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Trial registered on ANZCTR


Registration number
ACTRN12619001470189
Ethics application status
Approved
Date submitted
21/08/2019
Date registered
23/10/2019
Date last updated
17/06/2021
Date data sharing statement initially provided
23/10/2019
Date results information initially provided
17/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Real-time collection and use of patient-reported outcome measures and patient-reported experience measures in an outpatient oncology setting
Scientific title
A pilot study of real-time patient-reported outcomes measures (PROMs) and patient-reported experience measures (PREMS) an outpatient oncology setting
Secondary ID [1] 299088 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 314127 0
Condition category
Condition code
Cancer 312503 312503 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 an outpatient oncology clinic, 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 may complete the questionnaire over the telephone with the assistance of the research officer, or will be provided with an iPad in the clinic waiting room if they attend in person. In each case, a research officer will be available to assist participants with questionnaire completion if needed. The questionnaires 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 no additional visits to clinic 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] 315358 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321136 0
Prevalence of symptoms among oncology outpatient clinic attendees as measured by the Edmonton Symptom Assessment Scale (ESAS)
Timepoint [1] 321136 0
First clinic attendance during study period
Primary outcome [2] 321137 0
Self-rated health among oncology outpatient clinic attendees as measured by the EQ-5D
Timepoint [2] 321137 0
First clinic attendance during study period
Primary outcome [3] 321753 0
Prevalence of unmet supportive care needs among oncology outpatient clinic attendees as measured by the Supportive Care Needs Survey SF-34
Timepoint [3] 321753 0
First clinic attendance during study period
Secondary outcome [1] 374108 0
Change in symptom severity over time as measured by the ESAS
Timepoint [1] 374108 0
Assessed at each routine oncology clinic attendance during the 18 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] 374109 0
Change in self-rated health over time as measured by the EQ-5D
Timepoint [2] 374109 0
Assessed at each routine oncology clinic attendance during the 18 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] 374110 0
Change in supportive care needs over time as measured by the SCNS-SF34.
Timepoint [3] 374110 0
Assessed at each routine oncology clinic attendance during the 18 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] 374111 0
Unplanned inpatient admissions, as recorded in medical records
Timepoint [4] 374111 0
Assessed at each routine oncology clinic attendance during the 18 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] 374112 0
Emergency department attendances, as recorded in medical records.
Timepoint [5] 374112 0
Assessed at each routine oncology clinic attendance during the 18 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] 375922 0
Number of referrals to allied health and other supportive care services (composite endpoint), as recorded in medical records
Timepoint [6] 375922 0
Assessed at each routine oncology clinic attendance during the 18 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] 375923 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] 375923 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] 375924 0
Feasibility and acceptability of real-time PROM and PREM use to participants, as determined by patient participant evaluation survey and telephone interviews. The survey instrument has been designed specifically for this study.
Timepoint [8] 375924 0
One month after completion of the intervention period.
Secondary outcome [9] 376123 0
Feasibility and acceptability of real-time PROM and PREM use to clinicians and administration staff, as determined by clinician focus groups
Timepoint [9] 376123 0
One month pre-intervention and one month post-intervention
Secondary outcome [10] 396936 0
Feasibility and acceptability of remote real-time PROM and PREM collection and use, as determined by patient participant evaluation survey and telephone interviews. The survey instrument has been designed specifically for this study.
Timepoint [10] 396936 0
One month after completion of the intervention period

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 will not be included in this pilot study, unless a caregiver or an interpreter can assist with completing the PROMs and PREMs. However, development of a clear plan for subsequent translation of the intervention to this population is recognised as a high priority.

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
Completed
Date of first participant enrolment
Anticipated
1/11/2019
Actual
13/12/2019
Date of last participant enrolment
Anticipated
Actual
30/04/2021
Date of last data collection
Anticipated
Actual
30/05/2021
Sample size
Target
400
Accrual to date
Final
493
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14608 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 27629 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 303625 0
Other Collaborative groups
Name [1] 303625 0
Monash Partners Comprehensive Cancer Consortium
Country [1] 303625 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Rd
Clayton Vic 3168
Country
Australia
Secondary sponsor category [1] 303717 0
None
Name [1] 303717 0
Address [1] 303717 0
Country [1] 303717 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304151 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 304151 0
Research Support Services
Level 2, i Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 304151 0
Australia
Date submitted for ethics approval [1] 304151 0
21/08/2019
Approval date [1] 304151 0
09/10/2019
Ethics approval number [1] 304151 0

Summary
Brief summary
The purpose of this pilot study is to determine if using the PROMs and PREMs questionnaires in real-time within an outpatient clinic for those with cancer will help to identify patient concerns for immediate discussion and management with their treating teams.

Who is it for?
You may be eligible for this study if you are aged 18 or over, have a diagnosis of cancer and attend a Monash Health medical oncology outpatient clinic.

Study details
All participants in this study will complete a variety of questionnaires about their cancer and treatment experience. There will be study questions relating to cancer symptoms, services for support and your overall quality of life. These questionnaires will be available to complete online up to 2 days prior to routine clinic visits. No additional visits are required for participation in this study.

Participants will also be asked to complete a survey and/or contacted via telephone to evaluate the study at the end of the research period.

It is hoped this research will improve patient oncology services and identify that these questionnaires are feasible, acceptable and useful for patients and doctors in real time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95974 0
Prof Eva Segelov
Address 95974 0
Oncology Research, Monash Health and Monash University
Level 7 MHTP Building
246 Clayton Rd
Clayton Vic 3168
Country 95974 0
Australia
Phone 95974 0
+61385722392
Fax 95974 0
Email 95974 0
eva.segelov@monash.edu
Contact person for public queries
Name 95975 0
Dr Kate Webber
Address 95975 0
Oncology Research, Monash Health and Monash University
Level 7 MHTP Building
246 Clayton Rd
Clayton Vic 3168
Country 95975 0
Australia
Phone 95975 0
+61385722392
Fax 95975 0
Email 95975 0
kate.webber@monash.edu
Contact person for scientific queries
Name 95976 0
Dr Kate Webber
Address 95976 0
Oncology Research, Monash Health and Monash University
Level 7 MHTP Building
246 Clayton Rd
Clayton Vic 3168
Country 95976 0
Australia
Phone 95976 0
+61385722392
Fax 95976 0
Email 95976 0
kate.webber@monash.edu

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.