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Trial registered on ANZCTR


Registration number
ACTRN12616000615482
Ethics application status
Approved
Date submitted
4/05/2016
Date registered
12/05/2016
Date last updated
31/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient Reported Outcome Measures for Personalised Treatment and Care Phase 2 Project - an eHealth platform in cancer patient care
Scientific title
Patient Reported Outcome Measures for Personalised Treatment and Care Project Phase 2 - testing the functionality and acceptability of an oncology eHealth platform that is integrated into a hospital electronic record system.
Secondary ID [1] 289131 0
Nil
Universal Trial Number (UTN)
U1111-1182-6058
Trial acronym
PROMPT-CARE 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 298617 0
Condition category
Condition code
Cancer 298693 298693 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Completion of patient reported outcome (PRO) measures (PROMPT-Care survey) by patients as well as providing feedback via an evaluation survey and interviews on the acceptability of the eHealth system and usefulness of the self-management resources accessed. The interventions include;
a) The patients will complete the Distress Thermometer and Checklist, Edmonton Symptom Assessment Scale (ESAS) and Supportive Care Needs Survey – 9 items. Based on the patient’s results, they will be emailed links to self-management websites. These websites consist of publically available resources from reputable national (e.g. Cancer Council, Cancer Institute NSW) and international (e.g. McMillian) sources. Staff will receive a report summarising the results of the patient’s PROMPT-Care survey with recommendations for action, as developed by the study’s Clinical Advisory Group.
b) The PROMPT-Care survey measures items over 4 domains: Physical wellbeing (e.g. fatigue, pain, mouth sores), emotional wellbeing (e.g. anxiety, depression, loss of interest in activities), social and family wellbeing (e.g. support from family and friends, problems with partner) and practical support (e.g. transport, housing, being informed about test results).
c) The PROMPT-Care system is accessible by patients (to input PROMPT-Care survey results and to access self-management resources), staff at the cancer treatment centre (e.g. oncologists, nurse care coordinators, allied health staff), and selected members of the research team who have approval to access patients medical records using the MOSAIQ database. Results of patient surveys are integrated in to Mosaiq in which the clinician and other care providers can access report summaries to review patient reported outcomes as part of routine care.
d) Frequency of use – patients on active treatment or in follow up will complete the PROMPT-Care survey every 4 weeks (includes all previously mentioned assessments), depending on the schedule of their review appointments.
e) Duration of intervention = 6 months
f) Patients attending clinic will be asked to complete the PROMPT-Care survey in the waiting area, using an electronic tablet device. Patients in long-term follow-up will typically complete their PROMPT-Care survey from home, however should they be attending clinic for review they will be asked to complete that monthly survey while in the waiting area.
g) Strategies to monitor adherence: Patients who do not complete their PROMPT-Care surveys from home will receive reminder emails. We will also be conducting evaluation interviews with participants to get their views of the system and to discuss issues around their adherence to the project.
h) Participants will be asked to fill out an evaluation survey and to attend a single interview to assess their views on the eHealth platform, which will last approximately 20 minutes. Oncology hospital staff will be asked to attend a single interview to assess their views on the eHealth platform, which will last approximately 20 minutes.
i) Participants who are on-treatment at the commencement of the study and transition to follow-up care during the study will receive a Treatment Summary and Survivorship Care Plan. This care plan will be circulated to their nominated GP.
Intervention code [1] 294643 0
Other interventions
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298177 0
The composite primary outcome is to test the functionality and acceptability of the eHealth platform in a sample of cancer patients at three participating hospitals and focus on the assessment of:
-Participant uptake rates assessed through trial logs recording number of patients approached, entered study, number of follow-up calls made, research staff time for recruitment, and participant feedback on how they were made aware of the study;
-Extent of missing data from assessments undertaken by participants assessed through examination of PROMPT-Care reports to determine whether there is any systematically missing data;
-Accuracy and completeness of data transfer procedures (from the point of the patient completing an assessment to a report appearing via MOSAIQ) assessed by comparison of data received by MOSAIQ to data presented in reports;
-System response to PROMs over time (including escalation of self-management advice messages sent to patients, sending of clinical alerts, and patient consultation with GPs) assessed through implementation and evaluation of quality assurance checks to ensure the system is operating as expected;
-Acceptability of PROMPT-Care to participants assessed through evaluation survey and/or interviews with patients;
-Acceptability and perceived usefulness of the real-time reporting to clinicians assessed through evaluation interviews;
-Percent of eligible participants who complete more than one assessment assessed through study log records and participant tracking;
-Participants’ levels of self-reported distress, symptoms and unmet needs assessed through evaluation of patient data submitted and recorded through the PROMPT-Care survey;
-Utility of the self-management resources by patients though assessment of the patient use of the system; and
-Acceptability and utility of the Treatment Summary and Survivorship Care Plan from patient, oncology and primary care provider perspectives assessed through evaluation interviews
Timepoint [1] 298177 0
At end of recruitment period
Secondary outcome [1] 323394 0
Nil
Timepoint [1] 323394 0
Nil

Eligibility
Key inclusion criteria
- Are aged 18 years or over
- Are cognitively able to provide informed consent and understand the surveys
- Are either currently receiving cancer care (including follow-up care), or have recently been diagnosed with cancer and scheduled to commence cancer treatment at one of the participating sites
- Have sufficient English skills to complete the survey in English
- Have sufficient computer literacy
- Staff - current staff working in the oncology department at the recruitment hospitals.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Children and culturally and linguistically diverse (CALD) populations
- Staff not working in Oncology

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)
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/05/2016
Actual
20/05/2016
Date of last participant enrolment
Anticipated
30/11/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5723 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 5724 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 5725 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 13200 0
2170 - Liverpool
Recruitment postcode(s) [2] 13201 0
2500 - Wollongong
Recruitment postcode(s) [3] 13202 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 293501 0
Government body
Name [1] 293501 0
Cancer Institute NSW
Country [1] 293501 0
Australia
Primary sponsor type
Individual
Name
Afaf Girgis
Address
Ingham Institute
Psycho-Oncology
Locked Bag 7103
Liverpool BC
NSW 1871
Country
Australia
Secondary sponsor category [1] 292330 0
None
Name [1] 292330 0
Address [1] 292330 0
Country [1] 292330 0
Other collaborator category [1] 278984 0
Other
Name [1] 278984 0
CONCERT Translational Cancer Research Centre, Ingham Institute for Applied Medical Research
Address [1] 278984 0
1 Campbell Street
Liverpool NSW 2170
Country [1] 278984 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294945 0
South Western Sydney Local Health District
Ethics committee address [1] 294945 0
Locked Bag 7103
Liverpool BC
NSW 1871
Ethics committee country [1] 294945 0
Australia
Date submitted for ethics approval [1] 294945 0
12/06/2015
Approval date [1] 294945 0
01/09/2015
Ethics approval number [1] 294945 0
HREC/15/LPOOL/287

Summary
Brief summary
The primary purpose of this study is to implement an integrated eHealth platform to support and enable cancer survivors to achieve and maintain improved health and well-being and better cancer outcomes, and to assess the functionality and acceptability of the system.
Who is it for?
You may be eligible to join this study if you are aged 18 or over and are either currently receiving cancer care (including follow-up care), or have recently been diagnosed with cancer and scheduled to commence cancer treatment at one of the participating sites.
Study details
Participants will have access to the eHealth system which assesses symptoms, emotional well-being and unmet needs. Participants will have access to a range of self-management websites based on their survey responses. Staff will receive a patient report with clinical recommendations. Patients and oncology staff will have access to the system for 6 months. Patients will then be asked to complete a survey and an interview regarding their use and acceptability of the eHealth system. Staff will be asked to complete an interview only.
A sub-set of participants who are on-treatment at the commencement of the study and transition to follow-up care during the study will receive a Treatment Summary and Survivorship Care Plan that will also be provided to their GP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65590 0
Prof Afaf Girgis
Address 65590 0
Psycho-Oncology Research Group
Centre for Oncology Education and Research Translation (CONCERT)
Ingham Institute for Applied Medical Research
South Western Sydney Clinical School, UNSW Medicine
Liverpool Hospital
Locked Bag 7103
LIVERPOOL BC NSW 1871
Country 65590 0
Australia
Phone 65590 0
+61 2 8738 9246
Fax 65590 0
+61 2 9602 3221
Email 65590 0
afaf.girgis@unsw.edu.au
Contact person for public queries
Name 65591 0
Ivana Durcinoska
Address 65591 0
Psycho-Oncology Research Group
Centre for Oncology Education and Research Translation (CONCERT)
Ingham Institute for Applied Medical Research
South Western Sydney Clinical School, UNSW Medicine
Liverpool Hospital
Locked Bag 7103
LIVERPOOL BC NSW 1871
Country 65591 0
Australia
Phone 65591 0
+61 2 8738 9224
Fax 65591 0
+61 2 9602 3221
Email 65591 0
i.durcinoska@unsw.edu.au
Contact person for scientific queries
Name 65592 0
Ivana Durcinoska
Address 65592 0
Psycho-Oncology Research Group
Centre for Oncology Education and Research Translation (CONCERT)
Ingham Institute for Applied Medical Research
South Western Sydney Clinical School, UNSW Medicine
Liverpool Hospital
Locked Bag 7103
LIVERPOOL BC NSW 1871
Country 65592 0
Australia
Phone 65592 0
+61 2 8738 9224
Fax 65592 0
+61 2 9602 3221
Email 65592 0
i.durcinoska@unsw.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol for a controlled trial of an eHealth system utilising patient reported outcome measures for personalised treatment and care: PROMPT-Care 2.0.2018https://dx.doi.org/10.1186/s12885-018-4729-3
EmbaseWeb-Based Patient-Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care): Multicenter Pragmatic Nonrandomized Trial.2020https://dx.doi.org/10.2196/19685
N.B. These documents automatically identified may not have been verified by the study sponsor.