Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001490460
Ethics application status
Approved
Date submitted
24/10/2016
Date registered
27/10/2016
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Date results information initially provided
14/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Identifying and responding to anxiety and depression in adult cancer patients: Pilot testing of an on-line communication skills education program for oncology health professionals
Scientific title
Identifying and responding to anxiety and depression in adult cancer patients: Pilot testing of an on-line communication skills education program for oncology health professionals
Secondary ID [1] 290374 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 300680 0
Anxiety 300681 0
Depression 300682 0
Condition category
Condition code
Cancer 300528 300528 0 0
Any cancer
Mental Health 300529 300529 0 0
Anxiety
Mental Health 300530 300530 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an online training program designed for cancer health professionals and provides education on a clinical pathway into the screening and management of anxiety and depression in adult cancer patients. The online training modules provide health professionals with communication skills training and practical tips for having conversations with patients about screening and talking to patients about referrals for anxiety and depression. The training modules include videos of example scenarios (played by actors) to teach these skills. The online education also includes videos from current health professionals talking about their experiences of screening and management of patients with anxiety and depression. The online training takes 4 hours to complete however does not need to be completed in a single sitting. Participants may save their progress at any time and return to complete later. The training is made up of 5 modules:
Module 1: Anxiety and Depression in Cancer
Module 2: A Stepped Care Model for Anxiety and Depression in Cancer
Module 3: Initiating a Conversation about Routine Screening for Anxiety and Depression in Cancer
Module 4: Initiating a Conversation about Referral to Psycho-oncology Services
Module 5: Managing Declining Referral in at Risk Patients and other Challenging Conversations

The online training will be hosted by eviQ, the Cancer Institute NSW’s clinical education website. eviQ will provide analytics to the research team to allow monitoring of adherence.
Intervention code [1] 296201 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299951 0
The primary outcome of the study is acceptability of the online training. This will be assessed by participant questionnaires specifically designed for this study.
Timepoint [1] 299951 0
Within 2 weeks of completing the training.
Secondary outcome [1] 328639 0
The secondary outcome of this study is effectiveness of the training to improve communication related to screening and referral. This will be assessed by analysing the filmed scenarios for competency in communication related to screening and referral.
Timepoint [1] 328639 0
Within 2 weeks of completing the training.

Eligibility
Key inclusion criteria
1. Health professionals working in oncology where discussing anxiety and depression is part of their current role
2. Ability to complete the study questionnaires and participate in the medical simulations
3. Aged 18 years or over
4. Provision of informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Health professionals not working in oncology
2. Health professionals unable to complete both pre and post training simulation assessments

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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/10/2016
Actual
26/10/2016
Date of last participant enrolment
Anticipated
30/11/2016
Actual
25/09/2017
Date of last data collection
Anticipated
16/12/2016
Actual
3/11/2017
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294765 0
Government body
Name [1] 294765 0
Cancer Institute NSW
Country [1] 294765 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 293611 0
None
Name [1] 293611 0
Address [1] 293611 0
Country [1] 293611 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296172 0
St Vincent's Hospital HREC
Ethics committee address [1] 296172 0
Translational Research Centre
97 - 105 Boundary St
Darlinghurst
NSW 2010
Ethics committee country [1] 296172 0
Australia
Date submitted for ethics approval [1] 296172 0
26/09/2016
Approval date [1] 296172 0
12/10/2016
Ethics approval number [1] 296172 0
HREC/16/SVH/243

Summary
Brief summary
The primary purpose of this study is to assess the acceptability and efficacy of an online training program for oncology health professionals for aiding with the screening and management of anxiety and depression in adults with cancer.

Who is it for?
You may be eligible to participate in this study if you are an oncology health professional in a role which involves discussing anxiety and depression.

Study details
All participants in this study will complete the online training program which consists of five modules and takes approximately four hours to complete. It includes explanations about talking to patients and videos with acted scenarios. Participants will complete a questionnaire and participate in three patient simulated consultations (where patients are played by actors) before and after receiving online training to evaluate program acceptability and efficacy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69858 0
Dr Joanne Shaw
Address 69858 0
Level 6 – North, Chris O’Brien Lifehouse
119-143 Missenden Rd (C39Z)
The University of Sydney
NSW 2006
Country 69858 0
Australia
Phone 69858 0
+61 2 9351 3761
Fax 69858 0
Email 69858 0
joanne.shaw@sydney.edu.au
Contact person for public queries
Name 69859 0
Ms Jessica Cuddy
Address 69859 0
Level 6 – North, Chris O’Brien Lifehouse
119-143 Missenden Rd (C39Z)
The University of Sydney
NSW 2006
Country 69859 0
Australia
Phone 69859 0
+61 2 8627 4244
Fax 69859 0
Email 69859 0
jessica.cuddy@sydney.edu.au
Contact person for scientific queries
Name 69860 0
Dr Joanne Shaw
Address 69860 0
Level 6 – North, Chris O’Brien Lifehouse
119-143 Missenden Rd (C39Z)
The University of Sydney
NSW 2006
Country 69860 0
Australia
Phone 69860 0
+61 2 9351 3761
Fax 69860 0
Email 69860 0
joanne.shaw@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 consent form states: "Any information obtained in connection with this research project that is identifiable will remain confidential."


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
787Study protocol    371700-(Uploaded-14-12-2018-16-50-55)-Study-related document.docx



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.