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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
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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.
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Secondary ID [1]
303116
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Ni known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myeloma
320214
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Condition category
Condition code
Cancer
318151
318151
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0
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Myeloma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
319416
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Treatment: Other
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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.
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Control group
Historical
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Outcomes
Primary outcome [1]
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• 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.
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Assessment method [1]
326137
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Timepoint [1]
326137
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At any time within 12 months post enrolment
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Primary outcome [2]
326352
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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.
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Assessment method [2]
326352
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Timepoint [2]
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At any time within 12 months post enrolment
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Secondary outcome [1]
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• To measure the effectiveness of such a nurse led intervention program on disease control assessed by treatment compliance and Myeloma disease markers.
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Assessment method [1]
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Timepoint [1]
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assessed at enrolment of participant, then at 6 monthly intervals up to 36 months post enrolment
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Secondary outcome [2]
392339
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To measure the effectiveness of the nurse led intervention on overall survival. This will be assessed by accessing clinical records.
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Assessment method [2]
392339
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Timepoint [2]
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assessed at enrolment of participant, then at 6 monthly intervals up to 36 months post enrolment
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Secondary outcome [3]
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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.
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Assessment method [3]
392340
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Timepoint [3]
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assessed at enrolment of participant, then at 6 monthly intervals up to 36 months post enrolment
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Secondary outcome [4]
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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)
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Assessment method [4]
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Timepoint [4]
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Assessed at enrolment of participant, then at 6 monthly intervals up to 36 months post enrolment
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Secondary outcome [5]
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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.
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Assessment method [5]
392342
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Timepoint [5]
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Continuously throughout the 36 month time period whenever a presentation occurs.
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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
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
17/02/2021
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Date of last participant enrolment
Anticipated
28/12/2023
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
150
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Accrual to date
150
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
307523
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Commercial sector/Industry
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Name [1]
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BMS-celgene
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Address [1]
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Level 2/4 Nexus Court
Mulgrave VIC 3170
Australia
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
BMS-celgene
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Address
Level 2/4 Nexus Court
Mulgrave VIC 3170
Australia
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Country
Australia
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Secondary sponsor category [1]
308202
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None
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Name [1]
308202
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Address [1]
308202
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Country [1]
308202
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
307590
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Central Adelaide Local Health Network Research Ethics Committee
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Ethics committee address [1]
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Royal Adelaide Hospital Clinical Trial Centre Level 3 Port Road Adelaide SA 5000
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Ethics committee country [1]
307590
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Australia
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Date submitted for ethics approval [1]
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21/06/2020
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Approval date [1]
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13/07/2020
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Ethics approval number [1]
307590
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13393
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Summary
Brief summary
This study is investigating the perceived benefit of implementing a nurse led model of care for older myeloma patients undergoing oral cancer treatment. Who is it for? You may be eligible for this study if you are aged 65 years or older, you are newly diagnosed with Myeloma or first relapse and are being treated at one of the participating hospitals in South Australia. Study details All enrolled participants will be provided with additional education about the disease and treatment by a specialist nurse. The specialist nurse will also act as a first point of contact during chemotherapy to answer questions and provide additional support to participants as required. Participants will have their medical records reviewed by the specialist nurse and may be asked to complete questionnaires at various timepoints over a 12 month period. It is hoped this research will demonstrate that a nurse led model of care for older patients with myeloma has a positive impact on their treatment completion rates and quality of life during cancer treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Cindy Lee
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Address
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Royal Adelaide Hospital
Haematology
Port Rd
Adelaide
SA 5000
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Country
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Australia
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Phone
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+61 8 7074 2356
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Cindy Lee
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Address
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Royal Adelaide Hospital
Haematology
Port Rd
Adelaide
SA 5000
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Country
107783
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Australia
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Phone
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+61 8 7074 2356
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Fax
107783
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Email
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[email protected]
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Contact person for scientific queries
Name
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Cindy Lee
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Address
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Royal Adelaide Hospital
Haematology
Port Rd
Adelaide
SA 5000
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Country
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Australia
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Phone
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+61 8 7074 2356
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Fax
107784
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Email
107784
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
10187
Study protocol
[email protected]
10188
Informed consent form
[email protected]
10189
Ethical approval
[email protected]
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.
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