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Trial registered on ANZCTR


Registration number
ACTRN12621000261819
Ethics application status
Approved
Date submitted
7/01/2021
Date registered
10/03/2021
Date last updated
28/02/2023
Date data sharing statement initially provided
10/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Pilot Study Exploring the potential benefits of Nursing Case Management In the Management of older Patients with Myeloma
Scientific title
investigating the patient reported outcomes and medication compliance of newly diagnosed and relapsed patients with myeloma aged 65 and older under the case management of a nurse specialist led program.
Secondary ID [1] 303116 0
Ni known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myeloma 320214 0
Condition category
Condition code
Cancer 318151 318151 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The myeloma nurse will provide a first point of contact, provide patient education about disease and its treatment, and provide early intervention for adverse events.
The nurse will:
• Initially have regular contact (each chemotherapy cycle ±1 week with patients by phone and/or face-to-face to build a relationship of trust. Anticipated duration of initial contact will be up to 30mins and review/follow up 10 minutes. Formal letters will notify patients of upcoming activities to manage their health (e.g. appointments, blood testing, treatment, and referrals);
• Support patients around issues of transport and accommodation (this will be undertaken in additional review sessions of 10 minutes as needed or within initial 30 minute consultation).
• Support patients when in the hospital (if required); and
• Collaborate with the laboratory research staff regarding patient samples
• Multidisciplinary Team (MDT) organisation (The nurse specialist will contact allied health and other members of the team post patient reviews for additional advice if care needs flagged and make additional contact with patient to report advice, outcomes and referrals).

The nurse specialist will allocate time each week (approximately 1 hr each day to track patient on electronic medical records and monitor encounters with the health care system). The nurse will have routine review sessions at the commencement of each oral therapy cycle and as needed throughout the duration of the study. QOL surveys (My-POS https://academy.myeloma.org.uk/resources/mypos/) will be conducted at these routine sessions and recorded by the nurse specialist. All hospital presentations will be recorded and if unplanned what contact, if any, was made with the nurse specialist was made prior. Medication compliance will be monitored throughout using a combination of pill counting and routine reminders used in conjunction with personalised treatment schedules.

Patient education will include verbal and written, with the provision of patient education resources from the following

myeloma.org.au
eviq.org.au
myeloma.org.uk
leukaemia.org.au
cancer.org.au
Intervention code [1] 319416 0
Treatment: Other
Comparator / control treatment
An historical reference group will be taken from the existing Royal Adelaide Hospital paraproteinaemia database. This group will comprise newly diagnosed patients 65years in age and older from 2018 onwards.
Control group
Historical

Outcomes
Primary outcome [1] 326137 0
• The percentage of patient discontinuation of treatment due to toxicity (with nurse led intervention program) over a period of 12 months. Information will be taken from clinical records.
Timepoint [1] 326137 0
At any time within 12 months post enrolment
Primary outcome [2] 326352 0
The percentage of patient discontinuation of treatment due to intolerance (with nurse led intervention program) over a period of 12 months. Information will be taken from clinical records.
Timepoint [2] 326352 0
At any time within 12 months post enrolment
Secondary outcome [1] 390225 0
• To measure the effectiveness of such a nurse led intervention program on disease control assessed by treatment compliance and Myeloma disease markers.

Timepoint [1] 390225 0
assessed at enrolment of participant, then at 6 monthly intervals up to 36 months post enrolment
Secondary outcome [2] 392339 0
To measure the effectiveness of the nurse led intervention on overall survival. This will be assessed by accessing clinical records.
Timepoint [2] 392339 0
assessed at enrolment of participant, then at 6 monthly intervals up to 36 months post enrolment
Secondary outcome [3] 392340 0
To measure the effectiveness of the nurse led intervention program on resource utilisation. This will be assessed by recording the amount and type of referrals for patients monitored by the nurse specialist.
Timepoint [3] 392340 0
assessed at enrolment of participant, then at 6 monthly intervals up to 36 months post enrolment
Secondary outcome [4] 392341 0
To measure the effectiveness of the nurse led intervention program on patient reported quality of life. This will be assessed using a nationally recognised patient reported outcome questionnaire (My-Pos)
Timepoint [4] 392341 0
Assessed at enrolment of participant, then at 6 monthly intervals up to 36 months post enrolment
Secondary outcome [5] 392342 0
To assess planned and unplanned health care presentations (GP, ED, hospital admissions) while being managed by a nurse specialist. This will be assessed by viewing medical records and participant reports.
Timepoint [5] 392342 0
Continuously throughout the 36 month time period whenever a presentation occurs.

Eligibility
Key inclusion criteria
• Diagnosis of Myeloma according to the WHO (2008) classification, aged 65years and over
• MGUS patients progressed to Myeloma needing treatment
• Relapsed Myeloma patients needing treatment
• Capacity to understand and voluntarily sign an informed consent form
• Able to be followed at the Royal Adelaide Hospital/The Queen Elizabeth Hospital
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Primary Haematologist does not practice at the Royal Adelaide Hospital/ The Queen Elizabeth Hospital
• patients <65 years of age
• Any significant condition that would confound the collection or interpretation of data from the study

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)
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/02/2021
Date of last participant enrolment
Anticipated
28/12/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
150
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 307523 0
Commercial sector/Industry
Name [1] 307523 0
BMS-celgene
Country [1] 307523 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
BMS-celgene
Address
Level 2/4 Nexus Court
Mulgrave VIC 3170
Australia
Country
Australia
Secondary sponsor category [1] 308202 0
None
Name [1] 308202 0
Address [1] 308202 0
Country [1] 308202 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307590 0
Central Adelaide Local Health Network Research Ethics Committee
Ethics committee address [1] 307590 0
Ethics committee country [1] 307590 0
Australia
Date submitted for ethics approval [1] 307590 0
21/06/2020
Approval date [1] 307590 0
13/07/2020
Ethics approval number [1] 307590 0
13393

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

Contacts
Principal investigator
Name 107782 0
Dr Cindy Lee
Address 107782 0
Royal Adelaide Hospital
Haematology
Port Rd
Adelaide
SA 5000
Country 107782 0
Australia
Phone 107782 0
+61 8 7074 2356
Fax 107782 0
Email 107782 0
Cindy.Lee3@sa.gov.au
Contact person for public queries
Name 107783 0
Cindy Lee
Address 107783 0
Royal Adelaide Hospital
Haematology
Port Rd
Adelaide
SA 5000
Country 107783 0
Australia
Phone 107783 0
+61 8 7074 2356
Fax 107783 0
Email 107783 0
Cindy.Lee3@sa.gov.au
Contact person for scientific queries
Name 107784 0
Cindy Lee
Address 107784 0
Royal Adelaide Hospital
Haematology
Port Rd
Adelaide
SA 5000
Country 107784 0
Australia
Phone 107784 0
+61 8 7074 2356
Fax 107784 0
Email 107784 0
Cindy.Lee3@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual patient data will be shared outside the investigator team.

Collated de-identified aggregate data will be made available to BMS-Celgene who have provided funding for this project. No individual patient data will be provided to BMS-Celgene.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10187Study protocol  sophie.wilson@sa.gov.au
10188Informed consent form  sophie.wilson@sa.gov.au
10189Ethical approval  sophie.wilson@sa.gov.au



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.