Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000730202
Ethics application status
Approved
Date submitted
26/04/2018
Date registered
2/05/2018
Date last updated
13/05/2019
Date data sharing statement initially provided
13/05/2019
Date results provided
13/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Second Ears: Development and clinical testing of an app for audio-recording hospital consultations for oncology patients to identify barriers and facilitators for clinical implementation
Scientific title
Development and clinical testing of an app for audio-recording hospital consultations for oncology patients.
Secondary ID [1] 293260 0
None
Universal Trial Number (UTN)
Trial acronym
SecondEars
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 307602 0
Condition category
Condition code
Cancer 306659 306659 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
the intervention comprises the use of the SecondEars smartphone application to audio-record 1 x key medical consultation per patient. Eligible patients are contacted prior to attending their appointment. After providing informed consent, information is provided on how to download, install, and login to SecondEars. The study team confirms on arrival that the app is downloaded and installed correctly. Attending family members and treating clinician also provide informed consent as the consultation is audio-recorded.
A follow-up interview will be conducted with patients one week after intervention delivery. At the follow-up interviews patients will be asked about app use (adherence). Participants are not required to listen to the audio-recording, however this will be assessed as part of the follow-up interview. They are able to download a copy of the audio-recording to keep permanently, however the app will be removed from their smartphone approximately 2 weeks post consultation. Backend app analytics through iTunes provide quantifiable records of app use. Clinical surveys also provide data to triangulate app use and adherence, and will be distributed to clinical staff at the conclusion of the study.
Intervention code [1] 301015 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305665 0
Identification of barriers and enablers for clinical implementation
Timepoint [1] 305665 0
Follow-up interview one week post intervention delivery
Secondary outcome [1] 346103 0
Patient satisfaction assessed through custom qualitative interview
Timepoint [1] 346103 0
one week post intervention delivery
Secondary outcome [2] 346160 0
Clinician barriers to app implementation via custom quantitative survey
Timepoint [2] 346160 0
at completion of trial recruitment
Secondary outcome [3] 346162 0
Patient assessment of app design via the first two sub-scales (aesthetics and functionality) the Mobile Phone Rating scale, validated measure - composite secondary outcome
Timepoint [3] 346162 0
One week post intervention delivery
Secondary outcome [4] 346246 0
Clinician enablers to app implementation in a clinical setting via custom quantitative survey
Timepoint [4] 346246 0
quantitative survey at completion of project

Eligibility
Key inclusion criteria
Eligibility Criteria - patients
- Cancer Consumer on the Peter Mac Consumer Registry
- Able to read write and speak English

The study will aim to recruit a total of 10 cancer consumers to attend the workshop

Eligibility criteria:- clinical staff
- Working at Peter Mac in one of the following roles: oncologist, nurse, allied health, volunteer, health information management or IT

This study will aim to recruit a representative from one of the above roles listed.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
not owning an iphone
too unwell

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)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be generated from the clinician and oncology patient structured surveys. Descriptive statistics (counts/percentages, means/standard deviations or medians/inter-quartile ranges, as appropriate) will be used to summarise patient demographic and clinical characteristics and survey responses (this will include a summary of missing items and forms).Clinician demographic characteristics and survey responses will be summarised in the same manner.

Qualitative survey data
Qualitative survey questions which elicit qualitative responses will be analysed using interpretive description. Transcribed data will be sorted into codes, then categories and themes, according to clinical utility. Analysis will be conducted using NVIVO.

Quantitative survey data
Quantitative Survey items (MARS) for the first two sub-scales (aesthetics and functionality) will be summed to generate mean scores for each participant, with these aggregated and reported using descriptive statistics. The final scale (subjective app use) items will be described independently (again using descriptive statistics stated above), as per recommendations by the MARS developers (1). Data will be analysed using appropriate statistical software.

App analytics
Anonymised user data will be collected by the app regarding user actions. This will be aggregated and exported as numerical counts and percentages. Data will be further aggregated and described descriptively where required.

1. Stoyanov SR, Hides L, Kavanagh DJ, Zelenko O, Tjondronegoro D, Mani M. Mobile app rating scale: a new tool for assessing the quality of health mobile apps. JMIR mHealth and uHealth. 2015;3(1

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/03/2018
Date of last participant enrolment
Anticipated
8/06/2018
Actual
2/08/2018
Date of last data collection
Anticipated
15/06/2018
Actual
8/08/2018
Sample size
Target
21
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10790 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 22529 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 297889 0
Government body
Name [1] 297889 0
Victorian Managed Insurance Authority
Country [1] 297889 0
Australia
Funding source category [2] 299331 0
Charities/Societies/Foundations
Name [2] 299331 0
Peter MacCallum Foundation
Country [2] 299331 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan Street Parkville Melbourne Victoria 3000
Country
Australia
Secondary sponsor category [1] 296942 0
None
Name [1] 296942 0
Address [1] 296942 0
Country [1] 296942 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298938 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 298938 0
Ethics committee country [1] 298938 0
Australia
Date submitted for ethics approval [1] 298938 0
08/02/2016
Approval date [1] 298938 0
03/04/2017
Ethics approval number [1] 298938 0
LNR/16/PMCC/11

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

Contacts
Principal investigator
Name 78718 0
Ms Amelia Hyatt
Address 78718 0
Peter MacCallum Cancer Centre
305 Grattan st Parkville Melbourne Victoria 3000
Country 78718 0
Australia
Phone 78718 0
+61385597837
Fax 78718 0
Email 78718 0
[email protected]
Contact person for public queries
Name 78719 0
Amelia Hyatt
Address 78719 0
Peter MacCallum Cancer Centre
305 Grattan st Parkville Melbourne Victoria 3000
Country 78719 0
Australia
Phone 78719 0
+61385597837
Fax 78719 0
Email 78719 0
[email protected]
Contact person for scientific queries
Name 78720 0
Amelia Hyatt
Address 78720 0
Peter MacCallum Cancer Centre
305 Grattan st Parkville Melbourne Victoria 3000
Country 78720 0
Australia
Phone 78720 0
+61385597837
Fax 78720 0
Email 78720 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patients did not give consent for data sharing at the time of recruitment.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2061Study protocol    373915-(Uploaded-13-05-2019-15-48-14)-Study-related document.docx
2066Informed consent form    373915-(Uploaded-13-05-2019-10-23-01)-Study-related document.doc
2068Ethical approval    373915-(Uploaded-13-05-2019-10-23-29)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTesting Consultation Recordings in a Clinical Setting With the SecondEars Smartphone App: Mixed Methods Implementation Study.2020https://dx.doi.org/10.2196/15593
N.B. These documents automatically identified may not have been verified by the study sponsor.