We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620001167954p
Ethics application status
Submitted, not yet approved
Date submitted
30/10/2020
Date registered
6/11/2020
Date last updated
17/12/2020
Date data sharing statement initially provided
6/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Melanoma Patients’ and Clinicians’ Satisfaction with Telehealth During COVID-19
Scientific title
Melanoma Patients’ and Clinicians’ Satisfaction with Telehealth During COVID-19
Secondary ID [1] 302657 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 319565 0
Condition category
Condition code
Cancer 317511 317511 0 0
Malignant melanoma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is interested in exploring melanoma patients' and clinicians' satisfaction with telehealth that they received during COVID-19 pandemic as well as factors that may be associated with this satisfaction.

Patients will be required to complete one 20-minute survey. Patients will self-select to participate in the study and can choose whether this survey is completed in the paper form, or online (via REDCap). For online completion, the patients will be required to complete the survey in one sitting. Patient survey will contain demographic (birth year, gender, living arrangements, language spoken at home, health insurance status, employment status, highest educational attainment, postcode of primary residence, annual income) and clinical (time since diagnosis, melanoma stage, past and current treatments for melanoma, current melanoma status) questions, information about telehealth received (when was the most recent telehealth consultation, type of telehealth, whether it was a part of clinical trial), the measure of their satisfaction with telehealth they received during COVID-19 (Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ), additional Likert and qualitative questions), trust in oncologist (Trust in Oncologist Scale (TiOS-SF)), quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Melanoma Concerns Questionnaire (MCQ-28)), Fear of Cancer Recurrence (Fear of Cancer Recurrence Short Form Inventory (FCRI-SF)).

Clinicians will also self-select to participate in this study. They will be required to answer one 10 minute survey containing demographic (birth year, gender) and professional (profession/specialisation, career stage, years working in melanoma), information about most recent telehealth consultation provided (month of this consultation, mode of delivery, whether it was a part of a clinical trial), information about the adequacy of MBS item numbers for telehealth, measurement of satisfaction with telehealth (Health Optimum Telemedicine Acceptance Questionnaire, additional Likert and qualitative questions)
Intervention code [1] 318944 0
Not applicable
Comparator / control treatment
No control group as observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325548 0
Patients' satisfaction with telehealth, which is a composite primary outcome, measured by:
- Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ)
- 4 additional satisfaction questions that have been previously used in research
- 5 satisfaction qualitative questions that will be analysed for emerging themes
Timepoint [1] 325548 0
At the time of survey completion
Primary outcome [2] 325549 0
Clinicians' satisfaction with telehealth, which is a composite primary outcome, as measured by:
- Health Optimum Telemedicine Acceptance Questionnaire
- Additional 9 quantitative satisfaction questions previously used in research
- five qualitative questions that will be analysed for emerging themes
Timepoint [2] 325549 0
At the time of survey completion
Secondary outcome [1] 388359 0
Trust in oncologist, measured using Trust in Oncologist Scale (TiOS-SF)
Timepoint [1] 388359 0
At the time of survey completion
Secondary outcome [2] 388404 0
- Quality of life, measured using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3 (EORTC QLQ-C30) and Melanoma Concerns Questionnaire (MCQ-28)
Timepoint [2] 388404 0
At the time of survey completion
Secondary outcome [3] 388405 0
- Fear of Cancer Recurrence, measured using Fear of Cancer Recurrence Inventory- Short Form (FCRI-SF)
Timepoint [3] 388405 0
At the time of survey completion
Secondary outcome [4] 388553 0
Suitability of Medicare items for telehealth consultations in melanoma, as measured by 4 qualitative questions that have been designed specifically for this study
Timepoint [4] 388553 0
At the time of survey completion

Eligibility
Key inclusion criteria
Patients:
- 18 years of age.
- Able to read and understand English and respond to study questions
- Cognitive capacity to provide informed consent.
- Diagnosis of melanoma (any stage).
- Participation in at least on telehealth consultation in relation to their melanoma since March 2020.
- Receiving services from healthcare professionals at one of the study sites.

Clinicians
- Healthcare professional (e.g. doctor, nurse, allied health) involved in providing care, support, and management of patients with melanoma.
- Providing services within the study sites that are approved for this study.
- Provision of at least one telehealth consultation in relation to melanoma management since March 2020.

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients:
- Younger than 18 years of age.
- Insufficient English and/or cognitive ability to understand and respond to study materials.
- Diagnosis of any other skin condition, including non-melanoma skin cancer
- Participation in telehealth. consultations that are not related to melanoma management.

Clinicians
- Practicing outside the approved study sites.
- Providing only face to face consultations during COVID-19 (since March 2020)
- Not involved in care of melanoma patients.
- Participation in an interview as a part of ‘The Management of Primary Melanoma in the Time of COVID-19; Lessons and Future Directions’


Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
To have an adequate power for this study (80%) to detect a significant (p<0.05) small-moderate effect of demographic, clinical and psychological variables on telehealth satisfaction, this study needs 80 participants. To account for missing / incomplete surveys, this study will aim to recruit at least 100 participants.

Demographist information will be described using central tendency measures (continuous data) and frequency counts (categorical data).

- Satisfaction with tele-health will be assessed using Mean scores (SD) for continuous questionnaire scores. Additionally, the frequency of Likert-type responses will be calculated, and it was decided a-priori that patients and clinicians will be classified as reporting high satisfaction if their scores are 4-5 on each question.
- two tailed independent samples t-test will be used to determine whether satisfaction depends on whether telehealth was provided by video or telephone
- To determine suitability of Medicare items for telehealth, thematic analysis of qualitative clinician responses will be used
- To determine whether telehealth improves access to patients from rural/remote regions and those of lower socio-economic status, independent samples t-test will be used, with patients grouped as either from urban or rural/remote areas and earning less than $62,000 per annum and those earning more than this amount.
- To outline the benefits / concerns about telehealth raised by patients and clinicians, thematic analysis of qualitative answers will be conducted as well as identification of most highly / lowly rated items on TSUQ, additional satisfaction questions
- to determined factors associated with telehealth satisfaction, regression analysis of TSUQ scores with clinical, quality of life and psychological variables will be conducted.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17915 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 17916 0
The Poche Centre, Melanoma Institute Australia - North Sydney
Recruitment postcode(s) [1] 31778 0
2050 - Camperdown
Recruitment postcode(s) [2] 31779 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 307094 0
Charities/Societies/Foundations
Name [1] 307094 0
Melanoma Institute Australia
Address [1] 307094 0
40 Rocklands Road
Wollstonecraft NSW 2067
Country [1] 307094 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Melanoma Institute Australia
Address
40 Rocklands Road
Wollstonecraft NSW 2067
Country
Australia
Secondary sponsor category [1] 307665 0
None
Name [1] 307665 0
Address [1] 307665 0
Country [1] 307665 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307211 0
Royal Prince Alfred Hospital HREC
Ethics committee address [1] 307211 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
CAMPERDOWN NSW 2050
Ethics committee country [1] 307211 0
Australia
Date submitted for ethics approval [1] 307211 0
21/09/2020
Approval date [1] 307211 0
05/11/2020
Ethics approval number [1] 307211 0
2020/ETH02519

Summary
Brief summary
During the COVID-19 Pandemic a number of medical and allied health consultations has been changed from face-to-face to telehealth, using either telephone or video. This study would like to understand the level of satisfaction melanoma patients and their clinicians had with telehealth. Learning about the satisfaction may lead to improvement of this service in the future, as telehealth may be able to bridge geographical gaps many patients experience who do not live in large urban areas.

Who is this study for?
Patients:
This study may be suitable for you if you are: at least 18 years of age, able to read and understand English and respond to survey questions, are able to provide informed consent, you have been diagnosed with melanoma, you have had at least one consultation via telehealth since March 2020, you are receiving services from healthcare professionals at Melanoma Institute Australia, or Melanoma and Surgical Oncology at Royal Prince Alfred Hospital

Clinicians:
This study may be suitable for you if you are: a healthcare professional (e.g. doctor, nurse, allied health) involved in providing care, support, and management of patients with melanoma, providing services at Melanoma Institute Australia and Royal Prince Alfred Hospital, you have provided at least one telehealth consultation in relation to melanoma management since March 2020.

Study details:
Participants enrolled in this study will be asked to complete ONE survey. Melanoma patients will be able to complete this survey online or in paper form. This survey will take about 20 minutes to complete and will contain questions about general demographic and melanoma information, satisfaction with telehealth, emotional and physical functioning, Clinicians will, be asked to complete a 10 minute survey containing questions about their general demographic information, their career stage, opinion about adequacy of Medicare items for telehealth as well as their own perception of telehealth they provided. Clinician survey will be available online.

It is hoped that this study will highlight the benefits of telehealth, as well as some areas where improvements may be needed. This may lead to implementation of the strategies to address areas of low satisfaction in both clinical practice as well as research.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106418 0
Dr Iris Bartula
Address 106418 0
Melanoma Institute Australia
Poche Centre
40 Rocklands Road,
Wollstonecraft NSW 2065
Country 106418 0
Australia
Phone 106418 0
+61 2 9911 7398
Fax 106418 0
Email 106418 0
iris.bartula@melanoma.org.au
Contact person for public queries
Name 106419 0
Dr Iris Bartula
Address 106419 0
Melanoma Institute Australia
Poche Centre
40 Rocklands Road,
Wollstonecraft NSW 2065
Country 106419 0
Australia
Phone 106419 0
+61 2 9911 7398
Fax 106419 0
Email 106419 0
iris.bartula@melanoma.org.au
Contact person for scientific queries
Name 106420 0
Dr Iris Bartula
Address 106420 0
Melanoma Institute Australia
Poche Centre
40 Rocklands Road,
Wollstonecraft NSW 2065
Country 106420 0
Australia
Phone 106420 0
+61 2 9911 7398
Fax 106420 0
Email 106420 0
iris.bartula@melanoma.org.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?
Any data shared will be anonymous - containing only demographic information about the participants. Patients are unlikely to be identified by this demographic information. Clinician's data is potentially identifiable. As a preference, demographic data for the clinicians will be shared in a group format, or separated from the survey responses, to protect the clinician’s privacy.
When will data be available (start and end dates)?
Following publication of primary outcomes from this study - no end date
Available to whom?
To other researchers who present methodologically-sound, Human Research Ethics Committee-approved research plan/protocol to Dr Bartula who will be the guardian of the data.
Available for what types of analyses?
Only to achieve the aims of the proposal that has been presented when data sharing was agreed to.
How or where can data be obtained?
Access subject to approval by Dr Bartula
Address: 40 Rocklands Road Wollstonecraft NSW 2065 Australia
Phone: +612 9911 7398
Email: iris.bartula@melanoma.org.au

relevant files will be emailed upon access to data being granted.
What supporting documents are/will be available?
Study protocol
Other
'Other' documents specified
Data Dictionary
How or where can supporting documents be obtained?
Type [1] 9574 0
Study protocol
Citation [1] 9574 0
Link [1] 9574 0
Email [1] 9574 0
iris.bartula@melanoma.org.au
Other [1] 9574 0
Attachment [1] 9574 0
Type [2] 9575 0
Other
Citation [2] 9575 0
Link [2] 9575 0
Email [2] 9575 0
iris.bartula@melanoma.org.au
Other [2] 9575 0
Attachment [2] 9575 0
Summary results
No Results