Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000184471
Ethics application status
Approved
Date submitted
10/11/2015
Date registered
12/02/2016
Date last updated
23/01/2019
Date data sharing statement initially provided
23/01/2019
Date results provided
23/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Development and pilot testing of patient resources to support implementation of the Anxiety and Depression Pathway (ADAPT) Program: A Clinical Pathway for the screening, assessment and management of anxiety and depression in adult patients with cancer
Scientific title
Development and pilot testing of patient resources to support implementation of the Anxiety and Depression Pathway (ADAPT) Program: A Clinical Pathway for the screening, assessment and management of anxiety and depression in adult patients with cancer
Secondary ID [1] 287818 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 296696 0
anxiety 296697 0
depression 296698 0
Condition category
Condition code
Cancer 296932 296932 0 0
Any cancer
Mental Health 296933 296933 0 0
Anxiety
Mental Health 296934 296934 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be provided with website content (in printed format) and a pamphlet about a clinical pathway for screening for anxiety and depression. The clinical pathway was developed by a working group led by PoCoG at the University of Sydney and has been published in Psycho-Oncology. Participants will participate in either a focus groups or semi-structured interview with the aim to collect feedback on the website content and pamphlet, and the participant's understanding of clinical pathways more broadly. Participants will be given the materials at least 2 weeks prior to the focus group or interview date. Focus groups and semi-structured interviews will be conducted by the lead investigator or research officer.
Intervention code [1] 293210 0
Other interventions
Comparator / control treatment
As this is a qualitative study and intended to collect feedback on specific materials, there is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296578 0
Receiving patient feedback on the website and pamphlet. This will be assessed with a qualitative analysis of the data collected in focus groups and semi-structured interviews.
Timepoint [1] 296578 0
At the completion of the focus group or semi-structured interview.
Secondary outcome [1] 318801 0
Determining patient understanding of clinical pathways. This will be assessed with a qualitative analysis of the data collected in focus groups and semi-structured interviews.
Timepoint [1] 318801 0
At the completion of the focus group or semi-structured interview.

Eligibility
Key inclusion criteria
Eligible patients:
*Will have a confirmed diagnosis of cancer
*Will be able to read and write English;
*Are over the age of 18 years
*Will be able to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Qualitative analysis will be used to determine the extent of participant understanding of the clinical pathway and their acceptance of its use.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/02/2016
Actual
28/04/2016
Date of last participant enrolment
Anticipated
31/10/2016
Actual
31/08/2016
Date of last data collection
Anticipated
Actual
9/09/2016
Sample size
Target
20
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4603 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 4604 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [3] 4605 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 12205 0
2050 - Camperdown
Recruitment postcode(s) [2] 12206 0
2139 - Concord Repatriation Hospital

Funding & Sponsors
Funding source category [1] 292363 0
Government body
Name [1] 292363 0
Cancer Institute NSW
Country [1] 292363 0
Australia
Primary sponsor type
Individual
Name
Dr Heather Shepherd
Address
Psycho-oncology Co-operative Research Group (PoCoG)
Level 6 Chris O'Brien Lifehouse (C39Z)
The University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 291042 0
None
Name [1] 291042 0
Address [1] 291042 0
Country [1] 291042 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293833 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 293833 0
Ethics committee country [1] 293833 0
Australia
Date submitted for ethics approval [1] 293833 0
25/11/2015
Approval date [1] 293833 0
28/01/2016
Ethics approval number [1] 293833 0

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

Contacts
Principal investigator
Name 61398 0
Dr Heather Shepherd
Address 61398 0
ADAPT Research Fellow and Program Manager
Psycho-oncology Co-operative Research Group (PoCoG)
Level 6 Chris O'Brien Lifehouse (C39Z)
The University of Sydney NSW 2006
Country 61398 0
Australia
Phone 61398 0
+ 61 2 8627 0828
Fax 61398 0
+61 2 9036 5292
Email 61398 0
heather.shepherd@sydney.edu.au
Contact person for public queries
Name 61399 0
Heather Shepherd
Address 61399 0
ADAPT Program Manager, Psycho-oncology Co-operative Research Group (PoCoG) Level 6 Chris O'Brien Lifehouse (C39Z) The University of Sydney NSW 2006
Country 61399 0
Australia
Phone 61399 0
+61286270828
Fax 61399 0
+61 2 9036 5292
Email 61399 0
heather.shepherd@sydney.edu.au
Contact person for scientific queries
Name 61400 0
Heather Shepherd
Address 61400 0
ADAPT Research Fellow and Program Manager
Psycho-oncology Co-operative Research Group (PoCoG)
Level 6 Chris O'Brien Lifehouse (C39Z)
The University of Sydney NSW 2006
Country 61400 0
Australia
Phone 61400 0
+ 61 2 8627 0828
Fax 61400 0
+61 2 9036 5292
Email 61400 0
heather.shepherd@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study data collection completed in 2016. Qualitative data and demographic data only.


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.