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Trial registered on ANZCTR


Registration number
ACTRN12615000197538
Ethics application status
Approved
Date submitted
4/02/2015
Date registered
2/03/2015
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of breast cancer patients treated with chemotherapy in a hospital day unit or at home; an analysis of cost and patient reported outcomes
Scientific title
A randomised controlled trial of breast cancer patients treated with chemotherapy in a hospital day unit or at home; an analysis of cost and patient reported outcomes
Secondary ID [1] 286098 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 294100 0
Condition category
Condition code
Cancer 294411 294411 0 0
Breast
Public Health 294480 294480 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Therapeutic intervention - at home chemotherapy treatment administered intravenously by a trained nurse. The treatment is as per usual care. For those randomised to the intervention group, cycles 1 and 2 are delivered in the hospital day unit and cycles 3 and 4 are delivered at home. The intervention duration will be 2 x 2 hour (maximum) cycles (cycles 3 and 4).

It is envisaged that most cycles will be 21 days in length. Treatment in most instances will occur on day 1 only, with 20 days until the next cycle. Hence, day 1 of the next cycle would be day 22 and so on.
Intervention code [1] 291092 0
Treatment: Other
Comparator / control treatment
Standard hospital day unit chemotherapy treatment
Control group
Active

Outcomes
Primary outcome [1] 294204 0
Primary outcome 1: Patient experience (Patient Experience Questionnaire)
Timepoint [1] 294204 0
Timepoint Primary Outcome 1 - Patient experience: after fourth treatment cycle
Primary outcome [2] 294260 0
Primary Outcome 2: Quality of Life (Functional Assessment of Chronic Illness Therapy Questionnaire FACT-G version 4)
Timepoint [2] 294260 0
Timepoint Primary Outcome 2 - Quality of Life: Baseline and after fourth treatment cycle
Secondary outcome [1] 312786 0
Secondary outcome 1: Anxiety and depression - (Hospital Anxiety and Depression Scale [HADS])
Timepoint [1] 312786 0
Secondary timepoint 1: baseline and after cycle 4
Secondary outcome [2] 312892 0
Secondary outcome 2: Nausea and vomiting - (Multinational Association of Supportive Care in Cancer [MASCC/ Antiemesis Tool)
Timepoint [2] 312892 0
Secondary timepoint 2: After cycles 3 and 4
Secondary outcome [3] 312893 0
Secondary outcome 3: Safety (Medical Records)
Timepoint [3] 312893 0
Secondary timepoint 3: Baseline and after cycle 3
Secondary outcome [4] 313036 0
Secondary outcome 4: Unplanned admissions (Medical Records)
Timepoint [4] 313036 0
Secondary timepoint 4: Baseline and after cycle 3
Secondary outcome [5] 313037 0
Secondary outcome 5: Total length of time taken to receive treatment - (Interview Tool, specifically designed for this study)
Timepoint [5] 313037 0
Secondary timepoint 5: Baseline and after cycle 3
Secondary outcome [6] 313038 0
Secondary outcome 6: Opinions on waiting times (Interview Tool, specifically designed for this study)
Timepoint [6] 313038 0
Secondary timepoint 6: Baseline and after cycle 3
Secondary outcome [7] 313039 0
Secondary outcome 7: Impact of waiting times - (Interview Tool, specifically designed for this study)
Timepoint [7] 313039 0
Secondary timepoint 7: Baseline and after cycle 3
Secondary outcome [8] 313040 0
Secondary outcome 8: Patient-related costs - (Interview Tool, specifically designed for this study)
Timepoint [8] 313040 0
Secondary timepoint 8: Baseline and after cycle 3

Eligibility
Key inclusion criteria
The inclusion criteria for study participants are: scheduled to receive chemotherapy for breast cancer and suitable for day-case administration; expect to receive at least four cycles of chemotherapy; are aged 18 years or older; WHO performance status of 0,1 or 2, and are able to provide written informed consent. Patients have received two doses of chemotherapy in the hospital-based chemotherapy unit without adverse events prior to enrolment in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who are <18 years old; Those who are unable to give informed consent for any reason; Chemotherapy regimens requiring more than 2 hours administration time; Concurrent uncontrolled medical illness likely to interfere with compliance and a serious adverse event (defined as CTCAE v4 GIII/IV adverse event) during administration of cycles 1 or 2; Patients who suffer either anaphylactic or severe hypersensitivity reaction in the first two cycles of treatment in the hospital day unit; only female patients will be recruited.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Ethics
Date of first participant enrolment
Anticipated
29/01/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3398 0
Sir Charles Gairdner Hospital - Nedlands

Funding & Sponsors
Funding source category [1] 290685 0
Government body
Name [1] 290685 0
WA Department of Health
Country [1] 290685 0
Australia
Primary sponsor type
Individual
Name
A/Prof Suzanne Robinson
Address
Curtin University
GPO BOX U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 289379 0
Individual
Name [1] 289379 0
Prof Joanna Dewar
Address [1] 289379 0
B Block, Sir Charles Gairdner Hospital
Hospital Ave
Nedlands WA 6009
Country [1] 289379 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292315 0
Sir Charles Gardner Group Human Research Ethics Committee
Ethics committee address [1] 292315 0
Human Research Ethics Committee
2nd Floor, A Block
Sir Charles Gairdner Hospital
Hospital Ave
NEDLANDS WA 6009
Ethics committee country [1] 292315 0
Australia
Date submitted for ethics approval [1] 292315 0
18/11/2014
Approval date [1] 292315 0
11/02/2015
Ethics approval number [1] 292315 0
EC00271

Summary
Brief summary
The study is assessing the costs and patient related outcomes associated with chemotherapy delivered at home versus chemotherapy delivered in the hospital setting for breast cancer patients.

Who is it for?
You may be eligible to join this study if you are a female aged 18 years or above who is scheduled to receive at least four cycles of chemotherapy for breast cancer and are suitable for day-case administration.

Study details
All participants in this study will receive their first two cycles of chemotherapy in a hospital day unit as per standard care. Provided that the participants do not experience any severe adverse events, they will then be randomly (by chance) allocated to receive their next two chemotherapy cycles either in the hospital day unit or in their home setting. In the home setting, chemotherapy will be administered intravenously by a trained nurse. Your chemotherapy treatment regime will not change.

All participants will be asked to complete a number of questionnaires before, during and after chemotherapy treatment in order to evaluate their patient experience, quality of life, anxiety and depression, nausea and vomiting, and treatment safety. Treatment-related costs will also be analysed. It is thought that treatment at home may provide not only a better patient experience, but may deliver a more sustainable health service model of care for the WA Health Department.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54622 0
A/Prof Suzanne Robinson
Address 54622 0
Curtin University
GPO BOX U1987
Perth, WA, 6845
Country 54622 0
Australia
Phone 54622 0
+61 8 9266 4921
Fax 54622 0
Email 54622 0
[email protected]
Contact person for public queries
Name 54623 0
Suzanne Robinson
Address 54623 0
Curtin University
GPO BOX U1987
Perth, WA, 6845
Country 54623 0
Australia
Phone 54623 0
+ 61 8 9266 4921
Fax 54623 0
Email 54623 0
[email protected]
Contact person for scientific queries
Name 54624 0
Suzanne Robinson
Address 54624 0
Curtin University
GPO BOX U1987
Perth, WA, 6845
Country 54624 0
Australia
Phone 54624 0
+61 8 9266 4921
Fax 54624 0
Email 54624 0
[email protected]

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.