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Trial registered on ANZCTR


Registration number
ACTRN12622001457730
Ethics application status
Approved
Date submitted
3/11/2022
Date registered
15/11/2022
Date last updated
10/12/2023
Date data sharing statement initially provided
15/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Real-time patient-reported outcomes measures (PROMs) and patient-reported experience measures (PREMS) in oncology: exploring inclusivity and toward a new standard of care.
Scientific title
Real-time patient-reported outcomes measures (PROMs) and patient-reported experience measures (PREMS) in oncology: exploring inclusivity and toward a new standard of care.
Secondary ID [1] 308209 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 328121 0
Condition category
Condition code
Cancer 325176 325176 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete short PROMs and PREMs questionnaires on an electronic device up to 2 days prior to routine clinical consultations in selected outpatient oncology clinics, either in their own home or in the clinic waiting room. These questionnaires will ask about common cancer-related symptoms, quality of life, and supportive care needs. Treating clinicians will review questionnaire responses as part of their patient assessment and may use them to guide clinical care.

Participants will be sent a link to an online questionnaire 2 days prior to their scheduled appointment and can complete the questionnaire on a personal electronic device. Participants who do not have access to a suitable device and attending in person may complete the questionnaire on a provided iPad in the clinic waiting room. In each case, a research officer will be available to assist participants with questionnaire completion if needed. The questionnaires will be available in English and also translated into 10 commonly spoken languages. They will take approximately 10-15 minutes to complete and will be administered prior to each scheduled clinic appointment. The frequency of questionnaire administration will be determined by the patient's routine clinical review schedule, which will vary between participants. There will be no additional visits to the clinics over and above usual care for this study.

The research officer will audit consultation time pre- and post-intervention to assess the impact of routine PROMS and PREMS on clinic flow. All patients attending the clinic will be offered the intervention, and a log kept of those who decline to participate including the reasons given (if any).
Intervention code [1] 324781 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333002 0
Prevalence of symptoms among oncology outpatient clinic attendees as measured by the Edmonton Symptom Assessment System (ESAS).
Timepoint [1] 333002 0
First clinic attendance during study period.
Primary outcome [2] 333003 0
Self-rated health among oncology outpatient clinic attendees as measured by the EQ-5D.
Timepoint [2] 333003 0
First clinic attendance during study period.
Primary outcome [3] 333004 0
Prevalence of unmet supportive care needs among oncology outpatient clinic attendees as measured by the Supportive Care Needs Survey - Short Form 34 (SCNS-SF34).
Timepoint [3] 333004 0
First clinic attendance during study period.
Secondary outcome [1] 415510 0
Change in symptom severity over time as measured by the ESAS.
Timepoint [1] 415510 0
Assessed at each routine oncology clinic attendance during the 6 month intervention period.

(Note that the frequency of attendances will vary between participants and will be determined by the clinical care needs of each patient. There are no study specific visits over and above usual care).
Secondary outcome [2] 415511 0
Change in self-rated health over time as measured by the EQ-5D.
Timepoint [2] 415511 0
Assessed at each routine oncology clinic attendance during the 6 month intervention period.

(Note that the frequency of attendances will vary between participants and will be determined by the clinical care needs of each patient. There are no study specific visits over and above usual care).
Secondary outcome [3] 415512 0
Change in supportive care needs over time as measured by the SCNS-SF34.
Timepoint [3] 415512 0
Assessed at each routine oncology clinic attendance during the 6 month intervention period.

(Note that the frequency of attendances will vary between participants and will be determined by the clinical care needs of each patient. There are no study specific visits over and above usual care).
Secondary outcome [4] 415513 0
Unplanned inpatient admissions, as recorded in medical records.
Timepoint [4] 415513 0
Assessed at each routine oncology clinic attendance during the 6 month intervention period.

(Note that the frequency of attendances will vary between participants and will be determined by the clinical care needs of each patient. There are no study specific visits over and above usual care).
Secondary outcome [5] 415515 0
Emergency department attendances, as recorded in medical records.
Timepoint [5] 415515 0
Assessed at each routine oncology clinic attendance during the 6 month intervention period.

(Note that the frequency of attendances will vary between participants and will be determined by the clinical care needs of each patient. There are no study specific visits over and above usual care).
Secondary outcome [6] 415517 0
Number of referrals to allied health and other supportive care services (composite endpoint), as recorded in medical records.
Timepoint [6] 415517 0
Assessed at each routine oncology clinic attendance during the 6 month intervention period.

(Note that the frequency of attendances will vary between participants and will be determined by the clinical care needs of each patient. There are no study specific visits over and above usual care).
Secondary outcome [7] 415519 0
Average consultation time, measured from time patient called into clinic room by a doctor to time returned to waiting room, as observed and logged by the research assistant.
Timepoint [7] 415519 0
Opportunistic sampling of clinic appointments at three timepoints: 4 weeks prior to intervention period, 4 weeks at beginning of intervention period and 4 weeks at end of intervention period.
Secondary outcome [8] 415521 0
Feasibility and acceptability of both real-time and remote PROM and PREM collection and use to participants, as determined by patient participant evaluation surveys and focus group interviews. The survey instrument has been designed specifically for this study.
Timepoint [8] 415521 0
One month pre-intervention and one month post-intervention.
Secondary outcome [9] 415522 0
Feasibility and acceptability of both real-time and remote PROM and PREM collection and use to clinicians and administration staff, as determined by healthcare team staff interviews.
Timepoint [9] 415522 0
One month pre-intervention and one month post-intervention.
Secondary outcome [10] 415523 0
Feasibility and acceptability of collection and use of translated PROM and PREM to participants whose preferred language is not English, as determined by patient participant evaluation surveys and focus group interviews. The survey instrument has been designed specifically for this study.
Timepoint [10] 415523 0
One month pre-intervention and one month post-intervention.

Eligibility
Key inclusion criteria
Adults with a diagnosis of cancer attending Monash Health outpatient oncology clinics.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who speak a language other than English or the 10 non-English languages that the PROMs and PREMs questionnaires will be translated into, will not be included in this study unless a caregiver or an interpreter can assist with completing the PROMs and PREMs.

Additionally, patients who do not have a personal electronic device to complete the questionnaires and who will be attending their scheduled clinic appointment via telephone, will not be included in this study unless a caregiver can assist with completing the PROMs and PREMs on their device.

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)
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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
28/11/2022
Actual
22/02/2023
Date of last participant enrolment
Anticipated
1/07/2023
Actual
31/08/2023
Date of last data collection
Anticipated
29/02/2024
Actual
Sample size
Target
400
Accrual to date
Final
464
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23492 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 38899 0
3165 - East Bentleigh

Funding & Sponsors
Funding source category [1] 312466 0
Other Collaborative groups
Name [1] 312466 0
Southern Melbourne Integrated Cancer Service
Country [1] 312466 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Rd
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 314047 0
None
Name [1] 314047 0
Address [1] 314047 0
Country [1] 314047 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311811 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 311811 0
Ethics committee country [1] 311811 0
Australia
Date submitted for ethics approval [1] 311811 0
24/08/2022
Approval date [1] 311811 0
11/11/2022
Ethics approval number [1] 311811 0
RES-22-0000-530A

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

Contacts
Principal investigator
Name 122446 0
Dr Kate Webber
Address 122446 0
Oncology Research, Monash Health and Monash University
Level 7 MHTP Building
246 Clayton Rd
Clayton Vic 3168
Country 122446 0
Australia
Phone 122446 0
+613 85722392
Fax 122446 0
Email 122446 0
kate.webber@monashhealth.org
Contact person for public queries
Name 122447 0
Kate Webber
Address 122447 0
Oncology Research, Monash Health and Monash University
Level 7 MHTP Building
246 Clayton Rd
Clayton Vic 3168
Country 122447 0
Australia
Phone 122447 0
+613 85722392
Fax 122447 0
Email 122447 0
kate.webber@monashhealth.org
Contact person for scientific queries
Name 122448 0
Kate Webber
Address 122448 0
Oncology Research, Monash Health and Monash University
Level 7 MHTP Building
246 Clayton Rd
Clayton Vic 3168
Country 122448 0
Australia
Phone 122448 0
+613 85722392
Fax 122448 0
Email 122448 0
kate.webber@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.