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Trial registered on ANZCTR


Registration number
ACTRN12620001149954
Ethics application status
Approved
Date submitted
25/08/2020
Date registered
3/11/2020
Date last updated
3/11/2020
Date data sharing statement initially provided
3/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study to embed electronic Patient Reported Outcome Measures and patient reported experience measures into routine care for patients with Stage III MELanoma (ePROMs-MEL)
Scientific title
Pilot study to embed electronic Patient Reported Outcome Measures and patient reported experience measures into routine care for patients with Stage III MELanoma (ePROMs-MEL)
Secondary ID [1] 302099 0
None
Universal Trial Number (UTN)
U1111-1257-2777
Trial acronym
ePROMs-MEL
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Melanoma - Stage III 318716 0
Psychosocial stress 318717 0
Quality of life 318718 0
Mental Health
 319154 0
Condition category
Condition code
Cancer 316732 316732 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete PROM questionnaires at their initial recruitment visit (baseline) and at 3-4 monthly intervals over a 12 month period (between 4-5 times). This schedule is designed to coincide with their routine clinical follow-up appointments.
At each visit, all patients will be required to complete two short questionnaires that are used to assess their psychosocial distress and quality of life: 1. the National Comprehensive Cancer Centre (NCCN)’s Distress Thermometer (DT) and Problem List for Patients; and 2. EuroQoL’s EQ-5D-5L and visual analogue scale. Patients who score above the clinical cut off score on these measures (4 or above on DT and 3 or above on any of the five EQ-5D-5L questions), indicating a moderate or higher level of psychosocial distress or moderate quality of life impairment, will then be required to complete an additional three questionnaires: the Melanoma Concerns Questionnaire (MCQ-28), the Depression, Anxiety and Stress Scale (DASS-21) and the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30). These additional questionnaires will provide more detailed information about potential areas of support needs. Completion time for all five questionnaires is expected to be less than 30 minutes.
All questionnaires used in this study have been validated in previous studies. The MCQ-28 is a recently-developed questionnaire which includes some patient-reported experience measures (PREMs) in addition to PROMs. The remaining four questionnaires cover PROMs only.
Data will be collected on time taken to complete questionnaires and on the number of times the questionnaires were completed (out of a maximum of five times). In addition, the
number of questions answered in the second set of three questionnaires (all questions in the first set of two questionnaires are mandatory) will be recorded.
Intervention code [1] 318398 0
Other interventions
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324867 0
To evaluate the feasibility of embedding electronic PROMs into routine care from the perspective of Stage III melanoma patients. This will be assessed by the proportion of patients who complete at least baseline and one other set of PROMs questionnaires, out of a maximum possible five time points. For the intervention to be considered feasible, 60% of participants must complete questionnaires at baseline and at least one other time point.
Timepoint [1] 324867 0
This outcome will be measured at baseline, 3, 6, 9 and 12 months.
Primary outcome [2] 325202 0
To evaluate the feasibility of embedding electronic PROMs into routine care from the perspective of the patient's treating clinical team (i.e. surgeons, dermatologists, medical oncologists, psychologists and nurses). This will be assessed by clinician responses to surveys and semi-structured interviews conducted at the end of the study.
Timepoint [2] 325202 0
This outcome will be measured at 12 months.
Primary outcome [3] 325203 0
To evaluate the acceptability of embedding electronic PROMs into routine care from the perspective of Stage III melanoma patients. This will be assessed by patient responses to surveys and semi-structured interviews conducted at the end of the study.
Timepoint [3] 325203 0
This outcome will be measured at 12 months.
Secondary outcome [1] 386027 0
This is the final primary outcome. To evaluate the acceptability of embedding electronic PROMs into routine care from the perspective of the patient's treating clinical team (i.e. surgeons, dermatologists, medical oncologists, psychologists and nurses). This will be assessed by clinician responses to surveys and semi-structured interviews conducted at the end of the study.
Timepoint [1] 386027 0
This outcome will be measured at 12 months.
Secondary outcome [2] 387168 0
To evaluate whether embedding electronic PROMs leads to increase patient referrals. This will be measured by comparison of the number of referrals of patients to support services before and after the intervention. The number of referrals will be assessed via clinic records.
Timepoint [2] 387168 0
18 months
Secondary outcome [3] 387170 0
The production of a framework for the data systems required to enable electronic data capture and feedback to clinicians in real-time. This will be assessed by responses from patients and clinicians about the ease of use and relevance of the questionnaire data (through survey and semi-structured interviews).
Timepoint [3] 387170 0
12 months.
Secondary outcome [4] 388073 0
NCCN Distress Thermometer and Problem List for Patients outcomes are
Psychosocial distress and five categories of problems: practical, family, emotional, spiritual/religious and physical.
Timepoint [4] 388073 0
Baseline, 3, 6, 9 and 12 months.
Secondary outcome [5] 388075 0
The Euro-QoL EQ-5D-5L outcomes cover the following domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression and an overall health score.
Timepoint [5] 388075 0
Baseline, 3, 6, 9 and 12 months.
Secondary outcome [6] 388076 0
The Melanoma Concerns Questionnaire measures the following outcomes: Disease prognosis and acceptance; Treatment concerns / Future disease risk; Care delivery /Communication; Supportive Care; Melanoma surgery site; and Social circumstances.
Timepoint [6] 388076 0
Baseline, 3, 6, 9 and 12 months.
Secondary outcome [7] 388077 0
The DASS 21 questionnaire measures depression, anxiety and stress.
Timepoint [7] 388077 0
Baseline, 3, 6, 9 and 12 months.
Secondary outcome [8] 388078 0
The EORTC QLQ-C30 measures the following outcomes: Global health status and quality of life; physical functioning;
role functioning; emotional functioning; cognitive functioning; social functioning; fatigue; nausea and vomiting; pain; dyspnoea; insomnia; appetite loss; constipation; diarrhoea; and financial difficulties.
Timepoint [8] 388078 0
Baseline, 3, 6, 9 and 12 months.

Eligibility
Key inclusion criteria
Patient key inclusion criteria:
• Adults (over 18)
• Diagnosis of Stage III melanoma at least 3 months earlier
• Under the care of melanoma clinicians at MIA or RPAH
• Sufficient English and cognitive ability to comprehend study materials, provide informed consent and participate in this study
Clinician inclusion criteria:
• Clinicians currently treating and managing patients with stage III melanoma at Sydney Melanoma Surgical Oncology clinics at MIA or RPAH.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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
This is a Pilot study, so sample size has not been calculated. The aim is to recruit a minimum of 100 patients. We are using a mixed methods approach.

Quantitative analysis
Participant demographics and characteristics will be summarised for all participants using means and standard deviations. In addition, the consent, participation, and completion rates will be analysed. Consent will be defined as agreeing to participate in the study and returning a signed consent form; participation, as completing some of the components of the study; and completion, as completing all components of the study. Specifically, the proportion of eligible participants who completed the project tasks will be assessed to determine whether the inclusion of ePROMs/ePREMs are acceptable for patients undergoing follow-up treatment for stage III melanoma. Descriptive statistics will be reported for HR-QoL and other questionnaire domain scores at baseline and follow-up time points. Referral and referral uptake rates will also be calculated. The small sample size of 100 for this pilot study precludes any sub-group analysis. The proportion of missing data is a project outcome that will not require adjustment.

Qualitative analysis
Results from semi-structured patient interviews conducted at the conclusion of the project will be reported to assess patient views on the usability, benefits and limitations of the study questionnaires they completed, whether questionnaire results were discussed within the subsequent clinical consultation, and if so whether this led to any change in management. Similarly, results from end of study clinician interviews will report their views on the feasibility, acceptability, benefits, limitations and usefulness of including ePROMs/ePREMs into the routine care for patients within their practice.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2020
Actual
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17304 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 17305 0
The Poche Centre, Melanoma Institute Australia - North Sydney
Recruitment postcode(s) [1] 31030 0
2050 - Camperdown
Recruitment postcode(s) [2] 31031 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 306517 0
Government body
Name [1] 306517 0
NHMRC Centre of Research Excellence in Melanoma grant
Country [1] 306517 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 307050 0
None
Name [1] 307050 0
Address [1] 307050 0
Country [1] 307050 0
Other collaborator category [1] 281437 0
Charities/Societies/Foundations
Name [1] 281437 0
Melanoma Institute Australia
Address [1] 281437 0
40 Rocklands Rd
Wollstonecraft NSW 2065
Country [1] 281437 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306721 0
St Vincent's Hospital, Sydney
Ethics committee address [1] 306721 0
Ethics committee country [1] 306721 0
Australia
Date submitted for ethics approval [1] 306721 0
Approval date [1] 306721 0
19/09/2019
Ethics approval number [1] 306721 0
2019/ETH10558

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

Contacts
Principal investigator
Name 104790 0
Prof Rachael Morton
Address 104790 0
NHMRC Clinical Trials Centre
Medical Foundation Building
92-94 Parramatta Road, Camperdown NSW 2050
Country 104790 0
Australia
Phone 104790 0
+61 2 9562 5013
Fax 104790 0
+61 2 9565 1863
Email 104790 0
rachael.morton@ctc.usyd.edu.au
Contact person for public queries
Name 104791 0
Kathy Dempsey
Address 104791 0
NHMRC Clinical Trials Centre
Medical Foundation Building
92-94 Parramatta Road, Camperdown NSW 2050
Country 104791 0
Australia
Phone 104791 0
+61 2 9562 5014
Fax 104791 0
+61 2 9565 1863
Email 104791 0
kathy.dempsey@ctc.usyd.edu.au
Contact person for scientific queries
Name 104792 0
Kathy Dempsey
Address 104792 0
NHMRC Clinical Trials Centre
Medical Foundation Building
92-94 Parramatta Road, Camperdown NSW 2050
Country 104792 0
Australia
Phone 104792 0
+61 2 9562 5014
Fax 104792 0
Email 104792 0
kathy.dempsey@ctc.usyd.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
Data from this project will include individual patient's raw scores from Patient-Reported Outcomes Measures and confidential qualitative interview data. To protect patient privacy, only de-identified summary data will be available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8892Ethical approval    380433-(Uploaded-25-08-2020-16-17-49)-Study-related document.docx
9257Study protocolWe intend to publish the study protocol and will submit for publication once we have the latest amendments accepted by HREC.  
9258Informed consent formThis has undergone some minor amendments and will be available once the amendments are approved by HREC.   It will be available as an online appendix of the ... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEmbedding electronic patient-reported outcome measures into routine care for patients with stage III MELanoma (ePROMs-MEL): Protocol for a prospective, longitudinal, mixed-methods pilot study.2022https://dx.doi.org/10.1136/bmjopen-2022-066852
N.B. These documents automatically identified may not have been verified by the study sponsor.