effects, including urinary and bowel urgency or incontinence (35%), and erectile dysfunction (41% to 55%). These are complex and often chronic conditions, which can adversely affect the patient's quality of life and psychological morbidity. Men with prostate cancer also experience high unmet needs, particularly in relation to sexuality.
This research aims to examine the effectiveness of a multi-disciplinary care (MDC) program incorporating consumer involvement to reduce psychological morbidity, unmet needs and improve quality of life in men receiving radiotherapy for prostate cancer using a randomised controlled trial (RCT). 400 men will be recruited and complete baseline measures before being randomised to receive the psycho-educational intervention or usual care. The intervention will comprise of four, 1-hour group consultations led by a clinical nurse consultant, and one individualised nurse session. The consultations occur at critical moments in the illness trajectory: pre-treatment, mid-treatment, end of treatment and 6 weeks post-treatment. The focus of these sessions will be to share common concerns, ask questions and receive information. The content of sessions are tailored to patient concerns.
Follow up questionnaires will be administered at the end of treatment, and 6 months post-treatment. The program will be evaluated by comparing results for the control and intervention groups on measures for anxiety and depression, unmet needs, quality of life, distress and preparation for cancer treatment.
Trial website
Trial related presentations / publications
Journal Articles
1. Kathryn Schubach, Ann Boonzaier, Kathy Troup, Mariko Carey, Sanchia Aranda and Penelope Schofield (2007). Improving outcomes for men, Australian Nursing Journal, 15 (1), 35. ISSN: ISSN: 1320-3185
2. W Crellin, K Schubach (2008). A consumer’s journey through a prostate cancer research project, Aust Nurs J, 15 (11), 55-56.
3. A Boonzaier, K Schubach, S Aranda & P Schofield (2009). Development of a Psycho-educational Intervention for Men with Prostate Cancer, J. Psychosocial Oncol, 27(1) 136-153.
4. M Carey, R Sanson-Fisher, K Lotfi-Jam, P Schofield, S Aranda (2010). Multidisciplinary care in cancer: Do the current research outputs help? European Journal of Cancer Care, 19 (4): 434-41.
5. K Sharkey, J Savulescu, S Aranda, P Schofield (2010). Clinician gate-keeping in clinical research is not ethically defensible: an analysis. J Med Ethics, 36 (6): 363-366.
6. Penelope Schofield, Karla Gough, Kerryann Lotfi-Jam Sanchia Aranda, Validation of the Supportive Care Needs Survey-Short Form 34 (SCNS-SF34) with a simplified response format in men with prostate cancer, Under review at Psycho-Oncology, 2011. Doi: 10.1002/pon.2016. [Epub ahead of print]
7. W Crellin (2012). Is frequent urination a symptom of prostate cancer? A consumer’s perspective. Health Issues, Winter 2012: 16. ISSN: 0819-5781
8. Kerryann Lotfi-Jam, Karla Gough, Penelope Schofield,Sanchia Aranda, Profile and predictors of global distress: can the DT guide nursing practice in prostate cancer? Accepted in Palliative & Supportive Care, January 2013.


Conference Presentations
1. M Carey, et al. (oral presentation) Development of a multidisciplinary care intervention to improve psychosocial outcomes for men with prostate cancer. AGM of the Australian Prostate Cancer Collaboration, Sydney Oct 4th, 2006.
2. K Wyatt, et al. (poster presentation) Development of a multidisciplinary care intervention to improve psychosocial outcomes for men with prostate cancer. Clinical Oncology Society of Australia ASM, Melbourne 2006. = published abstract.
3. W Crellin and K Schubach (oral presentation) A consumer’s journey through a prostate cancer research project. WCMICS Supportive Care Conference, Melbourne, 17th October 2008.
4. K Schubach. (oral presentation) From urology nurse to research my involvement in a large randomised controlled trial. Accepted Urological Society of Australia and New Zealand ASM, Gold Coast, March 2009. = published abstract.
5. K Lotfi-Jam, et al (oral presentation) Unmet needs, psychological distress and quality of life in men commencing radiotherapy for prostate cancer. 12th World Congress of Psycho-Oncology (IPOS), Quebec, May 2010. = published abstract.
6. K Lotfi-Jam, et al (poster presentation) Unmet needs, psychological distress and quality of life in men commencing radiotherapy for prostate cancer. Clinical Oncological Society of Australia, Melbourne, Nov 2010. = published abstract.
7. W Crellin, K Schubach: Fore-warned is fore-armed: Supportive care for prostate cancer patients receiving curative radiotherapy. Presented orally at Australasian Heath and Research Data Manager’s Association, Melbourne, March 2011.
8. W Crellin, K Schubach: ‘Involving consumers in research: Fore-warned is fore-armed - Supportive care for men with prostate cancer’, The Victorian Healthcare Quality Association and the Centre for Research Excellence in Patient Safety Professional Development Session, Alfred Hospital, Melbourne, Australia 16th May 2011.
9. P. Schofield, et al (oral presentation) Unmet needs, psychological distress and quality of life in men commencing radiotherapy for prostate cancer. Multinational Association of Supportive Care and Cancer, Athens, Greece, 25th June 2011. = published abstract.
10. K Gough, et al (oral presentation) Sexual and hormonal quality of life differences between clinical subgroups of men commencing radiotherapy for prostate cancer. Victorian Integrated Cancer Services Supportive Care Conference, Melbourne, 11th July 2011.
11. P Schofield (oral presentation and poster) A nurse-led group consultation intervention to reduce psychological morbidity and unmet needs in men with prostate cancer during radiotherapy: A randomised controlled trial. 12th Australasian Prostate Cancer Conference, Melbourne, 5th August 2011.
12. P Schofield (oral presentation and poster) Unmet needs, psychological distress and quality of life in men commencing radiotherapy for prostate cancer. 12th Australasian Prostate Cancer Conference, Melbourne, 5th August 2011.
13. R Bergin (oral presentation and poster) Patterns and predictors of psychological morbidity, unmet needs and quality of life in men with prostate cancer who receive curative radiotherapy. 12th Australasian Prostate Cancer Conference, Melbourne, 5th August 2011.
14. K Schubach (poster presentation) The impact of androgen deprivation on physical, psychological and quality of life outcomes in men with prostate cancer. 12th Australasian Prostate Cancer Conference, Melbourne, 5th August 2011.
15. P Schofield et al, (oral presentation) A nurse-led psycho-educational group intervention to reduce psychological morbidity and unmet needs in men with prostate cancer during radiotherapy: A randomised controlled trial. International Psycho-Oncology Society conference, Anatalya, Turkey, 18th October 2011. = published abstract. Psychooncology 2011, Vol 20:Issue S2, 47-8
16. W Crellin and K Schubach. (oral presentation) Involving consumers in research: Fore-warned is Fore-armed – Supportive Care for Men with Prostate Cancer. Nurses for Continence ANF (Vic Branch) Special Interest Group Education Day, Melbourne, 24th March 2012
17. W Crellin (oral presentation) 'A Consumer's Journey through the World of Health Research' to the Department of Health Victoria's forum 'Consumer Issues for Participation in Clinical Trials', Melbourne, Australia, April 27th, 2012.
18. R Bergin (oral presentation), M Collins, K Hun Tai, F Foroudi, K Lotfi-Jam, W Crellin, S Aranda, P Schofield. Patterns and predictors of psychological morbidity and quality of life in men with prostate cancer who receive curative radiotherapy. International Psycho-Oncology Society conference, Brisbane, Australia, 14th November 2012. = published abstract.
Public notes

Contacts
Principal investigator
Name 35659 0
A/Prof Penelope Schofield
Address 35659 0
Peter MacCallum Cancer Centre
St Andrews Pl
East Melbourne
VIC 3002
Country 35659 0
Australia
Phone 35659 0
+61 3 9656 3560
Fax 35659 0
Email 35659 0
penelope.schofield@petermac.org
Contact person for public queries
Name 10234 0
A/Prof Penelope Schofield
Address 10234 0
Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne VIC 8006
Country 10234 0
Australia
Phone 10234 0
+61 3 96563560
Fax 10234 0
+61 3 96561337
Email 10234 0
Penelope.Schofield@petermac.org
Contact person for scientific queries
Name 1162 0
A/Prof Penelope Schofield
Address 1162 0
Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne VIC 8006
Country 1162 0
Australia
Phone 1162 0
+61 3 96563560
Fax 1162 0
+61 3 96561337
Email 1162 0
Penelope.Schofield@petermac.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary