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Trial registered on ANZCTR


Registration number
ACTRN12618001878268
Ethics application status
Approved
Date submitted
7/10/2018
Date registered
19/11/2018
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Date results information initially provided
19/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patient Reported Outcome Measures in multiple myeloma: real-time rePorTing to improve care
Scientific title
Patient Reported Outcome Measures in multiple myeloma: real-time rePorTing to improve care
Secondary ID [1] 296203 0
Nil known
Universal Trial Number (UTN)
U1111-1221-3182
Trial acronym
My-PROMPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple myeloma 309840 0
Condition category
Condition code
Cancer 308629 308629 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a feasibility study. The patient completes the MyPOS quality of life questionnaire, which should take 7 to 8 minutes to complete, either by tablet whilst in the waiting room for their appointment, online (by emailed link) within a week of their visit, or by hard copy, before 4 clinical visits. The patient indicates whether they completed the questionnaire on their own or with help from a friend/relative or a staff member. A summary of results of concern is generated from the Myeloma and Related Diseases Registry electronic database by
clicking a button and printing the summary. It is provided to the treating clinician by the study coordinator or clinic staff before the first 3 visits. The clinician is made aware that results from the questionnaire summary are to be taken into account in the patient's care by the study coordinator or by an explanatory statement left with the questionnaire summary for the clinician. Visits are:
T1: close to diagnosis, T2: T1 + 1 month, T3: T1 + 6 months, T4: T1 + 10 months.
After each of the first 3 visits the clinician completes an evaluation questionnaire to assess the feasibility of the intervention and after T3 the patient completes an evaluation questionnaire to assess the feasibility of the intervention.
Intervention code [1] 312532 0
Other interventions
Comparator / control treatment
The patient completes the MyPOS quality of life questionnaire before T1 and T4. Results are not provided to the treating clinician and the clinician and patient don't complete evaluations.
Results from the Control arm questionnaires are used to compare change in heath-related quality of life from baseline to T4 between the 2 groups.
Control group
Active

Outcomes
Primary outcome [1] 307591 0
Patients' satisfaction with the survey: patients rate their satisfaction at the end of the patient evaluation questionnaire about the use of the MyPOS survey in the intervention arm.
Ratings are from 1 (Not at all satisfied) to 5 (Very satisfied). The primary outcome will be the median satisfaction rating out of 5 of all of the intervention arm patients.
A rating of 3 would be considered feasible, acceptable and non-inferior to routine care.
Timepoint [1] 307591 0
T3: T1 + 6 months
Primary outcome [2] 307963 0
Clinicians' satisfaction with the summary of the patient’s survey: clinicians rate their satisfaction at the end of the clinician evaluation questionnaire about the use of the MyPOS survey summary in the intervention arm.
Ratings are from 1 (Not at all satisfied) to 100 (Very satisfied). The primary outcome will be the median satisfaction rating out of 100 of all for the clinician evaluation questionnaires.
A rating of 50 would be considered feasible, acceptable and non-inferior to routine practice.
Timepoint [2] 307963 0
Clinician evaluation surveys are completed at T1, T2 (T1 + 1 month), T3 (T1+6 months).
Median satisfaction rating will be calculated for all clinician evaluation surveys together and then per timepoint.
Primary outcome [3] 307964 0
The proportion of responses indicating 'Strongly agree' or 'Agree', for the following question from the patient evaluation survey that assesses impact of the intervention on the consultation: 'My doctor discussed some of my responses to the survey in our consultation'.
Timepoint [3] 307964 0
T3: T1 + 6 months
Secondary outcome [1] 353499 0
The proportion of responses indicating 'Strongly agree' or 'Agree', for the following question from the patient evaluation survey that assesses impact of the intervention on the consultation: 'Completing the survey was a helpful way to communicate my concerns to my doctor.'
Timepoint [1] 353499 0
T3: T1 + 6 months
Secondary outcome [2] 353500 0
The proportion of responses indicating 'Strongly agree' or 'Agree', for the following question from the patient evaluation survey that assesses impact of the intervention on the consultation: 'My doctor referred to the survey in our consultation.'
Timepoint [2] 353500 0
T3: T1 + 6 months
Secondary outcome [3] 353501 0
The proportion of responses indicating 'No' for the following question from the clinician evaluation survey that assesses the accessibility of the MyPOS survey: 'Did you have any problems with accessing the results of the MyPOS survey report?'
Timepoint [3] 353501 0
T1, T2 and T3
Proportion of responses will include clinician surveys from all 3 timepoints.
Secondary outcome [4] 353565 0
The proportion of responses indicating 'No' for the following question from the clinician evaluation survey that assesses the accessibility of the MyPOS survey: 'Were the results available to you in a timely manner, i.e. before or at the time you were seeing the patient who completed the assessment?'
Timepoint [4] 353565 0
T1, T2 and T3
Proportion of responses will include clinician surveys from all 3 timepoints.
Secondary outcome [5] 353566 0
The proportion of responses indicating 'Yes' for the following question from the clinician evaluation survey that assesses impact of the intervention on the consultation: 'Did you use the survey results as a way of discussing the patient’s concerns?'
Timepoint [5] 353566 0
T1, T2 and T3.
Proportion of responses will include clinician surveys from all 3 timepoints.
Secondary outcome [6] 353567 0
The proportion of responses indicating 'Yes' for the following question from the clinician evaluation survey that assesses impact of the intervention on the consultation: 'Did you take any actions after seeing the results of the survey?'
Timepoint [6] 353567 0
T1, T2 and T3.
Proportion of responses will include clinician surveys from all 3 timepoints.
Secondary outcome [7] 353568 0
The proportion of responses indicating 'About right', for the following question from the patient evaluation survey that assesses patient experience of survey completion: 'How would you rate the amount of time it took to complete the survey?'
Timepoint [7] 353568 0
T3: T1 + 6 months
Secondary outcome [8] 353570 0
The proportion of responses indicating 'Strongly agree' or 'Agree', for the following question from the patient evaluation survey that assesses patient experience of survey completion: 'I felt comfortable answering the questions.'
Timepoint [8] 353570 0
T3: T1 + 6 months
Secondary outcome [9] 353571 0
The proportion of responses indicating 'Yes' for the following question from the clinician evaluation survey that assesses impact of the intervention on the consultation: 'Do you think the tool is practical for routine use?'
Timepoint [9] 353571 0
T1, T2 and T3.
Proportion of responses will include clinician surveys from all 3 timepoints.
Secondary outcome [10] 353574 0
The change in health-related quality of life from T1 to T4 compared between groups. This will be assessed by comparing change in the MyPOS total score as well as the change in scores for the 3 MyPOS components: Symptoms and Function, Emotional Response and Healthcare Support between groups.
Timepoint [10] 353574 0
T4: T1 + 10 months
This outcome can be assessed after T4.

Eligibility
Key inclusion criteria
Patients with newly diagnosed multiple myeloma who have not received any prior treatment or they are within 7 days of day 1 of treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are not registered on the Myeloma and Related Diseases Registry

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was from a central administering institution and not a member of staff at the recruiting site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random order for the allocation of subjects into different groups was generated using permuted block randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary aim: quantitative analysis of the patient and clinician evaluation survey data will be undertaken to determine whether the intervention could feasibly be continued and extended to other sites.
Secondary aim: we will compare change in total MyPOS score from baseline (T1) to 10 months post baseline (T4), between groups, to detect any trend towards a difference in health-related quality of life (HRQOL) between groups. The change in scores for the 3 MyPOS components (Symptoms and Function, Emotional Response and Healthcare Support) will also be assessed and compared in the same way between groups.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
8/05/2017
Date of last participant enrolment
Anticipated
Actual
12/10/2018
Date of last data collection
Anticipated
31/08/2019
Actual
Sample size
Target
30
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 12030 0
The Alfred - Prahran
Recruitment hospital [2] 12031 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 12032 0
Epworth Freemasons - Melbourne
Recruitment hospital [4] 12034 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 24187 0
3004 - Prahran
Recruitment postcode(s) [2] 24188 0
2050 - Camperdown
Recruitment postcode(s) [3] 24189 0
3002 - Melbourne
Recruitment postcode(s) [4] 24190 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 300791 0
Commercial sector/Industry
Name [1] 300791 0
Gilead
Country [1] 300791 0
Australia
Funding source category [2] 300795 0
Commercial sector/Industry
Name [2] 300795 0
Takeda
Country [2] 300795 0
Australia
Primary sponsor type
University
Name
Monash University
Address
553 St Kilda Rd
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 300339 0
None
Name [1] 300339 0
Address [1] 300339 0
Country [1] 300339 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301575 0
Alfred Health Ethics Committee
Ethics committee address [1] 301575 0
Commercial Rd
Melbourne
VIC 3004
Ethics committee country [1] 301575 0
Australia
Date submitted for ethics approval [1] 301575 0
09/02/2017
Approval date [1] 301575 0
11/04/2017
Ethics approval number [1] 301575 0
52/17

Summary
Brief summary
This study will test whether it is feasible to collect information on quality of life in patients living with myeloma and provide this to treating clinicians in real-time at clinical visits.

Who is it for?
You may be eligible to join this study if you are aged 18 years or more and have newly diagnosed multiple myeloma for which you have not received any prior treatment or are within 7 days of day 1 of treatment.

Study details
Participants will be randomly allocated (by chance) to one of two groups. Participants in one group will complete a quality of life questionnaire before 4 clinical visits and a summary of results of concern are provided to the treating clinician before the first 3 visits. The clinician is made aware that results from the questionnaire summary are to be taken into account in the patient's care. Participants in the other group will complete the same questionnaire before visits 1 and 4 only, and results are not provided to the treating clinician.

Feasibility of the intervention will be assessed by patient and clinician evaluation surveys, clinician interviews and site study coordinator observations. Quality of life scores will also be compared between groups. The theory is that increasing clinicians' awareness of issues affecting patients quality of life could help to improve patient care.
Trial website
mrdr.net.au
My-PROMPT is a substudy of the Myeloma and Related Diseases Registry.
Trial related presentations / publications
HAA 2017 poster: Patient-reported outcomes in multiple myeloma: real-time reporting to improve care (Methodology of the My-PROMPT study).
HAA (now called Blood) is the key annual haematology meeting in ANZ.

Blood 2018 - Myeloma and Related Diseases Registry Interest Group breakfast meeting, Monday Oct 22 - My-PROMPT presented as a substudy of the MRDR.
Public notes

Contacts
Principal investigator
Name 87438 0
Dr Elizabeth Moore
Address 87438 0
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Rd
Melbourne
VIC 3004
Country 87438 0
Australia
Phone 87438 0
+61 3 99030355
Fax 87438 0
Email 87438 0
[email protected]
Contact person for public queries
Name 87439 0
Elizabeth Moore
Address 87439 0
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Rd
Melbourne
VIC 3004
Country 87439 0
Australia
Phone 87439 0
+61 3 99030355
Fax 87439 0
Email 87439 0
[email protected]
Contact person for scientific queries
Name 87440 0
Elizabeth Moore
Address 87440 0
School of Public Health and Preventive Medicine
Monash University
553 St Kilda Rd
Melbourne
VIC 3004
Country 87440 0
Australia
Phone 87440 0
+61 3 99030355
Fax 87440 0
Email 87440 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Some data pertains to the Australia and New Zealand Myeloma and Related Diseases Registry, Monash University. Consultation / approval is required.


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
80Study protocol  [email protected]
23695Informed consent form  [email protected]
23696Ethical approval  [email protected]

Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Moore EM, King TA, Wood EM, Ruseckaite R, Klarica ... [More Details]
Other filesNo Patient Reported Outcome Measures in multiple myel... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AISecond generation BTK inhibitors impair the anti-fungal response of macrophages and neutrophils2020https://doi.org/10.1002/ajh.25816
N.B. These documents automatically identified may not have been verified by the study sponsor.