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Trial registered on ANZCTR


Registration number
ACTRN12615001352594
Ethics application status
Approved
Date submitted
15/09/2015
Date registered
14/12/2015
Date last updated
30/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patient Reported Outcome Measures for Personalised Treatment and Care Pilot Project - feasibility of an eHealth platform in cancer patient care.
Scientific title
Patient Reported Outcome Measures for Personalised Treatment and Care Pilot Project in cancer patients testing the implementation of an oncology eHealth platform that is integrated into one type of hospital electronic record system.
Secondary ID [1] 287457 0
Nil
Universal Trial Number (UTN)
U1111-1174-2787
Trial acronym
PROMPT-Care Pilot Project.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 296180 0
Condition category
Condition code
Cancer 296457 296457 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 5 domains: Physical wellbeing (e.g. fatigue, pain, mouth sores), emotional wellbeing (e.g. anxiety, depression, loss of interest in activities), functional wellbeing (e.g. getting around, memory and cognition), 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.
d) Frequency of use – patients on active treatment will complete the PROMPT-Care survey every 2-4 weeks, depending on the schedule of their review appointments. Patients in long-term follow-up care will be asked to complete the survey on a monthly basis. Patients completing the PROMPT-Care survey every 2-3 weeks will complete the Distress Thermometer and Checklist, and ESAS only. The Supportive Care Needs Survey is only administered on every second assessment for participants completing the PROMPT-Care Survey every 2-3 weeks as that measure has been validated using a 4 week time frame. Participants completing the PROMPT-Care survey on a monthly basis will always complete the full assessment (i.e. DT and checklist, ESAS and Supportive Care Needs Survey-9 items) An assessment schedule is established when the participant enters the study that indicates the frequency and pattern of assessments that the participant will receive.
e) Duration of intervention = 3-4 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: As this is a pilot project to determine the feasibility and acceptability of the PROMPT-Care system we will send patients who do not complete their PROMPT-Care surveys from home one reminder email. 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.
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.
Intervention code [1] 292829 0
Other interventions
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296079 0
the composite primary outcome is to test the functionality and acceptability of the pilot eHealth platform in a sample of cancer patients at two participating hospitals and focus on the assessment of:
- Feasibility of participant recruitment and consenting procedures 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;
- Participant eligibility, consent and response rates assessed by examination of reasons for exclusion (e.g. lack of IT knowledge, English language proficiency), refusal (e.g. not interested, too sick);
- 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;
- Acceptability of the eHealth platform 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;
- Collection of preliminary data on participants’ distress, symptoms and unmet needs recorded through the PROMPT-Care survey.
Timepoint [1] 296079 0
At end of recruitment period
Secondary outcome [1] 317447 0
Nil
Timepoint [1] 317447 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
- Staff - current staff working in the oncology department at the recruitment hospitals.
Minimum age
18 Years
Maximum age
No limit
Gender
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Patient surveys will provide quantitative data, which will be summarised and presented as means and standard deviations. The range, mean and standard deviation of data on patient usage time and number of missed assessments will be calculated and summarised by sub-groups e.g. by age, gender, cancer type etc.
Interviews with patients and hospital staff will be audio-recorded and transcribed verbatim. Initially, each interview transcript will be read at least once in its entirety to gain a sense of the content. All transcripts will be reviewed line-by-line (microanalysis) and words, statements, or paragraphs pertaining to the study objectives will be coded. Interpretation and clustering of the codes will result in noting themes, patterns, and categories and the relationships among these. A proportion of the transcripts will be coded by two independent members of the research team and emerging findings will be discussed at regular project meetings to enhance credibility.
The information gathered from the cognitive interviews will allow us to identify any problem areas in terms of interpreting and understanding the survey instructions, questions and answer options; how they were using the interface; and any problem areas in terms of accessing the self-management resources, which ones they used, and which ones were most helpful. The video recordings will be matched with the audio recordings to see what the participant was looking at at the time they made various comments.
We will perform a qualitative analysis of transcribed audio-recordings of the consultations. A ‘thematic survey’ method will be applied, focussing on the use of the report, the way it is consulted and discussed, the types of concerns raised by patients, caregivers and oncologists, and referrals made to other services and health professionals.
Analyses will be completed by the Project Officer and an Ingham Institute statistician under guidance and supervision of PI Girgis.

Recruitment
Recruitment status
Completed
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] 4334 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 4335 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 10478 0
2500 - Wollongong
Recruitment postcode(s) [2] 10479 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 292027 0
Government body
Name [1] 292027 0
Cancer Institute NSW
Address [1] 292027 0
PO Box 41
Alexandria NSW 1435
Country [1] 292027 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] 290697 0
None
Name [1] 290697 0
Address [1] 290697 0
Country [1] 290697 0
Other collaborator category [1] 278619 0
Other Collaborative groups
Name [1] 278619 0
CONCERT Translational Cancer Research Centre, Ingham Institute for Applied Medical Research
Address [1] 278619 0
1 Campbell Street
Liverpool NSW 2170
Country [1] 278619 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293513 0
South Western Sydney Local Health District
Ethics committee address [1] 293513 0
Locked Bag 7103
Liverpool BC
NSW 1871
Ethics committee country [1] 293513 0
Australia
Date submitted for ethics approval [1] 293513 0
25/09/2014
Approval date [1] 293513 0
24/10/2014
Ethics approval number [1] 293513 0
HREC/14/LPOOL/405

Summary
Brief summary
The primary purpose of this study is to develop and 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 feasibility 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 3 to 4 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. It is hoped that the findings of this pilot trial will provide information on the feasibility and usefulness of such a tool in improving the health and well-being in cancer patients.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 60254 0
Prof Afaf Girgis
Address 60254 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 60254 0
Australia
Phone 60254 0
+61 2 8738 9246
Fax 60254 0
+61 2 9602 3221
Email 60254 0
afaf.girgis@unsw.edu.au
Contact person for public queries
Name 60255 0
Dr Janelle Levesque
Address 60255 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 60255 0
Australia
Phone 60255 0
+61 2 8738 9244
Fax 60255 0
Email 60255 0
j.levesque@unsw.edu.au
Contact person for scientific queries
Name 60256 0
Dr Janelle Levesque
Address 60256 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 60256 0
Australia
Phone 60256 0
+61 2 8738 9244
Fax 60256 0
Email 60256 0
j.levesque@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary