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Trial registered on ANZCTR


Registration number
ACTRN12620000686909p
Ethics application status
Submitted, not yet approved
Date submitted
27/03/2020
Date registered
17/06/2020
Date last updated
17/06/2020
Date data sharing statement initially provided
17/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The iScreen Study. Developing and evaluating a web-based portal to screen for Patient Reported Outcomes in cancer.
Scientific title
The iScreen Study. Developing and evaluating a web-based portal to screen for Patient Reported Outcomes in cancer.
Secondary ID [1] 300688 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer, unmet needs 316531 0
Condition category
Condition code
Cancer 314776 314776 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention that is being investigated for feasibility, acceptability, cost and safety is the iScreen system. This is a web-based portal that collects patient reported outcomes in order to identify and address unmet needs. Health care providers (any FMC staff that are involved in the care of cancer patients) will be trained (face-to-face and provided with a user guide) how to register patients into the iScreen system and direct them to complete the survey of patient report outcomes. The survey is called the Edmonton Symptom Assessment Scale, which takes approximately 10 minutes to complete. Patients will complete the questionnaire either at home (provided with a link to the portal) or with the health care provider at the time of enrolment. After the survey is completed, the health care provider and patient will receive a summary of their unmet needs (staff will receive a notification that one of their patients has an identified need). Staff will then determine appropriate management so as to resolve/reduce needs. The iScreen portal will provide suggestions to the nurse for how to manage the unmet need according to level of need identified. This will be based on evidence based algorithms developed by Cancer Care Ontario - which describe how a patient with a particular need should be managed (e.g. by referring to a specialist, by receiving educational materials or by the scheduling of a clinical appointment). Educational resources will also be accessible to the patient within the portal via links. These resources will be Australian-based and provide information about what a patient can do to meet their need. The use of the ESAS to collect Patient reported outcomes is already established as best practice. Therefore the aim of this project is to determine the acceptability and feasibility of the implementation of the iScreen system as the mechanism to implement the ESAS and to manage patient's needs. The acceptance and feasibility will be assessed by survey/focus group or interview with patients and staff, and via analysing the metrics of the iScreen system (i.e. number of patients enrolled, appropriate follow up etc).


Intervention code [1] 317036 0
Early detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323134 0
Acceptability: the quality of the tolerability and acceptability of the system from the perspective of the staff and patients.
Measured by:
1. A survey developed specifically for the purposes of this study (all patients and staff that have been involved in the administration of the system will be eligible to complete the survey, no more than 2 pages in length and will take no more than 10 minutes to complete); and
2. Either an interview or focus group (All patients and staff that have been involved in the administration of the system will be eligible for an open-ended interview/focus group. The focus group/interview will take no longer than 45 minutes and each participant will only participate in one interview/focus group. The semi-structured interviews/focus groups will be audio recorded and transcribed, guided by a topic guide, and findings will be analysed through coding and the identification of themes); and
3. The metrics collected by the iScreen system will also be evaluated: i.e. the number of participants that are enrolled and the number that are referred/provided care.

This is a composite primary outcome. All patients and staff members will be potential participants. Recruitment of participants will continue until data saturation is achieved.
Timepoint [1] 323134 0
at 3 months from initial (baseline) screen
Secondary outcome [1] 380901 0
Cost: a comparison of the cost of implementing the iScreen system (calculated by considering time taken logged into iScreen system multiplied by staff salary cost) will be compared to cost (the amount of time x salary cost) that staff usually spend in identifying and managed patient's unmet needs.
Timepoint [1] 380901 0
This will be measured after the implementation of the study.
Secondary outcome [2] 380904 0
Feasibility: whether the system can be easily or conveniently implemented (by patient and staff). Measured by:
1. A survey developed specifically for the purposes of this study (all patients and staff that have been involved in the administration of the system will be eligible to complete the survey, no more than 2 pages in length and will take no more than 10 minutes to complete); and
2. Either an interview or focus group (All patients and staff that have been involved in the administration of the system will be eligible for an open-ended interview/focus group. The focus group/interview will take no longer than 45 minutes and each participant will only participate in one interview/focus group. The semi-structured interviews/focus groups will be audio recorded and transcribed, guided by a topic guide, and findings will be analysed through coding and the identification of themes); and
3. The metrics collected by the iScreen system will also be evaluated: i.e. the number of participants that are enrolled and the number that are referred/provided care.
Timepoint [2] 380904 0
Participants will engage in qualitative interviews and complete a survey at least 3 months after their first use of the system.
Secondary outcome [3] 380907 0
Safety: an adverse events register will be available for staff to record any adverse events that occur during implementation of the system. A staff member will enter information about any adverse events that arise during the implementation of the system. They will be issues that are noticed by the staff member, or reported to the staff member by patients involved. An example of adverse events would be: a patient becomes distressed because they have not received expected follow up from nurse after completing the ESAS survey. Likewise, a patient may expect that they receive some follow up as a result of their participation in the portal and not take other measures (that they would normally have if they hadn't completed the ESAS) to address their need. This could lead to distress or a worsening of symptoms. However, these are both unlikely, given that the messages provided to patients in the portal will clearly indicate what they can expect to happen now they have completed the survey, and direct them to care options including calling an ambulance or attending the emergency room at their nearest hospital, if their need is urgent.
Timepoint [3] 380907 0
Will continue to be assessed throughout the 16 month implementation period.

Eligibility
Key inclusion criteria
Patients:
* Diagnosed with any type of cancer;
• Receives care from any Flinders Medical Centre (FMC) cancer care service; and
• Is able to participate in a focus group or interview or complete a questionnaire.
• Able to communicate effectively for participation in data collection.

Staff:
• Provides clinical care to patients with any type of cancer as nurse, medical practitioner or administrative staff; and
• Employed by SALHN in any FMC Cancer Service, and work in the Service regularly, e.g. locums.

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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)
Safety/efficacy
Statistical methods / analysis
Quantitative data will be analysed using descriptive statistics (mean and standard deviation for normally distributed variables; median and IQR for data that is not normally distributed). Qualitative data will be analysed using nVivo to code data, then to identify themes that summarise the data collected.

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)
SA
Recruitment hospital [1] 16059 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 29571 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 305132 0
Charities/Societies/Foundations
Name [1] 305132 0
The Hospital Research Foundation
Address [1] 305132 0
60 Woodville Rd, Woodville SA 5011
Country [1] 305132 0
Australia
Primary sponsor type
University
Name
Flinders Cancer Research, Flinders University
Address
Flinders University
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 305523 0
None
Name [1] 305523 0
none
Address [1] 305523 0
none
Country [1] 305523 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305502 0
Southern Adelaide Committee: Human Research Ethics Committee
Ethics committee address [1] 305502 0
Ward 6C, Room 6A219
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 305502 0
Australia
Date submitted for ethics approval [1] 305502 0
27/05/2020
Approval date [1] 305502 0
Ethics approval number [1] 305502 0

Summary
Brief summary
STUDY AIM
This study will evaluate the feasibility of a web-based system of patient reported outcomes (PROs) assessment to identify and address unmet needs of cancer patients.

WHO IS IT FOR?
Patients: You may be eligible to join this study if you are aged 18 years or more, and have been diagnosed with any type of cancer for which you are receiving care from Flinders Medical Centre.
Staff: You may be eligible to join this study if you are employed by Flinders Medical Centre and provide care for patients with cancer.

STUDY DETAILS:
Patients and staff participants in this study will provide feedback via a survey and interview or focus group regarding their experience using a web-based portal, called iScreen, to provide PRO data.

Patients will be asked to engage in qualitative interviews and complete a survey at least 3 months after their first use of the system to indicate its acceptability. Data on feasibility, cost and safety will also be collected throughout the 16 month implementation period.

It is hoped that results from this study will indicate that the iScreen system is feasible, safe and acceptable. It is anticipated that further funding will be sought in order to evaluate the effectiveness of the system and to ultimately roll out the system permanently within Flinders Medical Centre and perhaps across other health institutions.
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 100586 0
Prof Bogda Koczwara
Address 100586 0
Level 4 North,
Flinders Centre for Innovation in Cancer

Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042
Country 100586 0
Australia
Phone 100586 0
+61882048997
Fax 100586 0
Email 100586 0
bogda.koczwara@flinders.edu.au
Contact person for public queries
Name 100587 0
Prof Bogda Koczwara
Address 100587 0
Level 4 North,
Flinders Centre for Innovation in Cancer

Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042
Country 100587 0
Australia
Phone 100587 0
+61 8 8204 8997
Fax 100587 0
Email 100587 0
bogda.koczwara@flinders.edu.au
Contact person for scientific queries
Name 100588 0
Prof Bogda Koczwara
Address 100588 0
Level 4 North,
Flinders Centre for Innovation in Cancer

Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042
Country 100588 0
Australia
Phone 100588 0
+61882048997
Fax 100588 0
Email 100588 0
bogda.koczwara@flinders.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?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7239 0
Study protocol
Citation [1] 7239 0
Link [1] 7239 0
Email [1] 7239 0
Other [1] 7239 0
Study protocol will be uploaded once final version is agreed upon by all project team members.
Attachment [1] 7239 0
Type [2] 7240 0
Informed consent form
Citation [2] 7240 0
Link [2] 7240 0
Email [2] 7240 0
Other [2] 7240 0
Informed consent forms for both stages of the study will be provided once approved via ethics.
Attachment [2] 7240 0
Type [3] 7242 0
Ethical approval
Citation [3] 7242 0
Link [3] 7242 0
Email [3] 7242 0
Other [3] 7242 0
Ethics and governance approval will be provided once received.
Attachment [3] 7242 0
Summary results
No Results