Trial Review

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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
Sex
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
1/07/2006
Actual
16/01/2007
Date of last participant enrolment
Anticipated
Actual
16/12/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
330
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
Country [1] 1357 0
Australia
Funding source category [2] 290816 0
Government body
Name [2] 290816 0
National Health and Medical Research Council
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
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for public queries
Name 10234 0
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
[email protected]
Contact person for scientific queries
Name 1162 0
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
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.