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Trial registered on ANZCTR


Registration number
ACTRN12619001507178
Ethics application status
Approved
Date submitted
1/10/2019
Date registered
31/10/2019
Date last updated
31/10/2019
Date data sharing statement initially provided
31/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to see how educational websites for cancer doctors, nurses, patients and family carers affect family carer involvement medical consultations.
Scientific title
Empowering the clinician-patient-carer TRIO: A Phase III RCT of novel online education modules to facilitate effective family carer involvement in oncology
Secondary ID [1] 299175 0
None
Universal Trial Number (UTN)
Trial acronym
eTRIO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 314402 0
Condition category
Condition code
Cancer 312737 312737 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will be using two interventions, which are online education modules entitled "eTRIO" for cancer clinicians and "eTRIO-pc" for people with cancer and their family carers. These intervention resources were designed specifically for this study.

Participating cancer clincians will complete eTRIO over a 3 week period.

Participating patient-carer dyads will complete eTRIO-pc prior to their first, second or third consultation with a participating cancer clincian.

To monitor adherance to the interventions, participants will recieve automated email reminders from the study website. The research team will also access website analytics to monitor participants' use of the intervention websites.

Details about the aims and content of each intervention are as follows:

eTRIO for oncology clinicians (doctors and nurses): Aims to improve clinicians’ confidence and skills in facilitating family involvement in cancer consultations, and managing challenging situations involving family carers. Includes 14 sections, each covering a specific topic area (e.g. managing conflicting patient-family treatment wishes, dealing with angry family members); practical strategies and example wording; 9 professionally-produced short films and engaging interactive activities. Particpants will be required to complete the first 7 sections, and then choose 4 of the final 7 sections to complete also. It will take participants approximately 2 hours to complete the intervention.

eTRIO-pc for cancer patients and carers: Aims to educate, mobilise and empower patients and carers in interactions with clinicians, and to increase carer involvement to the level the patient/carer prefer. It includes 3 short scenario videos modelling useful skills/behaviours (e.g. carer introducing themself to clinician, asking questions, advocating for the patient); videos with clinicians, a patient and a carer discussing important aspects of family involvement and several interactive activities. It will take participants approximately 1 hour to complete the intervention.
Intervention code [1] 315553 0
Behaviour
Comparator / control treatment
The two eTRIO interventions will be compared to two NSW Health Carer Support Websites.

Participating cancer clincians will visit the NSW Health "Support for Carers" website over a 3 week period.

Partcipating patient-carer dyads will visit the NSW Health "Walking with Carers" website prior to their first, second or third consultation with a participating cancer clinician.

Participants will not be required to access the control resources for any minimum period of time. How long a participant accesses the resources for will be at the discretion of the participant.

To monitor adherance with the comparators, participants in the control groups will recieve manual email reminders at the same frequency as the participants allocated to the intervention groups.

Details about the aims and content of the two NSW Health websites are as follows:

The NSW Health 'Support for carers' (clinician) website provides information on carer identification, obligations to carers, as well as links to resources such as ‘creating a carer culture’, ‘carer friendly models of care’, carer support services, and information on patient privacy.

The NSW Health ‘Walking with carers’ (patient/carer) website provides information on the rights and responsibilities of carers, information about health services and government assistance, carer health and wellbeing, and caregiving role information.
Control group
Active

Outcomes
Primary outcome [1] 321375 0
Carer enagement in the consultation, measured with audio recorded consultation transcripts coded for carer-relevant behaviours, using an adapted version of the validated 80-item KINcode behavioural coding system (R. Laidsaar-Powell, Butow, Bu, Dear, et al., 2016).
Timepoint [1] 321375 0
First consultation post-intervention
Secondary outcome [1] 374805 0
Clinician self-efficacy in triadic communication, measured with purpose-built 10-item questionnaire.
Timepoint [1] 374805 0
1-week, 12-weeks and 26-weeks post-intervention.
Secondary outcome [2] 374806 0
Clinicians' use of practical strategies/policies for including family carers, measured using 12 purpose-built questions how clinicians welcome and manage family carers in their workplace.
Timepoint [2] 374806 0
12-weeks and 26-weeks post-intervention.
Secondary outcome [3] 374807 0
Clinicians' knowledge of strategies for communicating with family carers, measured using purpose-designed vignettes.
Timepoint [3] 374807 0
1-week, 12-weeks and 26-weeks post intervention,
Secondary outcome [4] 374808 0
Clincian preferences for the involvement of family carers in communication/decision-making, using 2 questions developed by Shin et al, 2013.
Timepoint [4] 374808 0
1-week, 12-weeks and 26-weeks post-intervention.
Secondary outcome [5] 374809 0
Patient self-efficacy in interactions with their oncologist or nurse measured using the 5-item Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) questionnaire (Maly et al., 1998); with 2 additional items.
Timepoint [5] 374809 0
1-week, 12-weeks and 26-weeks post intervention
Secondary outcome [6] 374810 0
Patient satisfaction with communication with their oncologist/nurse will be measured using a purpose-designed 25-item Consultation Satisfaction Scale.
Timepoint [6] 374810 0
1-week, 12-weeks and 26-weeks post-intervention
Secondary outcome [7] 374811 0
Patient distress assessed with the 21-item Depression, Anxiety and Stress Scale: DASS-21
Timepoint [7] 374811 0
1-week, 12-weeks and 26-weeks post-intervention
Secondary outcome [8] 374813 0
Patient health expenditure will be measured with a purpose designed incurred cost questionnaire will document patient GP/specialist visits, hospital stays, counselling and other support services.
Timepoint [8] 374813 0
1-week, 12-weeks and 26-weeks post-intervention.
Secondary outcome [9] 374814 0
Carers' preparedness for caregiving, assessed using the 8-item Preparedness for Caregiving Scale (PCS) (Archbold et al., 1990).
Timepoint [9] 374814 0
1-week, 12-weeks and 26-weeks post-intervention
Secondary outcome [10] 374815 0
Patient-carer communication will be assessed with 2 subscales of the Health Literacy of Caregivers Scale - Cancer (HLCS-C)
Timepoint [10] 374815 0
1-week, 12-weeks and 26-weeks post-intervention
Secondary outcome [11] 374816 0
Carer health literacy with be assessed with a Single Item Literacy Screener (SILS) (Morris, MacLean, Chew, & Littenberg, 2006).
Timepoint [11] 374816 0
1-week, 12-weeks and 26-weeks post-intervention
Secondary outcome [12] 374817 0
Usability of the interventions (online modules), assessed using the 10-item System Usability Scale
Timepoint [12] 374817 0
1-week post intervention
Secondary outcome [13] 374818 0
User engagement with the intervention (online modules), assessed through website analytics including time spent on the intervention and number of pages accesses.
Timepoint [13] 374818 0
Immediately post-intervention
Secondary outcome [14] 376035 0
Patient health literacy, assessed using 4 screening questions from Halverson et al. (2015).
Timepoint [14] 376035 0
1-week , 12-weeks, and 26-weeks post-intervention/control
Secondary outcome [15] 376036 0
Carer distress assessed with the 21-item Depression, Anxiety and Stress Scale: DASS-21
Timepoint [15] 376036 0
1-week , 12-weeks, and 26-weeks post-intervention/control
Secondary outcome [16] 376041 0
Carer health expenditure will be assessed with a purpose designed incurred cost questionnaire that will document GP/mental health professional visits
Timepoint [16] 376041 0
1-week, 12-weeks, and 26 weeks post-intervention/control
Secondary outcome [17] 376048 0
Carer satisfaction with communication with the oncologist/nurse measured using a 25-item Consultation Satisfaction Scale.
Timepoint [17] 376048 0
1-week, 12-weeks, and 26 weeks post-intervention/control
Secondary outcome [18] 376049 0
Carer self-efficacy in interactions with the oncologist or nurse measured using the 5-item Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) questionnaire (Maly et al., 1998); with 3 additional items.
Timepoint [18] 376049 0
1-week, 12-weeks, and 26-weeks post-intervention/control
Secondary outcome [19] 376050 0
Carer preferences for their involvement in communication/decision-making, using 2 questions developed by Shin et al, 2013.
Timepoint [19] 376050 0
1-week, 12-weeks, and 26-weeks post-intervention/control
Secondary outcome [20] 376051 0
Patient preferences for the involvement of the carer in communication/decision-making, using 2 questions developed by Shin et al, 2013.
Timepoint [20] 376051 0
1-week, 12 weeks, and 26-weeks post-intervention/control

Eligibility
Key inclusion criteria
For clinicians:
• Hospital-based medical/radiation/surgical nurses and oncologists treating cancer patients.
• Nurses must have ongoing patient contact
• Have consultations with patients (and their family carers) to discuss cancer treatment
• Willing to participate in the study.
For patients:
• Aged over 18 years
• Diagnosed with cancer of any type
• Attending their first, second or third oncology consultation with a participating clinician
• Are accompanied to consultations by a family carer
• Having Internet access
• Willing to participate in the study.
For family carers:
• Are a person related to a participating patient biologically, legally, or emotionally who supports the patient inside and outside a consultation
• Aged over 18 years
• Having Internet access
• Willing to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For clinicians:
• In the case of doctors and nurses who work together within a site, either but not both may be recruited.

For patients:
• If their clinician considers them too unwell to participate
• If their family carer does not consent to participate in the study
• Insufficient English language skills to complete the intervention and/or questionnaires.

For family carers:
• If the patient for whom they are a carer does not consent to participate in the study
• Insufficient English language skills to complete the intervention and/or questionnaires.

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)
Allocation will be concealed for clinicians, as it will be done centrally by computer.
Patients and carers will be allocated to the intervention/control group based on the which group their treating clinician is allocated to (i.e. they will not be randomised).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done using a block randomisation table created by Microsoft Excel (i.e. computerised sequence generation). Only clinicians will be randomised, as patients and carers will be allocated to either the intervention/control group based on what group their treating clinician is allocated to. Randomisation will be stratified by profession (doctor or nurse).
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
Primary Outcomes:
Efficacy of the intervention (the eTRIO + eTRIO-pc modules) will be determined by changes in in-consultation carer relevant communication (using the KINcode coding system).. Potential confounders will be controlled for in all analyses (e.g. the length and type of the consultation).
Analyses will consist of a random effects linear regression model (i.e. mixed effects model) for clinicians with multiple patients. The random effect will account for multiple patients nested within each clinician.
Clinician type (oncologist/nurse), and its interaction with intervention group, will be coded and used as a predictor of the primary outcome.
We will control for patient/carer characteristics in the analysis (i.e. education, age, cancer type and stage).

Secondary Outcomes:
Will be examined using separate random effects regression models created for each outcome measure across testing points.
For the patient/carer outcome variables (i.e., self-efficacy, satisfaction, distress), clinician will be modelled as a random effect.

Feedback interview analysis:
The feedback interviews will be transcribed verbatim. Participants will be given the opportunity to member check their interview transcripts, to review and clarify their responses given in the interviews.
The researchers will then apply the Braun and Clarke (2006) method of thematic analysis to extract the themes from the qualitative data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2019
Actual
Date of last participant enrolment
Anticipated
31/03/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
676
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 14774 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 14775 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 14776 0
Westmead Hospital - Westmead
Recruitment hospital [4] 14777 0
Blacktown Hospital - Blacktown
Recruitment hospital [5] 14778 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [6] 14780 0
Mater Sydney - North Sydney
Recruitment hospital [7] 14781 0
St George Hospital - Kogarah
Recruitment hospital [8] 14783 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [9] 14784 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [10] 14788 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 28006 0
2139 - Concord
Recruitment postcode(s) [2] 28007 0
2050 - Camperdown
Recruitment postcode(s) [3] 28008 0
2145 - Westmead
Recruitment postcode(s) [4] 28009 0
2148 - Blacktown
Recruitment postcode(s) [5] 28010 0
2065 - St Leonards
Recruitment postcode(s) [6] 28012 0
2060 - North Sydney
Recruitment postcode(s) [7] 28013 0
2217 - Kogarah
Recruitment postcode(s) [8] 28015 0
6150 - Murdoch
Recruitment postcode(s) [9] 28029 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 303718 0
Government body
Name [1] 303718 0
Cancer Australia
Country [1] 303718 0
Australia
Funding source category [2] 303803 0
Charities/Societies/Foundations
Name [2] 303803 0
Cancer Council NSW
Country [2] 303803 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney,
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 303934 0
None
Name [1] 303934 0
Address [1] 303934 0
Country [1] 303934 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304243 0
Sydney Local Health District Human Research Ethics Committee – CRGH
Ethics committee address [1] 304243 0
Ethics committee country [1] 304243 0
Australia
Date submitted for ethics approval [1] 304243 0
06/05/2019
Approval date [1] 304243 0
06/08/2019
Ethics approval number [1] 304243 0
2019/ETH08715

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

Contacts
Principal investigator
Name 96258 0
A/Prof Ilona Juraskova
Address 96258 0
Brennan McCallum A18,
The University of Sydney, NSW 2006
Country 96258 0
Australia
Phone 96258 0
+61293516811
Fax 96258 0
Email 96258 0
ilona.juraskova@sydney.edu.au
Contact person for public queries
Name 96259 0
Rebekah Laidsaar-Powell
Address 96259 0
Level 6 Chris O’Brien Lifehouse (C39Z),
The University of Sydney,
NSW 2006
Country 96259 0
Australia
Phone 96259 0
+61 286275315
Fax 96259 0
Email 96259 0
rebekah.laidsaar-powell@sydney.edu.au
Contact person for scientific queries
Name 96260 0
Rebekah Laidsaar-Powell
Address 96260 0
Level 6 Chris O’Brien Lifehouse (C39Z),
The University of Sydney,
NSW 2006
Country 96260 0
Australia
Phone 96260 0
+61 286275315
Fax 96260 0
Email 96260 0
rebekah.laidsaar-powell@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


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
EmbaseETRIO trial: Study protocol of a randomised controlled trial of online education modules to facilitate effective family caregiver involvement in oncology.2021https://dx.doi.org/10.1136/bmjopen-2020-043224
N.B. These documents automatically identified may not have been verified by the study sponsor.