Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000560796
Ethics application status
Approved
Date submitted
22/03/2013
Date registered
17/05/2013
Date last updated
20/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Communication Skills Training for Oncology Health Professionals working with Culturally and Linguistically Diverse Patients
Scientific title
For oncology health professionals working with culturally and linguistically diverse patients, will a communication skills training intervention delivered online and through face-to-face workshops be superior to delivery online alone at improving clinical communication skills.
Secondary ID [1] 282164 0
Nil
Universal Trial Number (UTN)
U1111-1140-9239
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
health communication 288670 0
Condition category
Condition code
Cancer 289019 289019 0 0
Any cancer
Public Health 289382 289382 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stage 1 - Focus groups will be conducted with 30 health professionals with previous experience working with cancer patients from cultural and linguistically diverse (CALD) backgrounds. Participants will be asked to undertake a 60 min focus group that will explore personal cultural awareness and values surrounding diversity; problem areas of communication with CALD patients; perceived barriers and enablers to effective communication with CALD patients; issues involved in working with interpreters; coping with divergent cultural beliefs about cancer. Stage 2 - The findings from Stage 1 will inform the development of two communication skills training (CST) interventions - a self-paced (2 hour total duration) interactive online component and a 1 1/2 hr workshop. The workshop will be conducted after participants have undertaken the online component, and will use role-play simulations to demonstrate how to apply communication skills in a realistic clinical scenario. Stage 3 - Randomised phase II feasibility study. Approximately 140 health professionals will be randomised to either 1) complete the online CST intervention only or 2) complete the online intervention followed by the 1 1/2 hr workshop. Both groups will complete the same online intervention. Both groups will be given 2 weeks from completing the baseline questionnaire within which to complete the online program. Participants will be asked to complete a baseline questionnaire (T1), post-intervention questionnaire immediately after (T2), and then again six months post-intervention (T3). The questionnaire will evaluate the perceived impact of the interventions on actual clinical practice, confidence, and readiness to experiment with culturally competent communication. Usage data will be collected including time spent online, modules accessed, duration and completion of each module, time of day of access to modules. The workshop will be undertaken within 12 weeks of completing the online program.
Intervention code [1] 286772 0
Behaviour
Comparator / control treatment
Group 1 - oncology health professionals undertaking an online communication skills training (CST) program

Comparator (Group 2) - oncology health professionals undertaking an online CST program + 1 1/2 hr face-to-face workshop
Control group
Active

Outcomes
Primary outcome [1] 289130 0
Self-rated competence in communicating with CALD patients. This measure includes 8 Likert-type items adapted from previous CST studies.
Timepoint [1] 289130 0
T2 (post-intervention)
T3 (six months post-intervention)
Primary outcome [2] 289131 0
Perceived practice and readiness to communicate in a culturally competent manner -
This measure includes 16 Likert-type response items. These will be framed to assess the frequency of behaviours eg "How often do you check understanding of complex concepts with your CALD patients?" (practice) or "How likely are you to try out different ways of dealing with the same communication problem involving CALD patients?" (readiness)
Timepoint [2] 289131 0
T2 (post-intervention)
T3 (six months post-intervention)
Primary outcome [3] 289132 0
Satisfaction with the intervention -
This measure includes 7 Likert-type response items that will assess different components of the interventions including: perceived relevance, usefulness, and acceptability; relevance of cultural scenarios; quality of case scenarios. Participants allocated to the online +workshop intervention arm will also be assessed on perceived quality of the facilitation, perceived usefulness of feedback and the opportunity to practise skills through role-playing.
Timepoint [3] 289132 0
T2 (post-intervention)
Secondary outcome [1] 301898 0
Functionality -
Three items will assess the functionality of the online intervention including ease of navigating the website, quality and ease of viewing the video case studies online, and the ease of accessing additional resources.
Timepoint [1] 301898 0
T2 (post-intervention)
Secondary outcome [2] 301899 0
Preference for format of intervention -
Approximately 15 items will elicit preferences for the process, length, content, and format of the interventions. For example: "I would prefer to attend a workshop of longer/shorter duration." or "I would have like the online website to be shorter."
Timepoint [2] 301899 0
T2 (post-intervention)

Eligibility
Key inclusion criteria
Health professionals that:
- have worked for at least two consecutive years in an oncology setting AND
- have worked as a medical or radiation oncologist or an oncology nurse AND
- have adequate English literacy and communication skills
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Health professionals that:
- have not worked in an oncology setting
- have worked for less than two consecutive years in an oncology setting
- are unable to give informed consent

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)
Interested health professionals will be directed to click on a link in the email invitation in order to receive a unique username and password that will enable him/her to access the secure study website. At the study website the health professionals will be prompted to provide informed consent and to complete the pre-intervention questionnaire. After completion of the pre-intervention questionnaire, participants will be randomly allocated to either the 1) online group or 2) the online + workshop group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using an online randomisation tool, integrated into the study website.
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
Descriptive statistics will be used to explore the data.
Allowing for a loss to follow up at six months of 10%, a sample size of 71 in each intervention group will be included at baseline to achieve a final sample size at the six-month follow up of 64. This will detect changes across time in self-rated confidence in communicating with CALD patients of 0.5 of an effect size with 80% power at a 5% significance level (2-sided), which we consider a clinically significant change.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2013
Actual
1/04/2013
Date of last participant enrolment
Anticipated
28/09/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
142
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 286931 0
Government body
Name [1] 286931 0
ARC Linkage Grant
Country [1] 286931 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Barker St
Randwick 2031
NSW
Country
Australia
Secondary sponsor category [1] 285719 0
Hospital
Name [1] 285719 0
Memorial Sloan-Kettering Cancer Centre
Address [1] 285719 0
1275 York Avenue
New York, NY 10065
Country [1] 285719 0
United States of America
Secondary sponsor category [2] 285720 0
University
Name [2] 285720 0
University of Sydney
Address [2] 285720 0
Wentworth Bldg,
Butlin Ave, Darlington NSW 2006
Country [2] 285720 0
Australia
Other collaborator category [1] 277326 0
Hospital
Name [1] 277326 0
Prince of Wales Hospital
Address [1] 277326 0
High St
Randwick, NSW 2031
Country [1] 277326 0
Australia
Other collaborator category [2] 277327 0
Other Collaborative groups
Name [2] 277327 0
Multicultural Health Service
Address [2] 277327 0
Division of Population Health
South Eastern Sydney Illawarra Health
Level 1, McNevin Dickson Building
Prince of Wales Hospital
Avoca Street
RANDWICK NSW 2031
Country [2] 277327 0
Australia
Other collaborator category [3] 277328 0
Charities/Societies/Foundations
Name [3] 277328 0
Cancer Institute NSW
Address [3] 277328 0
Australian Technology Park
Level 9, 8 Central Avenue
EVELEIGH NSW 2015
AUSTRALIA

Country [3] 277328 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288987 0
Medical & Community Human Research Ethics Advisory Panel, University of New South Wales
Ethics committee address [1] 288987 0
Ethics committee country [1] 288987 0
Australia
Date submitted for ethics approval [1] 288987 0
04/02/2013
Approval date [1] 288987 0
04/03/2013
Ethics approval number [1] 288987 0
2013-7-05

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

Contacts
Principal investigator
Name 38674 0
A/Prof Bettina Meiser
Address 38674 0
Psychosocial Research Group,
Lv 3, Dickinson Building
Prince of Wales Hospital
Barker St
Randwick NSW 2031
Country 38674 0
Australia
Phone 38674 0
61 2 9382 2638
Fax 38674 0
61 2 9382 3372
Email 38674 0
b.meiser@unsw.edu.au
Contact person for public queries
Name 38675 0
Elvira Zilliacus
Address 38675 0
Psychosocial Research Group
Lv 3, Dickinson Building
Prince of Wales Hospital
Barker St
Randwick NSW 2031
Country 38675 0
Australia
Phone 38675 0
61 2 9382 4404
Fax 38675 0
61 2 9382 3372
Email 38675 0
e.zilliacus@unsw.edu.au
Contact person for scientific queries
Name 38676 0
Elvira Zilliacus
Address 38676 0
Psychosocial Research Group
Lv 3, Dickinson Building
Prince of Wales Hospital
Barker St
Randwick NSW 2031
Country 38676 0
Australia
Phone 38676 0
61 2 9382 2611
Fax 38676 0
61 2 9382 3372
Email 38676 0
e.zilliacus@unsw.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
No additional documents have been identified.