ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12624000585527

Ethics application status

Approved

Date submitted

28/03/2024

Date registered

8/05/2024

Date last updated

8/05/2024

Date data sharing statement initially provided

8/05/2024

Type of registration

Retrospectively registered

Titles & IDs

Public title

Telehealth vs face-to-face consults in patients attending a Urological Oncology Clinic. A Randomised Controlled Trial.

Scientific title

Telehealth vs face-to-face consults in patients attending a Urological Oncology Clinic. A Randomised Controlled Trial.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Telehealth in Urological Oncology

urological cancer

Condition category

Condition code

Public Health

Health service research

Cancer

Bladder

Cancer

Kidney

Cancer

Prostate

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention in this trial would be randomising patients (already known to the Crown Princess Mary Cancer Centre) in 1 of 2 study arms to a Telehealth consultation as the mode of consult for their next follow up appointment. This Telehealth appointment will be carried out via telephone calls during a booked in clinic appointment time. Patients data including name, DOB and MRN are collected from a third party offsite investigator utilising the hospitals booking system. Eligible patients will be contacted and the trial discussed with them, if they are agreeable, a patient information and consent form will be posted/emailed to the patients. Once consent is obtained, randomisation occurs using an online web-based generator. Patients are then informed of their allocation 24 hours prior to their next follow up appointment over the phone. For the clinicians providing the care, patients allocation will be placed in opaque sealed envelopes that the clinician will obtain just prior to each patients appointment time slot. Following this, patients either randomised to Telehealth or face-to-face will complete a validated questionnaire, delivered either online via a survey monkey link or a hard copy, respectively.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The Standard face-to-face consultations are the comparator/control for the purposes of this study and represent 1/2 study arms against which telehealths effectiveness will be compared via the use of validated questionnaires. Given the mode of delivery for each consultation at the Crown Princess Mary Cancer Centre in Westmead Hospital is conducted via face-to-face appointments in the urological oncology clinics, this will serve as a valid control group to compare the effectiveness of Telehealth via questionnaire responses against those completed by patients randomised to the standard face-to-face approach.

Control group

Placebo

Outcomes

Primary outcome [1]

Patient satisfaction survey scores regarding Telehealth vs standard face-to-face consultation

Timepoint [1]

Following next follow up appointment (usually occurring 2 weeks post enrolment) , patients randomised to the Telehealth group will be emailed a survey monkey link to their nominated email address the very same day. Approximately 2 weeks is given for responses, with reminders sent out at week 3 and week 4. For patients randomised to the face-to-face group: hard copies of the questionnaires are provided by reception staff at the conclusion of the appointment and placed in a tray at the reception desk prior to patients departing the clinic.

Secondary outcome [1]

Patient assessment of the services provided (RFA bookings, investigations, follow up of results) with regards to either face-to-face or Telehealth consultations

Timepoint [1]

Telehealth Study Arm: 2 weeks will be given following the email of the Survey Monkey Link (sent out on day of appointment) of the validated questionnaires. At week 3 and 4: reminder text messages will be sent out.
Face to Face study arm: not applicable as validated questionnaires will be provided in hard copy follow their appointment and collected in a tray available on the clinic reception desk prior to the patients exiting the clinic.

Eligibility

Key inclusion criteria

All patients within the clinic who require ongoing follow up.
No history of baseline confusion/severe cognitive impairment unless a carer is available to assist with telephone appointment.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

New or initial referrals
History of non-compliance (multiple prior non-attendances to appointments in the past).
NESB (Non-English-Speaking-Background).
Patients who declined randomisation.
General outpatient or non-urological oncology clinics.

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)

Randomised via a web based computer generator and allocation concealed via sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

computer sequence generation

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

13/02/2023

Date of last participant enrolment

Anticipated

Actual

7/09/2023

Date of last data collection

Anticipated

Actual

22/09/2023

Sample size

Target

126

Accrual to date

Final

116

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Westmead Hospital - Westmead

Recruitment postcode(s) [1]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Westmead Hospital, Western Sydney Local Health District

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

David Armany

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

https://www.wslhd.health.nsw.gov.au/Education-Portal/Research/ethics-governance

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/08/2022

Approval date [1]

09/09/2022

Ethics approval number [1]

Summary

Brief summary

This is a study that will be used to evaluate how effective Telehealth is for patients who are already being followed up in a urological oncology clinic. You may be eligible for this study if you are already a patient who is regularly followed up at the Crown Princess Mary Cancer Centre in Westmead Hospital for a urological cancer condition. Unfortunately, if you are not yet known to the clinic or are awaiting to see a urologist for your first visit, you will not be eligible to participate. 

Study Details
Patients who are eligible for the study will be contacted and informed about the trials aims and methods and informed consent will need to be provided should they wish to participate. Following this, participants will be randomised prior to their next follow up appointment to either a Telehealth group or the standard face-to-face appointment type. They will be notified of their allocation 24 hours prior to their appointment. At the end of the follow up appointment, participants will be asked to completed a validated questionnaire that will help quantify their responses with regards to effectiveness, services provided, efficiency and timing of the appointment, and overall satisfaction. These scores will be de-identified and anonymous. 

By participating in this trial, we will be able to compare how effective patients find Telehealth vs face-to-face consultations for those suffering from common urological malignancies. We also will assess to see if there are any barriers to the widespread adoption of Telehealth for these common health conditions and if any adverse effects are encountered. This knowledge can help potentiate Telehealth's adaptation to other fields of surgical and medical disciplines as well as providing timely and more efficient care to a greater number of patients within the local health district.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr David Armany

Address

Crown Princess Mary Cancer Centre, Westmead Hospital: Corner Hawkesbury Road and Darch Road, Westmead NSW 2145

Country

Australia

Phone

+61 449984903

Fax

David.armany@health.nsw.gov.au

Contact person for public queries

Name

David Armany

Address

Crown Princess Mary Cancer Centre, Westmead Hospital: Corner Hawkesbury Road and Darch Road, Westmead NSW 2145

Country

Australia

Phone

+61 449984903

Fax

David.armany@health.nsw.gov.au

Contact person for scientific queries

Name

David Armany

Address

Crown Princess Mary Cancer Centre, Westmead Hospital: Corner Hawkesbury Road and Darch Road, Westmead NSW 2145

Country

Australia

Phone

+61 449984903

Fax

David.armany@health.nsw.gov.au

Data sharing statement

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

Yes

What data in particular will be shared?

survey scores

When will data be available (start and end dates)?

Data is available immediately and available for 5 years.

Available to whom?

upon request to any government body or journal

Available for what types of analyses?

only to achieve the aims in the approved proposal

How or where can data be obtained?

access subject to approvals by Principal Investigator (Davidarmany72@gmail.com)

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
22011	Study protocol			davidarmany72@gmail.com		387590-(Uploaded-28-03-2024-15-52-25)-Study-related document.docx

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.

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