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Trial registered on ANZCTR


Registration number
ACTRN12620000667910
Ethics application status
Approved
Date submitted
11/03/2020
Date registered
11/06/2020
Date last updated
11/06/2020
Date data sharing statement initially provided
11/06/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing Outpatient and Inpatient Autologous Stem Cell Transplant in Patients with Multiple Myeloma
Scientific title
A Study of Outpatient Compared to Inpatient Autologous Stem Cell Transplant in a Resource Constrained Environment at Nepean Hospital

Secondary ID [1] 300763 0
Nil Known
Universal Trial Number (UTN)
Nil
Trial acronym
CompareASCT
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Autologous Stem Cell Transplant 316615 0
Condition category
Condition code
Cancer 314843 314843 0 0
Myeloma
Public Health 315445 315445 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standard pre-transplant chemotherapy with Melphalan will be provided by an outpatient cancer nurse the day prior to the autologous transplant in the cancer centre.
Autologous stem cell transplant will be provided by an outpatient cancer nurse in the cancer centre the day after the chemotherapy.
Post transplant supportive care in the outpatient setting will occur at the cancer centre and in the patient's home; patient's will complete a daily diary to assist with monitoring their condition (the diary records fluid input and output, temperature recordings, medication and food intake), patient's will visit the cancer centre every second day from the transplant onwards (not including weekends) and be phoned by centre staff on alternate days, bloods will be taken and checked on average every 2 days, intravenous fluids/blood products/medication will be provided on visits to the cancer centre as required. No health professional will visit the patient's home. All this will occur for a minimum of 12 days post transplant, and a maximum of 28 days post transplant.
A comparison will be made to pre-transplant chemotherapy, autologous stem cell transplant, and post transplant supportive care in the inpatient setting at Nepean Hospital.
This study will span 7 weeks for each participant.
Intervention code [1] 317092 0
Treatment: Other
Comparator / control treatment
Current standard of care is inpatient pre-transplant chemotherapy, autologous stem cell transplant and post transplant supportive care.
Control group
Active

Outcomes
Primary outcome [1] 323196 0
Proportion of Autologous Stem Cell Transplant participants with a reduction in hospital stay.
Measured by; Number of admissions to hospital and length of stay for each participant. All this data will be collected from patient medical records.
Timepoint [1] 323196 0
From day -2 through to 6 week post transplant visit for each participant
Secondary outcome [1] 381138 0
Measurement of health related quality of life..
Assessed via the;Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT).
Timepoint [1] 381138 0
Baseline (day-2), Transplant Day +5, day +13/16 and 6 weeks post transplant visit for FACT-BMT.
Secondary outcome [2] 381139 0
Alteration in episodes of febrile neutropenia in the outpatient group.
Assessed through monitoring of occasions of service, utilising data from patient medical records.
Timepoint [2] 381139 0
Baseline to 6 week post transplant visit.
Secondary outcome [3] 381140 0
Comparison of safety profiles between outpatient and inpatient groups.
Assessed through; rates of hospitalisation, number of infections, blood product requirements, Intensive Care admissions, antibiotic utilisation and engraftment dates, data will be collected from patient medical records.
Timepoint [3] 381140 0
Baseline to 6 weeks post transplant follow up visit
Secondary outcome [4] 381141 0
Compare carer burden between inpatient and outpatient groups.
Determined by scoring the Caregiver Quality of Life - Cancer survey.
Timepoint [4] 381141 0
Baseline, day +5, day 13-16 and 6 week post transplant.
Secondary outcome [5] 381143 0
Functional status.
Assessed by ECOG
Timepoint [5] 381143 0
baseline, day+5, day +13-16 and 6 weeks post transplant visit.
Secondary outcome [6] 383028 0
Monitor anxiety levels in participants
Timepoint [6] 383028 0
Hospital Anxiety and Depression scale (HADS) will be completed by all participants prior to transplantation (baseline) and then reapplied if the initial score is 8 or above at day +5, day+13-16 and 6 weeks post transplant.
Secondary outcome [7] 383029 0
Monitor participants fatigue levels
Timepoint [7] 383029 0
Fatigue Symptom Inventory (FIS) will be measured day -2, day +5, day +13-16 and 6 weeks post Day 0

Eligibility
Key inclusion criteria
diagnosis of multiple myeloma
to be treated with Melphalan pre-transplant
ECOG 0,1,or 2
Fit for autologous stem cell transplant at Nepean Hospital
Participant willing to participate in the trial
carer available
transport and driver available
complies with cohort distance requirements
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not fit for Autologous stem cell transplant
Unwilling to participate

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will choose which group they go into.
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis
Total of 30 transplant participants - 15 in each group and their carers.
In comparing the inpatient and outpatient groups Chi-square and Wilcox Rank Sum tests will be used particularly regarding demographic data and treatment related risk factors.
Consideration will be given to differences in the supportive care medication regimes between the two groups.
A two-sample t-test will be used to compare change in Quality Of Life measures at 2-3 weeks from baseline between the two groups. Secondary outcomes will be compared using chi-squared tests or 2-sample t-tests for categorical and continuous data respectively.
An interim analysis will be conducted after 9 participants in each group have completed their 6 week post transplant visit, with a particular focus on adverse events, clinical pathway deviations, hospitalisations, Intensive Care admissions and Quality of Life.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16108 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 29624 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 305224 0
Hospital
Name [1] 305224 0
Nepean Hospital
Address [1] 305224 0
Cnr Great Western Hwy and Somerset St
Kingswood NSW 2747
Country [1] 305224 0
Australia
Primary sponsor type
Government body
Name
Nepean Blue Mountains Local Health District
Address
Cnr Great Western Hwy and Somerset St Kingswood
NSW 2747
Country
Australia
Secondary sponsor category [1] 305582 0
None
Name [1] 305582 0
Address [1] 305582 0
Country [1] 305582 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305571 0
NBMLHD HREC
Ethics committee address [1] 305571 0
2-6 Station St Penrith
NSW 2750
Ethics committee country [1] 305571 0
Australia
Date submitted for ethics approval [1] 305571 0
09/03/2020
Approval date [1] 305571 0
27/05/2020
Ethics approval number [1] 305571 0
2020/ETH00530

Summary
Brief summary
The purpose of this study is to examine the safety of completing a stem cell transplant of your own cells in the outpatient setting.
Who is it for?
You may be eligible for this study if you are aged 18 -75 and are undergoing a stem cell transplant with your own cells at Nepean Hospital.
Study Details
Participants will choose between two locations for their transplant, inpatient or outpatient.
Inpatient participants will receive all pre-transplant, transplant and post transplant care in hospital. Inpatient participants will be discharged when they are well enough.
Outpatient participants will come to the centre for their pre-transplant chemotherapy, transplant and post transplant care but be able to stay at home between visits until they become unwell or require extra care unable to be provided at home. The outpatient participants will also take oral antibiotics after the transplant.
As part of this study, participants and their carers will complete questionnaires and consent to study staff reviewing their medical records.
It is hoped this research will show that stem cell transplant can be performed in an outpatient setting, which may improve quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100814 0
Dr Anita Shetty
Address 100814 0
Nepean Cancer Care Centre
Cnr Great Western Hwy and Somerset St
Kingswood NSW 2747
Country 100814 0
Australia
Phone 100814 0
+61 2 4734 3500
Fax 100814 0
Email 100814 0
anita.shetty@health.nsw.gov.au
Contact person for public queries
Name 100815 0
Ms Elyssa Deakin
Address 100815 0
Nepean Cancer Care Centre
Cnr Great Western Hwy and Somerset St
Kingswood NSW 2747
Country 100815 0
Australia
Phone 100815 0
+61 2 4734 4411
Fax 100815 0
Email 100815 0
elyssa.deakin@health.nsw.gov.au
Contact person for scientific queries
Name 100816 0
Dr Anita Shetty
Address 100816 0
Nepean Cancer Care Centre
Cnr Great Western Hwy and Somerset St
Kingswood NSW 2747
Country 100816 0
Australia
Phone 100816 0
+61 2 4734 3500
Fax 100816 0
Email 100816 0
anita.shetty@health.nsw.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
Data will be collated at site
What supporting documents are/will be available?
No other documents available
Summary results
No Results