Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000530527p
Ethics application status
Submitted, not yet approved
Date submitted
2/04/2024
Date registered
29/04/2024
Date last updated
29/04/2024
Date data sharing statement initially provided
29/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of co-designed ‘Making-it-Meaningful’ tool with consumers accessing an Australian cancer service.
Scientific title
Pilot study of co-designed ‘Making-it-Meaningful’ tool with consumers accessing an Australian cancer service.
Secondary ID [1] 311859 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a sub-study to registration record ACTRN12622001260718.

Health condition
Health condition(s) or problem(s) studied:
medication communication in cancer care 333406 0
Medication literacy 333407 0
Condition category
Condition code
Cancer 330087 330087 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MiM is a two-page medication management tool that provides patient with information about common-side effects of the medication and the appropriate contact person to reach out if they have any questions or concerns about their medications, appointment, treatment or medication side effects. The MiM was co-designed with patients and clinicians from Australian cancer services. Three co-design workshops, each lasting for approximately two and half hours were conducted over a period of three weeks. In first workshop, participant democratically selected the issue of medication safety in outpatient setting to address. In second workshop, brainstormed various strategies to address the issue and in the third and final workshop, the prototype for MIM was developed. This prototype was further refined with email feedback from participants. The process of developing the MiM is described in a peer-reviewed publication available through the following link - https://pxjournal.org/cgi/viewcontent.cgi?article=1732&context=journal

Participants allocated to the intervention group will attend their usual consultation or appointment. The health practitioner will use the MiM along with the usual care to facilitate communication about medication management at the consultation and provide a paper copy of the MiM for the patient to take away with them. Participants will take part in verbal phone surveys at three time points (before the consultation, a week after the consultation and a month after the consultation).



Intervention code [1] 328320 0
Treatment: Other
Comparator / control treatment
Participants allocated to the control group will receive usual care from their health care practitioner, which includes communication about medications using the existing medication management tool available in the participating service. At the participating site, patients are provided information from eviQ resource page. No other printed information is provided to the patients for who to contact if they have any concerns.

Participants will take part in a verbal phone survey at three time points (before the consultation, a week after the consultation and a month after the consultation. .
Control group
Active

Outcomes
Primary outcome [1] 337842 0
Knowledge of medication management at home.

This outcome will be measured using an 11-item survey. More details provided in Assessment method. The survey is published and is available via link - https://www.researchprotocols.org/2023/1/e49902
Timepoint [1] 337842 0
The survey will be conducted at three time points. One week prior to the appointment with the medical practitioner, one week after appointment with the medical practitioner when intervention/control was delivered and at four weeks mark after the delivery of the intervention/control.
Primary outcome [2] 337938 0
Self-efficacy in medication management at home.
Timepoint [2] 337938 0
The survey will be conducted at three time points. One week prior to the appointment with the medical practitioner, one week after appointment with the medical practitioner when intervention/control was delivered and at four weeks mark after the delivery of the intervention/control.
Primary outcome [3] 337939 0
Patient engagement in medication management
Timepoint [3] 337939 0
The survey will be conducted at three time points. One week prior to the appointment with the medical practitioner, one week after appointment with the medical practitioner when intervention/control was delivered and at four weeks mark after the delivery of the intervention/control.
Secondary outcome [1] 433444 0
To investigate the suitability of recruitment, retention and data collection processes and materials for a large study. This will be assessed as a composite outcome.
Timepoint [1] 433444 0
The survey will be conducted at three time points. One week prior to the appointment with the medical practitioner, one week after appointment with the medical practitioner when intervention/control was delivered and at four weeks mark after the delivery of the intervention/control.

Eligibility
Key inclusion criteria
Inclusion and exclusion criteria for patients:
• Outpatients receiving treatment and care at Macquarie Health cancer service.
• Be 18 years or older.
• Self-identify as from Mandarin or English-speaking background.
• Willing to give written consent and participate in the study.

Inclusion criteria for health practitioners.
• Employed at MQ Health cancer service.
• Have used the MiM tool.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for patients
• People who experience a sudden deterioration in health where participation would be considered an undue burden.

Exclusion criteria for healthcare staff:
• Staff who have not used the MIM tool

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed by using a sealed envelop method .
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using sealed envelop method. .
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316203 0
University
Name [1] 316203 0
Macquarie University
Country [1] 316203 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 318387 0
None
Name [1] 318387 0
Address [1] 318387 0
Country [1] 318387 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315020 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 315020 0
https://www.mq.edu.au/research/ethics-integrity-and-policies/ethics/human-ethics
Ethics committee country [1] 315020 0
Australia
Date submitted for ethics approval [1] 315020 0
08/04/2024
Approval date [1] 315020 0
Ethics approval number [1] 315020 0

Summary
Brief summary
The purpose of this study is to test out a consumer engagement strategy called Making it Meaningful (MiM). The MiM has been designed for people who use cancer services and may be undergoing a change in their medications.

Eligibility criteria:
Outpatients who are receiving treatment or care at participating cancer service and aged 18 years or older will be eligible to take part. Patients who attend the service must identify their primary language as English or Mandarin to be eligible to participate

Study details
Participants who choose to enroll in this study will be randomly allocated to either receive the MiM medication management tool, or to receive standard care provided by the cancer service. Participants who are allocated to the MiM group will attend an appointment with their health practitioner (medical practitioner) who will use the Make it Meaningful Tool (MiM) to facilitate communication at the individual appointment where medications are changed. It is anticipated that this appointment will take no longer than your usual consultation. The health care practitioner will provide a paper copy of the MiM for the patient to take away from the appointment. The health care practitioner will also provide instructions to the patient about how the tool can be used to inform them of who to contact if they have any concerns about medication, treatment or experience side effects, etc..

Participants who are allocated to the standard care group will not receive the MiM tool, they will instead discuss the medication management together with their health care practitioner using the usual care strategy currently provided. All participants will be asked to complete a series of questionnaires over the phone when they first agree to participate in the study, 1 week and then 4 weeks after the medication discussion with their health care practitioner. It is expected that completion of these questionnaires will take 15 minutes.

It is hoped this research will determine that use of the MiM tool is practical and acceptable to cancer patients. If this small study shows that the MiM tool is helpful for cancer patients, it may be studied further in a larger trial that may lead to improvements in medication communication for cancer patients in the future
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133446 0
Dr Ashfaq Chauhan
Address 133446 0
Level 6, 75 Talavera Road, Macquarie University NSW 2109
Country 133446 0
Australia
Phone 133446 0
+61298502460
Fax 133446 0
Email 133446 0
ashfaq.chauhan@mq.edu.au
Contact person for public queries
Name 133447 0
Ashfaq Chauhan
Address 133447 0
Level 6, 75 Talavera Road, Macquarie University NSW 2109
Country 133447 0
Australia
Phone 133447 0
+61298502460
Fax 133447 0
Email 133447 0
ashfaq.chauhan@mq.edu.au
Contact person for scientific queries
Name 133448 0
Ashfaq Chauhan
Address 133448 0
Level 6, 75 Talavera Road, Macquarie University NSW 2109
Country 133448 0
Australia
Phone 133448 0
+61298502460
Fax 133448 0
Email 133448 0
ashfaq.chauhan@mq.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


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.