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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]

None

Universal Trial Number (UTN)

Trial acronym

SecondEars

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cancer

Condition category

Condition code

Cancer

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]

Behaviour

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Identification of barriers and enablers for clinical implementation

Timepoint [1]

Follow-up interview one week post intervention delivery

Secondary outcome [1]

Patient satisfaction assessed through custom qualitative interview

Timepoint [1]

one week post intervention delivery

Secondary outcome [2]

Clinician barriers to app implementation via custom quantitative survey

Timepoint [2]

at completion of trial recruitment

Secondary outcome [3]

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]

One week post intervention delivery

Secondary outcome [4]

Clinician enablers to app implementation in a clinical setting via custom quantitative survey

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Peter MacCallum Cancer Centre - Melbourne

Recruitment postcode(s) [1]

3000 - Melbourne

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Victorian Managed Insurance Authority

Address [1]

161 Collins St, Melbourne VIC 3000

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Peter MacCallum Foundation

Address [2]

305 Grattan Street Parkville Melbourne Victoria 3000

Country [2]

Australia

Primary sponsor type

Hospital

Name

Peter MacCallum Cancer Centre

Address

305 Grattan Street Parkville Melbourne Victoria 3000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peter MacCallum Cancer Centre

Ethics committee address [1]

305 Grattan Street Parkville Melbourne Victoria 3000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/02/2016

Approval date [1]

03/04/2017

Ethics approval number [1]

LNR/16/PMCC/11

Summary

Brief summary

This study concerns the development and testing of a mobile phone application for the audio recording of oncology consultations.

Who is it for?
You may be eligible for this study if you are a cancer consumer or staff member at the Peter MacCallum Cancer Centre.

Study details
You may be invited to try a new consultation audio-recording app during your next consultation at Peter MacCallum Cancer Centre. An ‘app’ is a program that you can use on a mobile phone or tablet device. 

Patients who decide to take part, will be asked to audio-record their next consultation using the app.  A copy of the audio-recording will also be kept and securely stored at Peter Mac. For those patients who decide to take part, any family members or friends who accompany them to your hospital consultation will be asked whether they are happy to be audio-recorded by the app during the consultation. . 

People who decide to take part in this study will be contacted one week after their audio-recorded consultation to complete in a telephone survey (30 minutes) to discuss what they think about the audio-recording app. We will audio-record this interview so that we can listen back over your answers and combine them with everyone else’s to get our results. The audio-recording of the telephone interview will be stored for 5 years post study completion. There are no costs associated with participating in this research project, nor will you be paid. 

It is hoped this research will contribute to the implementation of the audio recording app at Peter Mac. Oncology consultations contain a lot of information, and patients and their family members/friends may be very anxious while at the hospital, which makes it hard to remember everything that is discussed in the consultation. We hope that having an easy to use audio-recording app will be helpful for patients and their family members/friends by allowing them to re-listen to the consultation at their convenience. 

We have designed this app with help from people like you, and now we would like to try using the app in a health care setting. We are looking at how best to use the app in the hospital, and so we are seeking feedback from patients and health care professionals.

Trial website

N/A

Trial related presentations / publications

n/a

Public notes

Contacts

Principal investigator

Name

Ms Amelia Hyatt

Address

Peter MacCallum Cancer Centre
305 Grattan st Parkville Melbourne Victoria 3000

Country

Australia

Phone

+61385597837

Fax

[email protected]

Contact person for public queries

Name

Amelia Hyatt

Address

Peter MacCallum Cancer Centre
305 Grattan st Parkville Melbourne Victoria 3000

Country

Australia

Phone

+61385597837

Fax

[email protected]

Contact person for scientific queries

Name

Amelia Hyatt

Address

Peter MacCallum Cancer Centre
305 Grattan st Parkville Melbourne Victoria 3000

Country

Australia

Phone

+61385597837

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Attachment
2061	Study protocol	373915-(Uploaded-13-05-2019-15-48-14)-Study-related document.docx
2066	Informed consent form	373915-(Uploaded-13-05-2019-10-23-01)-Study-related document.doc
2068	Ethical 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

Source	Title	Year of Publication	DOI
Embase	Testing Consultation Recordings in a Clinical Setting With the SecondEars Smartphone App: Mixed Methods Implementation Study.	2020	https://dx.doi.org/10.2196/15593

N.B. These documents automatically identified may not have been verified by the study sponsor.

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