Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000392965
Ethics application status
Approved
Date submitted
13/04/2011
Date registered
14/04/2011
Date last updated
27/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Living with Prostate Cancer: A Multimodal Supportive Care Intervention for Men with Prostate Cancer
Scientific title
A randomised controlled trial of a multimodal supportive care intervention to target unmet supportive care needs and improve overall wellbeing in men recently diagnosed with prostate cancer
Secondary ID [1] 259937 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 265537 0
Unmet Supportive Care Needs 265538 0
Quality of life 265541 0
Economic evaluation of the multimodal supportive care intervention to determine its relative economic efficiency 265542 0
Condition category
Condition code
Cancer 265694 265694 0 0
Prostate
Public Health 265695 265695 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The multimodal supportive care intervention will include self-management and tele-based group peer support. Self-management resources will be in both print and web-based form. A study website will be provided for participants to access program materials and other resources, and to interact in group discussions and forums. The intervention also includes group peer support calls for participants, co-facilitated by a specialist prostate cancer nurse counsellor and trained peer support volunteers. The groups will have up to 8 members, and will run for six months with monthly teleconferenced meetings. Participants who are randomised to the intervention condition will be mailed the patient materials and allocated to a peer support group immediately after randomisation.
Intervention code [1] 264349 0
Behaviour
Comparator / control treatment
Usual care will consist of the man's standard medical management and a package containing information on coping with diagnosis and treatment of prostate cancer, managing side-effects, nutrition, and an exercise booklet and DVD. Participants who are randomised to the Usual Care condition will receive the package of materials immediately after randomisation.
Control group
Active

Outcomes
Primary outcome [1] 266465 0
Unmet supportive care needs (assessed through self-report measures).
Timepoint [1] 266465 0
Baseline and at 3, 6 and 12 months after recruitment
Primary outcome [2] 266466 0
Physical activity levels (assessed through self-report measures).
Timepoint [2] 266466 0
Baseline and at 3, 6 and 12 months after recruitment
Secondary outcome [1] 273819 0
Domain-specific quality of life (assessed through self-report measures).
Timepoint [1] 273819 0
Baseline and at 3, 6 and 12 months after recruitment
Secondary outcome [2] 273820 0
Health-related quality of life (assessed through self-report measures).
Timepoint [2] 273820 0
Baseline and at 3, 6 and 12 months after recruitment
Secondary outcome [3] 273821 0
Psychological distress (assessed through self-report measures).
Timepoint [3] 273821 0
Baseline and at 3, 6 and 12 months after recruitment
Secondary outcome [4] 273824 0
Posttraumatic growth (assessed through self-report measures).
Timepoint [4] 273824 0
Baseline and at 3, 6 and 12 months after recruitment
Secondary outcome [5] 273825 0
Body mass index and waist circumference (assessed through self-report measures).
Timepoint [5] 273825 0
Baseline and at 3, 6 and 12 months after recruitment
Secondary outcome [6] 273826 0
Economic evaluation will be assessed through (1) self-report measures associated with out-of-pocket costs, disruption to work, travel costs; (2) expenses associated with implementation of the intervention.
Timepoint [6] 273826 0
Baseline and at 3, 6 and 12 months after recruitment
Secondary outcome [7] 273969 0
Utilisation of website (assessed through usage statistics from the website e.g. number of hits, topics accessed).
Timepoint [7] 273969 0
Ongoing throughout intervention
Secondary outcome [8] 273979 0
Group communication analysis (of group peer support telephone sessions)
Timepoint [8] 273979 0
Ongoing throughout intervention

Eligibility
Key inclusion criteria
Patients must:
(1) have recently been diagnosed with localised prostate cancer (men will be three to six months post-diagnosis at recruitment);
(2) be able to read and speak English;
(3) have no previous history of head injury, dementia or psychiatric illness;
(4) have no other concurrent cancer;
(5) have phone access;
(6) have physician clearance to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must not:
(1) have prostate cancer recurrence or progression;
(2) have advanced prostate cancer;
(3) have previous head injury or dementia;
(4) be unable to read and write English;
(5) be undergoing treatment for another cancer;
(6) be advised by their clinician that they should not participate in the study.

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)
Patients will be identified through the Queensland Cancer Registry (QCR), a population-based register of cancer diagnoses in Queensland, as being recently diagnosed with prostate cancer. The diagnosing clinician listed on the pathology record is contacted for permission to contact their patient about the study. The doctor will be sent a letter from the QCR about the study, along with an information sheet and consent form. If the doctor consents to the patient being contacted, the QCR sends a consent package (including a letter to the patient signed by the doctor, information sheet and consent form) seeking consent to participate in the study. The consent form includes consent for the release of contact details from the QCR to the research team. If the patient consents to participate by returning the completed consent form, QCR will provide the patient's details to the research team. Research staff will contact the patient to determine eligibility and complete baseline assessment. For eligible participants, randomisation will occur at the completion of all baseline data collection. Allocation concealment will occur, with randomisation being undertaken by computer 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.
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
1/07/2011
Actual
2/12/2011
Date of last participant enrolment
Anticipated
Actual
22/11/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
580
Accrual to date
Final
463
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 3896 0
4000-4999

Funding & Sponsors
Funding source category [1] 264811 0
Government body
Name [1] 264811 0
Cancer Australia
Country [1] 264811 0
Australia
Funding source category [2] 264880 0
Charities/Societies/Foundations
Name [2] 264880 0
beyondblue: the national depression initiative
Country [2] 264880 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Cancer Council Queensland
Address
PO Box 201
Spring Hill QLD 4004
Country
Australia
Secondary sponsor category [1] 263919 0
University
Name [1] 263919 0
Griffith University
Address [1] 263919 0
170 Kessels Road
Nathan QLD 4111
Country [1] 263919 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266783 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 266783 0
Office for Research
G39 Room 3.55 Gold Coast Campus
Griffith University QLD 4222
Ethics committee country [1] 266783 0
Australia
Date submitted for ethics approval [1] 266783 0
16/03/2011
Approval date [1] 266783 0
26/03/2011
Ethics approval number [1] 266783 0
PSY/F6/10/HREC

Summary
Brief summary
This study evaluates an innovative supportive care intervention to improve the well-being of men diagnosed with prostate cancer.

Who is it for?
This study is for men who have recently been diagnosed with localised prostate cancer in Queensland.

Trial details
In this study participants are randomly (by chance) divided into two groups. One group will receive usual care, i.e. currently available resource and support materials. The other group will receive the Living with Prostate Cancer supportive care intervention. This includes the provision of self-management resources in both print and web-based form, as well as access to a study website where participants can interact in group discussions and forums. The intervention also includes group peer support phone calls for participants led by trained peer support volunteers and a specialist prostate cancer nurse counsellor. The duration of this intervention is 6 months.

Participants will complete questionnaires at 3, 6 and 12 months after enrolling in the study to evaluate their psychological well-being and quality of life.
Trial website
Trial related presentations / publications
Galvao DA, Newton RU, Gardiner RA, Girgis A, Lepore SJ, Stiller A, Occhipinti S, Chambers SK. Compliance to exercise-oncology guidelines in prostate cancer survivors and associations with psychological distress, unmet supportive care needs, and quality of life. Psycho-Oncology. 2015; 24(10):1241-1249.

Chambers SK, Newton RU, Girgis A, Nielsen L, Lepore S, Mihalopoulos C, Gardiner RA, Galvao DA, Occhipinti S. Living with Prostate Cancer: Randomised Controlled Trial of a Multimodal Supportive Care Intervention for Men with Prostate Cancer. BMC Cancer. 2011; 11(1):317.
Public notes

Contacts
Principal investigator
Name 32329 0
Prof Suzanne Chambers
Address 32329 0
Griffith Health Institute GO5 Health Sciences, Room 2.13 Gold Coast Campus Griffith University QLD 4222
Country 32329 0
Australia
Phone 32329 0
+61 7 5678 0008
Fax 32329 0
Email 32329 0
suzanne.chambers@griffith.edu.au
Contact person for public queries
Name 15576 0
Ms Lisa Nielsen
Address 15576 0
Cancer Council Queensland
PO Box 201
Spring Hill Qld 4004
Country 15576 0
Australia
Phone 15576 0
+61 7 3634 5393
Fax 15576 0
+61 7 3259 8527
Email 15576 0
lisanielsen@cancerqld.org.au
Contact person for scientific queries
Name 6504 0
Prof Suzanne Chambers
Address 6504 0
Griffith Health Institute
GO5 Health Sciences, Room 2.13
Gold Coast Campus
Griffith University QLD 4222
Country 6504 0
Australia
Phone 6504 0
+61 7 5678 0008
Fax 6504 0
Email 6504 0
suzanne.chambers@griffith.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

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

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AICompliance to exercise-oncology guidelines in prostate cancer survivors and associations with psychological distress, unmet supportive care needs, and quality of life2015https://doi.org/10.1002/pon.3882
N.B. These documents automatically identified may not have been verified by the study sponsor.