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Trial registered on ANZCTR


Registration number
ACTRN12620000303943
Ethics application status
Approved
Date submitted
24/02/2020
Date registered
5/03/2020
Date last updated
22/10/2021
Date data sharing statement initially provided
5/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Electronic Patient Reported Outcome Measures (PROMs) in Blood Cancer Patients: A Pilot Study
Scientific title
Use of a Supportive Care Screening tool in blood cancer patients undergoing treatment; feasibility and success of an electronic Patient Reported Outcome Measures (PROMs) and nurse led assessment to meet patients' wellness needs: a pilot study
Secondary ID [1] 300599 0
Nil known
Universal Trial Number (UTN)
U1111-1248-5402
Trial acronym
ePROMs in Blood Cancer
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Haematological malignancy 316349 0
Condition category
Condition code
Cancer 314605 314605 0 0
Hodgkin's
Cancer 314606 314606 0 0
Leukaemia - Acute leukaemia
Cancer 314607 314607 0 0
Leukaemia - Chronic leukaemia
Cancer 314608 314608 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 314609 314609 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 314610 314610 0 0
Myeloma
Cancer 314611 314611 0 0
Other cancer types
Blood 314613 314613 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PROMs trial will assess the adequacy, feasibility and acceptability of an electronic screening tool (electronic PROMs) in addressing the supportive care needs of blood cancer patients). We aim to facilitate a timely response to supportive care needs and increase appropriate allied health referrals, by identifying and acting on clinically significant responses to screening tools. The PROMs trial has both prospective and retrospective (historical) arms.

Prospective arm:
The electronic PROMs comprises two existing supportive care screening tools: the Malnutrition Screening Tool and the National Comprehensive Cancer Network's Distress Thermometer and Problem List, with additional questions regarding exercise. Overall, participant distress, supportive care needs, nutritional status and physical activity will be assessed. These screening tools have been synthesised into the electronic PROMs through the secure survey database Google Forms.
Participants will be provided with pre-programmed touchscreens to complete the electronic PROMs during each visit to the outpatient haematology centre, with the view that it is completed at every scheduled appointment over a 6-month period. This will vary depending on the frequency of participants treatments and may be from weekly to 4 weekly. The electronic PROMs will take approximately 2-5 minutes to complete. In addition, participants will be provided with a URL to access and complete the electronic PROMs at home if needed. This will not be scheduled or expected, but can be used by participants if they experience a change in symptoms or needs and will be on an ad hoc basis only. Surveys completed from home will be identified by a direct question on the PROMs.
Responses to the electronic PROMs will be viewed and actioned within 3 days. Participants who provide pre-determined 'clinically significant' responses will be automatically flagged on the survey database. An appointment will be subsequently scheduled for these participants with the nurse project coordinator, a specialised haematology nurse with many years' experience. The purpose of this appointment is to discuss supportive care needs and refer participants to appropriate allied health services. The number and pattern of referrals to allied health services (specifically psychology, dietetics, social work and exercise physiology) will be recorded by the nurse project coordinator. Participants adherence to the intervention will be monitored in real time - trial participants will be flagged in advance of their attendance for treatment to ensure completion of survey. Study personnel are notified immediately of completion of surveys and so with the support for administrative staff can ensure same day completion. Reasons for failure to complete survey will be captured to inform feasibility of PROMs.
Participants will also complete a once-off electronic 'prospective participant satisfaction survey' (PPSS), designed to assess the acceptability of the electronic PROMs. This is to be completed at the end of the 12-month study period, via touchscreens provided at the outpatient centre.
Each participant in this arm will receive the same interventions (electronic PROMs and PPSS). Participants may receive different allied health referrals, depending on their responses to the electronic PROMs.
Intervention code [1] 316908 0
Early detection / Screening
Comparator / control treatment
Participants recruited to the retrospective arm of the project will complete a mailed, paper-based satisfaction survey. This survey will assess the attitudes of retrospective participants towards supportive care screening, prior to the implementation of the electronic PROMs, including whether or not their supportive care needs were identified, understood and appropriately addressed with referrals to allied health. Responses to this survey will be contrasted against the satisfaction of participants receiving the electronic PROMs in the prospective arm of the study.
The survey will be posted via reply paid mail to eligible retrospective participants at the commencement of the six month study period. Participants are instructed to complete the survey and return via post to the study centre, prior to the conclusion of the six-month period.
Control group
Historical

Outcomes
Primary outcome [1] 322986 0
Percentage change in referrals to allied health services (specifically psychology, social work, dietetics and exercise physiology), by comparing prospective study data against existing data on referrals from the same twelve-month period of the previous year
Timepoint [1] 322986 0
12 months after commencement of the study period
Primary outcome [2] 322987 0
Acceptability of the electronic PROMs to participants, as determined by qualitative data from a 'satisfaction' survey.

The electronic PROMs is a questionnaire designed specifically for the project. It includes the National Comprehensive Cancer Network's 'Distress Thermometer and Problem List', a validated screening tool, with additional, non-validated questions to screen for nutritional status and physical activity.

The satisfaction survey is designed specifically for the project.
Timepoint [2] 322987 0
12 months after commencement of the study period
Secondary outcome [1] 380454 0
Optimal time points for completion electronic PROMS based on completion rates and qualitative data from PROMS and satisfaction surveys
Timepoint [1] 380454 0
Assessed 12 months post commencement of study period

Eligibility
Key inclusion criteria
Prospective arm:
1. Participants with a diagnosis of haematological malignancy (including, but not limited to, myeloma, lymphoma, leukaemia, myelodysplastic and myeloproliferative syndromes), attending the study centre
2. In receipt of treatment for their haematological malignancy during the twelve-month study period (including, but not limited to, parenteral chemotherapy and immunotherapy, oral chemotherapy/disease directed therapy or regular blood product transfusions)

Retrospective arm:
1. Participants with a diagnosis of haematological malignancy (including, but not limited to, myeloma, lymphoma, leukaemia, myelodysplastic and myeloproliferative syndromes)
2. Attended the study centre between 28/05/19 - 27/05/2020 for treatment of their haematological malignancy
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For both prospective and retrospective arms, patients who are unable to speak or write the English language are not eligible for participation in this study.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This project involves a prospective and a retrospective (historical) arm. Prospective participants are those who receive treatment for haematological malignancy during the study period, whereas retrospective participants received treatment over the same twelve-month period of the previous year.
Prospective participants will be a single group who receive the same intervention. This group will complete the electronic PROMs questionnaire which aims to identify and address unmet supportive care needs, frequently throughout their treatment, Their supportive care needs and allied health referrals may differ based on differing needs. The satisfaction of prospective and retrospective participants with supportive care screening, as well as data on referrals provided, will be analysed.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A defined period of time is allocated to recruit participants on the prospective arm, rather than a target recruitment number to achieve outcomes.

All eligible participants during the study period will be included and a descriptive analysis will be conducted including comparative rates of referrals to allied health, and qualitative assessment of satisfaction of the electronic PROMs. Analysis will focus on clinical relevance rather than statistical significance including changes in referral patterns.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/03/2020
Actual
28/05/2020
Date of last participant enrolment
Anticipated
1/12/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
120
Accrual to date
61
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15958 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 29451 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 305022 0
Hospital
Name [1] 305022 0
Cabrini Health
Country [1] 305022 0
Australia
Primary sponsor type
Hospital
Name
Cabrini Hospital
Address
183 Wattletree Rd Malvern VIC 3144
Country
Australia
Secondary sponsor category [1] 305379 0
None
Name [1] 305379 0
N/A
Address [1] 305379 0
N/A
Country [1] 305379 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305417 0
Cabrini Human Research and Ethics Committee
Ethics committee address [1] 305417 0
Ethics committee country [1] 305417 0
Australia
Date submitted for ethics approval [1] 305417 0
24/02/2020
Approval date [1] 305417 0
01/04/2020
Ethics approval number [1] 305417 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100310 0
A/Prof Melita Kenealy
Address 100310 0
Cabrini Hospital
CHOC Level 2, 183 Wattletree Rd Malvern VIC 3144
Country 100310 0
Australia
Phone 100310 0
+61 3 9500 9345
Fax 100310 0
Email 100310 0
melita.kenealy@thebloodunit.com.au
Contact person for public queries
Name 100311 0
Melita Kenealy
Address 100311 0
Cabrini Hospital
CHOC Level 2, 183 Wattletree Rd Malvern VIC 3144
Country 100311 0
Australia
Phone 100311 0
+61 3 9500 9345
Fax 100311 0
Email 100311 0
melita.kenealy@thebloodunit.com.au
Contact person for scientific queries
Name 100312 0
Melita Kenealy
Address 100312 0
Cabrini Hospital
CHOC Level 2, 183 Wattletree Rd Malvern VIC 3144
Country 100312 0
Australia
Phone 100312 0
+61 3 9500 9345
Fax 100312 0
Email 100312 0
melita.kenealy@thebloodunit.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
not applicable for study design


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
No additional documents have been identified.