Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000301268
Ethics application status
Approved
Date submitted
28/04/2009
Date registered
19/05/2009
Date last updated
6/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving the Psychosocial Health of People with Cancer and their Carers: A Community Based Approach
Scientific title
Improving the Psychosocial Health and Distress Levels of People with Cancer and their Carers through therapist-delivered or self-managed support intervention: A Community Based Approach
Secondary ID [1] 282449 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Beating the Blues After Cancer
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 4668 0
Psychosocial health 4669 0
Distress 4670 0
Economic evaluation of support interventions to determine its economic efficiency 4671 0
Condition category
Condition code
Cancer 4963 4963 0 0
Other cancer types
Public Health 4977 4977 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project is a randomised controlled trial comparing minimal contact ‘self help’ self management materials versus a tele-based psychologist delivered cognitive behavioural intervention. Group 1: The self-managed support arm will consist of an initial single 30-minute telephone support and education session with a nurse counsellor who will provide feedback to the participant about his/her levels of distress and instruction in evidence based strategies to improve adjustment. A resource package will also be provided as in kind support that will include a range of already developed audio and written patient education materials produced by The Cancer Council Queensland. The duration of the self-managed intervention for Group 1 will dictated by the participants utilisation of their resource material after the initial telephone contact by the nurse counsellor. Group 2: For the individualised cognitive behavioural intervention (therapist delivered), five one-hour sessions of tele-based counselling from a clinical psychologist will be delivered that include psycho-education, skills in stress reduction, problem-solving, cognitive challenging and enhancing relationship support. The individualised counselling sessions will include assigned behavioural homework that will be supported by work and tip sheets. It is anticipated that the 5 therapist delivered sessions for Group 2 will be conducted at regular intervals after randomisation and completed before follow-up assessment at 3 months.
Intervention code [1] 4501 0
Behaviour
Comparator / control treatment
On the ethical basis that these participants have demonstrated elevated psychological distress we will not utilise a ‘no treatment’ control group. This project is a randomised controlled trial comparing minimal contact ‘self help’ self management materials versus a tele-based psychologist delivered cognitive behavioural intervention.
Control group
Active

Outcomes
Primary outcome [1] 5810 0
Primary outcome 1: Psychological Distress will be assessed through self report measures
Timepoint [1] 5810 0
Baseline and at 3, 6 and 12 months after intervention commencement
Primary outcome [2] 5811 0
Primary outcome 2: Cancer specific distress will be assessed through self report measures
Timepoint [2] 5811 0
Baseline and at 3, 6 and 12 months after intervention commencement
Primary outcome [3] 5812 0
Primary outcome 3: Unmet Psychological Supportive Care Needs will be assessed through self report measures
Timepoint [3] 5812 0
Baseline and at 3, 6 and 12 months after intervention commencement
Secondary outcome [1] 241813 0
Seconday outcome 1: Positive adjustment will be assessed through self report measures
Timepoint [1] 241813 0
Baseline and at 3, 6 and 12 months after intervention commencement
Secondary outcome [2] 241814 0
Seconday outcome 2: Quality of life will be assessed through self report measures
Timepoint [2] 241814 0
Baseline and at 3, 6 and 12 months after intervention commencement
Secondary outcome [3] 241829 0
Secondary outcome 3: A trial-based economic evaluation will be conducted that integrates the efficacy and quality of life outcomes data with comparative cost data on the intervention options. The various distress indicators and the unmet needs data will be built in incremental cost-effectiveness analysis (CEA), while the quality of life data will be used in cost-utility analysis (CUA) using the Brazier algorithm. The feasibility of adding a modelled economic evaluation (to broaden the target population; lengthen the time horizon beyond that of the trial; and estimate cost offsets) will also be carefully assessed, having regard to trial results and the strength of evidence in the literature to underpin key modelling assumptions.
Costs and outcomes will be assessed from a health sector perspective, but with a focus on government as 3rd party funder. Cost impacts that fall on patients and their carers/families will be reported to the extent they can be assessed from the activity data; but this collection will not be complete. Pathway analysis and patient flowcharts (incorporating decision tree analysis) will be used to clearly identify and cost the activity components for each arm of the trial. Standard discounting will be applied to both costs and outcomes, together with detailed sensitivity testing (using @RISK probabilistic software).
Timepoint [3] 241829 0
Baseline and at 3, 6 and 12 months after intervention commencement

Eligibility
Key inclusion criteria
Patients suffering from any form of cancer or carers of those suffering from any form of cancer who contact the Cancer Helpline in both Queensland and New South Wales, have a score of 4 or over on the Brief Distress Thermometer at the time of Helpline contact, be able to read and speak English, be an adult aged 18 years or over and have no previous history of head injury, dementia or psychiatric illness.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A caller to the Cancer Helpline who is not a patient or carer, a score under 4 on the Brief Distress Thermometer at time of Helpline contact, under the age of 18 years, unable to read and speak English, a previous history of head injury, dementia or psychiatric illness

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)
Cancer Helpline staff will identify potential participants who meet study inclusion criteria and will invite participation into the study. Verbal permission to be contacted by the research team will be obtained and
information sheet and consent forms posted. Project staff will telephone potential participants within a couple of days of initial contact to discuss the information sheet and ensure study eligibility. The initial contact is designed to explain the research in more detail, assess the person's interest in participating, determine eligibility and where appropriate to conduct the baseline
assessment. Following baseline assessment participants will be randomly allocated to an intervention group. Intervention allocation will be via central randomisation by a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by patient/carer and state (QLD vs NSW) and will occur in blocks. Simple randomisation will be achieved by using a random number generator (within Stata SE 10.1) based on the Uniform distribution. This sequence will be undertaken by the project manager and concealed from investigators.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Two group randomised controlled trial: self-managed support; therapist-delivered support intervention
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2009
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
3/08/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
560
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1627 0
4006
Recruitment postcode(s) [2] 1628 0
2011

Funding & Sponsors
Funding source category [1] 4838 0
Government body
Name [1] 4838 0
Cancer Australia
Country [1] 4838 0
Australia
Funding source category [2] 4839 0
Charities/Societies/Foundations
Name [2] 4839 0
beyondblue
Country [2] 4839 0
Australia
Funding source category [3] 4841 0
Government body
Name [3] 4841 0
National Health and Medical Research Council
Country [3] 4841 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] 4378 0
University
Name [1] 4378 0
Centre for Health Research & Psycho-oncology (CHeRP), The University of Newcastle
Address [1] 4378 0
University of Newcastle
Room 230A
Level 2
David Maddison Building
Callaghan
NSW 2308
Country [1] 4378 0
Australia
Secondary sponsor category [2] 4379 0
Charities/Societies/Foundations
Name [2] 4379 0
Cancer Council NSW
Address [2] 4379 0
PO Box 572
Kings Cross NSW 1340
Country [2] 4379 0
Australia
Other collaborator category [1] 652 0
University
Name [1] 652 0
Griffith University
Address [1] 652 0
School of Psychology
Room 4.09
Psychology Building (M24)
Griffith University
176 Messines Ridge Road
Mt Gravatt Qld 4122
Country [1] 652 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6895 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 6895 0
Ethics committee country [1] 6895 0
Australia
Date submitted for ethics approval [1] 6895 0
20/03/2009
Approval date [1] 6895 0
24/04/2009
Ethics approval number [1] 6895 0
PSY/19/09/HREC

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

Contacts
Principal investigator
Name 29527 0
Prof Suzanne Chambers
Address 29527 0
Griffith Health Institute GO5 Health Sciences, Room 2.13 Gold Coast Campus Griffith University QLD 4222
Country 29527 0
Australia
Phone 29527 0
+61 7 5678 0008
Fax 29527 0
Email 29527 0
[email protected]
Contact person for public queries
Name 12774 0
Suzanne Chambers
Address 12774 0
Griffith Health Institute GO5 Health Sciences, Room 2.13 Gold Coast Campus Griffith University QLD 4222
Country 12774 0
Australia
Phone 12774 0
+61 7 5678 0008
Fax 12774 0
N/A
Email 12774 0
[email protected]
Contact person for scientific queries
Name 3702 0
Suzanne Chambers
Address 3702 0
Griffith Health Institute GO5 Health Sciences, Room 2.13 Gold Coast Campus Griffith University QLD 4222
Country 3702 0
Australia
Phone 3702 0
+61 7 5678 0008
Fax 3702 0
N/A
Email 3702 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
Dimensions AIBeating the blues after Cancer: randomised controlled trial of a tele-based psychological intervention for high distress patients and carers2009https://doi.org/10.1186/1471-2407-9-189
EmbaseEconomic evaluation of a psychological intervention for high distress cancer patients and carers: costs and quality-adjusted life years.2016https://dx.doi.org/10.1002/pon.4020
N.B. These documents automatically identified may not have been verified by the study sponsor.