Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001290987
Ethics application status
Approved
Date submitted
22/09/2020
Date registered
30/11/2020
Date last updated
30/05/2024
Date data sharing statement initially provided
30/11/2020
Date results information initially provided
30/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
PROMISE: Patient Reported Outcome Measures in cancer care: a hybrid effectiveness-Implementation trial to optimise Symptom control and health service Experience
Scientific title
PROMISE: Patient Reported Outcome Measures in cancer care: a hybrid effectivenessness-Implentation trial to optimise Symptom control and health service Experience. A randomised controlled trial of electronic self-reporting of symptoms versus usual care during and following treatment in cancer patients, focusing on patient outcomes.
Secondary ID [1] 302051 0
QIMR Berghofer Medical Research Institute: Project number P3622
Universal Trial Number (UTN)
U1111-1257-4820
Trial acronym
PROMISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 318647 0
Condition category
Condition code
Cancer 316663 316663 0 0
Bowel - Anal
Cancer 317114 317114 0 0
Breast
Cancer 317115 317115 0 0
Head and neck
Cancer 317116 317116 0 0
Lung - Small cell
Cancer 317117 317117 0 0
Pancreatic
Cancer 317118 317118 0 0
Prostate
Cancer 317119 317119 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
e-Prom (electronic patient reported outcome measures) comprising of a short questionnaire administered via an electronic platform prior to clinic appointments (during treatment and follow-up) and monthly or as desired by the patient between follow-up appointments. The tools provide information only and thus are not classed as medical devices.
It is anticipated that the e-PROM will take 10 minutes to complete, The questionnaires are sent by link via email/SMS and will be self-administered, the links are monitored by research nurse. The overall duration of e-PROM use will be up to 2 years from date of consent. Adherence to intervention is monitored at time of clinical visit, if patient has not completed pre-visit e-Prom the research nurse will assist them to log onto study iPad and complete questionnaire prior to seeing clinician.
Intervention code [1] 318355 0
Treatment: Other
Comparator / control treatment
The control group will receive standard care, in that they will not complete the electronic tool throughout the study
Control group
Active

Outcomes
Primary outcome [1] 324788 0
The rate of unplanned hospital presentations/admissions will be treated as a composite outcome. This information will be obtained from hospital records and linkage to Queensland Health Admitted Patients Data Collection (QHAPDC), Emergency Data and Medical Benefits Scheme (MBS) data.
Timepoint [1] 324788 0
At completion of all patient recruitment and all clinical follow-up and access to data linkage
Clinical follow up will occur at baseline (post recruitment) at 12 months and 24 months from date of consent (primary endpoint).
Primary outcome [2] 324789 0
Physical and functional well-being is a composite primary outcome and is measured by the Physical Wellbeing and Functional subscales of the Functional Assessment of Cancer Treatment - General (FACT-G) scale
Timepoint [2] 324789 0
At completion of patient treatment and the completion of the patient's FACT-G questionnaire at 6 months post consent date.
Secondary outcome [1] 385747 0
Rates of treatment completion: proportion of planned treatment received, information about planned treatment dose reductions and delays will be obtained from medical records
Timepoint [1] 385747 0
At completion of patient cancer treatment
Secondary outcome [2] 385748 0
levels of patient distress measured by the Hospital Anxiety and Depression Scale (HADS) using cut-points of >= 10 to indicate clinical anxiety or depression and 8-10 to indicate sub-clinical anxiety or depression
Timepoint [2] 385748 0
Baseline, 3, 6, 12, 18, 24 months from date of consent
Secondary outcome [3] 385749 0
Overall well-being measured by the Functional Assessment of Cancer Treatment – General (FACT-G) scale
Timepoint [3] 385749 0
Baseline, 3, 6, 12, 18, 24 months from date of consent
Secondary outcome [4] 385750 0
Symptom burden measured by the Memorial Symptom Assessment Scale (MSAS) which assesses the presence, severity and distress caused by 32 individual symptoms.
Timepoint [4] 385750 0
Baseline, 3, 6,12,18, 24 months from date of consent
Secondary outcome [5] 385751 0
Numbers of out-patient visits; information will be obtained from hospital records and linkage to Emergency Data and Medical Benefits Scheme (MBS) data.
Timepoint [5] 385751 0
At end of active follow-up period ( 2years) we will follow participants passively once every 12 months for up to an additional 5 years
Secondary outcome [6] 388041 0
Patient care experience
Timepoint [6] 388041 0
At completion of study at 2 year time point measured by Australian Hospital Patient Experience Question Set (AHPEQS)
Secondary outcome [7] 388042 0
cost effectiveness compared to usual care
Timepoint [7] 388042 0
At completion of patient participation at 2 year time point. We will also evaluate the cost-effectiveness of the e-PROM tools by quantifying: (a) the costs of the intervention and all healthcare interactions (using data from QHAPDC, QHNAPDC, EDIS, MBS, PBS, NCDC) and (b) the benefits of the intervention measured as quality-adjusted life years using EQ-5D-5L.

Eligibility
Key inclusion criteria
Age at least 18 years
diagnosed with invasive solid cancer
about to start or recently started treatment at one of the study sites
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A tumour type or characteristic that is not appropriate for inclusion at the discretion of the Site Investigator and Coordinating PI e.g.:
o Will not return to the site for regular treatment/follow-up
o Already using or would normally use an e-PROM tool at that site
• Treated with surgery only
• Current participation in another study that requires completion of similar PROMs
• Unable to provide informed consent
• Unable to complete the e-PROM tools remotely (e.g. a comorbid condition affecting vision, cognition or dexterity or no internet access at home)
• Unable to complete the study questionnaires in English
• Unwilling to consent to data linkage
In addition, participants who consent but do not complete the Baseline Study Questionnaire will be excluded post-consent.

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)
Randomisation will be at the patient level, with a 1:1 ratio between groups, Allocation concealment will occur using central randomisation by phone/fax/computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using randomly varied permuted blocks, stratified by sex, hospital, cancer type, treatment intent (curative/palliative) and computer literacy (defined as regular access to a computer and use of email >=1/week vs. less often) as this was shown to be important in previous trials. When a participant completes the Baseline Study Questionnaire, the central web-based database will automatically apply the next relevant record in the allocation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Our sample-size has been calculated to achieve a minimum 80% power (a=0.05) for our primary outcomes.
- Emergency presentations (measured from linked data that will be close to complete): Previous studies have reported reductions of 17-30% (Basch, E., et al., Symptom monitoring with patient-reported outcomes during routine cancer treatment: A randomized controlled trial. J Clin Oncol, 2016. 34(6): p. 557-65). Assuming a similar baseline rate (1.09/person-year), we require 242 participants per group to detect a 20% reduction with 18 months follow-up.
- HR-QOL: To detect minimally-important differences (where there is no defined minimally-important difference we have used 0.5 standard deviations as recommended (Norman, G.R., J.A. Sloan, and K.W. Wyrwich, The truly remarkable universality of half a standard deviation: confirmation through another look. Expert Rev Pharmacoecon Outcomes Res, 2004. 4(5): p. 581-5.) we require 70-150 patients per group depending on the outcome. A sample of 200 per group will give >90% power for the primary outcomes in the full population and ~80% power for analyses stratified by e-PROM tool.
Allowing for up to 30% drop-outs (death or withdrawal), we will recruit a minimum of 572 participants (286 per group). We estimate that more than 2000 eligible patients will attend the study hospitals during a 12-month period (data from the Queensland Oncology Analysis System) thus this target is feasible.
Data analysis will be guided by a formal statistical analysis plan that will be finalised prior to any analyses being conducted. All analyses will be intention-to-treat but compliance with the intervention will be assessed and, if there is substantial non-compliance, per-protocol analyses will also be performed. In exploratory sub-group analyses, we will also conduct analyses stratified by e-PROM tool, study site, gender, computer literacy, cancer type and cancer stage (early vs. advanced).
To preserve the blinding during preliminary analyses, the Data Manager will generate datasets with participants’ true allocation code replaced by a random dummy code. This will be replaced by the true code when we perform the final analyses.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
25/01/2021
Actual
14/09/2021
Date of last participant enrolment
Anticipated
30/06/2023
Actual
30/06/2023
Date of last data collection
Anticipated
2/02/2028
Actual
Sample size
Target
580
Accrual to date
Final
600
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17266 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 17267 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 17268 0
The Townsville Hospital - Douglas
Recruitment hospital [4] 17269 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 30979 0
4029 - Herston
Recruitment postcode(s) [2] 30980 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 30982 0
4215 - Southport
Recruitment postcode(s) [4] 30981 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 306471 0
Charities/Societies/Foundations
Name [1] 306471 0
Cancer Council Queensland
Country [1] 306471 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
QIMR Berghofer Medical Research Institute
Address
300 Herston Rd
Herston Qld 4006
Country
Australia
Secondary sponsor category [1] 306994 0
None
Name [1] 306994 0
Address [1] 306994 0
Country [1] 306994 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306679 0
Metro South Health Service District Human Research Ethics Committee
Ethics committee address [1] 306679 0
Centres for Health Research
Level 7, Translational Research Institute Building
Princess Alexandra Hospital
Ipswich Road, Woolloongabba Qld 4102
Ethics committee country [1] 306679 0
Australia
Date submitted for ethics approval [1] 306679 0
13/08/2020
Approval date [1] 306679 0
25/09/2020
Ethics approval number [1] 306679 0

Summary
Brief summary
This study is investigating whether routine collection of patient-reported outcome measures electronically at regular timepoints will have an impact on cancer patients symptoms and the number of hospital admissions.

Who is it for?
You may be eligible for this study if you are 18 or older, you have been diagnosed with an invasive solid cancer and you are about to start or have recently started treatment at one of the study hospitals in Queensland.

Study details
Participants enrolled in this study will be allocated to one of two study groups by chance. Participants allocated to the first group will be asked to complete a short questionnaire about their symptoms and any treatment side effects experienced, prior to each treatment visit using a tablet or other electronic device, and again before follow-up visits with their doctor. It is anticipated that filling in the questionnaire will take about 10 minutes. Participants allocated to the second group won't be asked to complete any questionnaires prior to their treatment or follow-up visits, however, they will be asked you to complete questionnaires at regular time points over a 2 year period from consenting to the study.
Two pre-planned sub-studies will assess the effects of the electronic symptom and treatment questionnaires on participants’ partners and/or carers (PROMISE-Carers Substudy) and the relationship between genetic factors and symptoms/wellbeing/outcomes (PROMISE-Genetics Substudy).

It is hoped this research will determine whether additional collection of patient symptoms and any treatment side effects will result more effective cancer patient care and have a positive impact on unplanned hospital presentations/admissions. Two pre-planned sub-studies will assess the effects of the electronic symptom and treatment questionnaires on participants’ partners and/or carers (PROMISE-Carers Substudy) and the relationship between genetic factors and symptoms/wellbeing/outcomes (PROMISE-Genetics Substudy).
Trial website
www.qimrberghofer.edu.au/promise-study
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104646 0
Prof Penelope Webb
Address 104646 0
QIMR Berghofer Medical Research Institute
300 Herston Rd
Herston QLD 4006
Country 104646 0
Australia
Phone 104646 0
+61 7 3362 0281
Fax 104646 0
+61 7 3845 3503
Email 104646 0
Penny.webb@qimrberghofer.edu.au
Contact person for public queries
Name 104647 0
Prof Penelope Webb
Address 104647 0
QIMR Berghofer Medical Research Institute
300 Herston Rd
Herston QLD 4006
Country 104647 0
Australia
Phone 104647 0
+61 7 3362 0281
Fax 104647 0
+61 7 3845 3503
Email 104647 0
Penny.webb@qimrberghofer.edu.au
Contact person for scientific queries
Name 104648 0
Prof Penelope Webb
Address 104648 0
QIMR Berghofer Medical Research Institute
300 Herston Rd
Herston QLD 4006
Country 104648 0
Australia
Phone 104648 0
+61 7 3362 0281
Fax 104648 0
+61 7 3845 3503
Email 104648 0
Penny.webb@qimrberghofer.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
Confidentiality
Consent is only for the current study


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8969Ethical approval    Uploaded 380397-(Uploaded-21-10-2020-13-46-54)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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