Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000306819
Ethics application status
Approved
Date submitted
15/03/2012
Date registered
16/03/2012
Date last updated
29/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Living Well with Prostate Cancer: A randomised controlled trial of a mindfulness intervention for men with advanced prostate cancer
Scientific title
Living Well with Prostate Cancer: A randomised controlled trial of a telelephone delivered mindfulness-based cognitive group intervention to reduce psychological distress and improve quality of life in men with advanced prostate cancer
Secondary ID [1] 280107 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Prostate Cancer 286022 0
Psychological Distress in men with advanced prostate cancer 286023 0
Quality of Life in men with advanced prostate cancer 286024 0
Supportive Care in men with advanced prostate cancer 286025 0
Condition category
Condition code
Cancer 286212 286212 0 0
Prostate
Public Health 286213 286213 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The mindfulness-based cognitive therapy (MBCT) group intervention will include tele-based group cognitive therapy and home practice. The group therapy sessions will be conducted weekly over 8 weeks and will each be between one and one and a half hours in length. Each group will contain seven men, and be facilitated by health professionals with experience in oncology, professional training in MBCT and training in the telephone delivery of interventions. Participants in the intervention will also be provided with a workbook summarising each weekly session and including interactive worksheets to keep group discussions on task; self-help materials; and a meditation CD. Participants who are randomised to the intervention condition will be mailed the intervention materials and allocated to a therapy group immediately after randomisation.
Intervention code [1] 284436 0
Behaviour
Comparator / control treatment
Patient education will consist of the man’s standard medical management and a package containing existing patient education materials. These will include the consumer version of the Clinical Practice Guidelines for Advanced Prostate Cancer, patient booklets on coping with cancer and tip sheets, and a CD on stress management and relaxation. These materials will be used at the participant's discretion. Participants who are randomised to the Patient Education condition will receive the package of materials immediately after randomisation.
Control group
Active

Outcomes
Primary outcome [1] 286686 0
Anxiety and Depression (assessed through self-report measures)
Timepoint [1] 286686 0
Baseline and at 3, 6 and 9 months after recruitment
Primary outcome [2] 286687 0
Cancer Specific Distress (assessed through self-report measures)
Timepoint [2] 286687 0
Baseline and at 3, 6 and 9 months after recruitment
Secondary outcome [1] 296459 0
Quality of Life (assessed through self-report measures)
Timepoint [1] 296459 0
Baseline and at 3, 6 and 9 months after recruitment
Secondary outcome [2] 296460 0
Post-Traumatic Growth (assessed through self-report measures)
Timepoint [2] 296460 0
Baseline and at 3, 6 and 9 months after recruitment
Secondary outcome [3] 296461 0
Economic evaluation (assessed through expenses associated with implementation of the intervention)
Timepoint [3] 296461 0
Ongoing throughout intervention
Secondary outcome [4] 296462 0
Therapy communication analysis (of group therapy telephone sessions)
Timepoint [4] 296462 0
Ongoing throughout intervention

Eligibility
Key inclusion criteria
Patients must:
(1) have proven metastatic prostate cancer or castration resistant biochemical progression;
(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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must not:
(1) have localised prostate cancer or biochemical progression of their prostate cancer only;
(2) have previous head injury or dementia;
(3) be unable to read and write English;
(4) be undergoing 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)
Eligible participants will be ascertained directly through clinicians in the Australian and New Zealand Urogenital and Prostate Cancer Trials Group and in major treatment centres in Queensland, New South Wales, Victoria and Western Australia. These clinicians will give eligible patients a brochure about the study and a form on which the patient can consent to being contacted by the research team.

Research staff will then contact the patient to give them additional information about the study, send a consent package (including an information sheet and consent form), seek informed consent, confirm eligibility and complete the baseline assessment. For eligible participants, randomisation will occur at the completion of all baseline data collection and the receipt of a signed consent form. 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
1/09/2012
Actual
30/09/2012
Date of last participant enrolment
Anticipated
31/01/2015
Actual
2/02/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
190
Accrual to date
Final
190
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 5093 0
4000-4999
Recruitment postcode(s) [2] 5094 0
2000-2599
Recruitment postcode(s) [3] 5095 0
2619-2898
Recruitment postcode(s) [4] 5096 0
2921-2999
Recruitment postcode(s) [5] 5097 0
3000-3999
Recruitment postcode(s) [6] 5098 0
6000-6797

Funding & Sponsors
Funding source category [1] 284870 0
Government body
Name [1] 284870 0
National Health and Medical Research Council
Country [1] 284870 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] 283748 0
University
Name [1] 283748 0
Griffith University
Address [1] 283748 0
170 Kessels Road
Nathan QLD 4111
Country [1] 283748 0
Australia
Other collaborator category [1] 260612 0
Other Collaborative groups
Name [1] 260612 0
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Address [1] 260612 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country [1] 260612 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286855 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 286855 0
Ethics committee country [1] 286855 0
Australia
Date submitted for ethics approval [1] 286855 0
Approval date [1] 286855 0
02/03/2012
Ethics approval number [1] 286855 0
PSY/15/12/HREC
Ethics committee name [2] 287553 0
Metro North Health Service District - The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [2] 287553 0
Ethics committee country [2] 287553 0
Australia
Date submitted for ethics approval [2] 287553 0
Approval date [2] 287553 0
21/06/2012
Ethics approval number [2] 287553 0
HREC/12/QPCH/101

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33892 0
Prof Suzanne Chambers
Address 33892 0
Menzies Health Institute Queensland
Bldg G05_2.44
Gold Coast Campus
Griffith University QLD 4222
Country 33892 0
Australia
Phone 33892 0
+61 7 5678 0008
Fax 33892 0
Email 33892 0
[email protected]
Contact person for public queries
Name 17139 0
Melissa Legg
Address 17139 0
Cancer Council Queensland
PO Box 201
Spring Hill Qld 4004
Country 17139 0
Australia
Phone 17139 0
+61 7 3634 5191
Fax 17139 0
+61 7 3259 8509
Email 17139 0
[email protected]
Contact person for scientific queries
Name 8067 0
Suzanne Chambers
Address 8067 0
Menzies Health Institute Queensland
Bldg G05_2.44
Gold Coast Campus
Griffith University QLD 4222
Country 8067 0
Australia
Phone 8067 0
+61 7 5678 0008
Fax 8067 0
Email 8067 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
SourceTitleYear of PublicationDOI
EmbaseThe role of mindfulness in distress and quality of life for men with advanced prostate cancer.2016https://dx.doi.org/10.1007/s11136-016-1341-3
N.B. These documents automatically identified may not have been verified by the study sponsor.