Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001113640
Ethics application status
Approved
Date submitted
9/10/2014
Date registered
21/10/2014
Date last updated
3/11/2021
Date data sharing statement initially provided
3/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Effect of a Shared Care Pathway Intervention on Unplanned Presentations to Hospital by Chemotherapy Outpatients
Scientific title
Evaluating the Effect of a Shared Care Pathway Intervention on Unplanned Presentations to Hospital by Chemotherapy Outpatients
Secondary ID [1] 285504 0
None
Universal Trial Number (UTN)
Trial acronym
ESCAPI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 293199 0
Chemotherapy related unplanned hospital presentations 293201 0
Chemotherapy related symptoms 293202 0
Condition category
Condition code
Cancer 293475 293475 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves a set number of community nurse (CN) contacts during the patients' first three cycles of chemotherapy (usually 21 days, but this can vary depending on chemotherapy regimen used). CNs will visit patients at home, two visits for each cycle of chemotherapy, and assess patients' general physical and psychosocial wellbeing, provide care for chemotherapy side effects and assess patients' and carers' understanding of chemotherapy regimens. Each visit will take approximately one hour to complete, but this may vary depending on patient needs. CNs will liaise with the patients' GP and cancer centre regarding patients' treatment needs.
Intervention code [1] 290385 0
Prevention
Intervention code [2] 290445 0
Treatment: Other
Comparator / control treatment
Standard care - Patients undergoing chemotherapy will receive standard/usual care and support from their oncologist and cancer centre staff. In this group the patient or carer will contact the cancer centre if they are concerned about chemotherapy related symptoms.
Control group
Active

Outcomes
Primary outcome [1] 293311 0
Unplanned hospital presentations as assessed by data linkage to medical records
Timepoint [1] 293311 0
A the end of the third cycle (week 9, but this can vary depending on chemotherapy regimen used)
Secondary outcome [1] 310778 0
Anxiety and depression assessed using HADS tool
Timepoint [1] 310778 0
Measured at baseline and end of cycles 1 to 3 (week 3, 6 and 9, but this can vary depending on chemotherapy regimen used)
Secondary outcome [2] 310779 0
The EORTC QLQ-C30 will be used to assess cancer-specific function and symptoms and global quality of life
Timepoint [2] 310779 0
Measured at baseline and end of cycles 1 to 3 (week 3, 6 and 9, but this can vary depending on chemotherapy regimen used)
Secondary outcome [3] 310780 0
The CBI-B will be used to assess self-efficacy and confidence for coping with cancer and quality of life
Timepoint [3] 310780 0
Measured at baseline and end of cycles 1 to 3 (week 3, 6 and 9, but this can vary depending on chemotherapy regimen used)
Secondary outcome [4] 310781 0
Quality of life assessed using the SF-36
Timepoint [4] 310781 0
Measured at baseline and end of cycles 1 to 3 (week 3, 6 and 9, but this can vary depending on chemotherapy regimen used)

Eligibility
Key inclusion criteria
1) Over 18 years of age;
2) Commencing their first cycle of chemotherapy as an outpatient at one of the participating cancer centres;
3) Fully aware of their cancer diagnosis;
4) Residing at one of the suburbs serviced by the community centres enrolled in the study, for the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Unable to give informed consent;
2) Receiving treatment for haematological cancers;
3) Receiving concurrent chemotherapy and radiotherapy.
4) Non English Speaking

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be achieved using opaque, sequentially numbered envelopes containing group assignment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be individually randomised to intervention or control group in random permuted blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation:

Data from our retrospective study were used to calculate the required sample size. There were 518 chemotherapy patients of whom 233 (45%) made an unplanned presentation to hospital within 6 months of receiving chemotherapy. Of the 518 patients there were 363 in the target group for this study (cycles 1, 2 & 3), of whom 132 (36.4%) made 204 unplanned presentations on cycles 1, 2 & 3. The research team estimates that the intervention will reduce this rate by 35% (response rate ratio: 0.65). Following the Poisson regression procedure within PASS, to achieve a 35% reduction in number of presentations, assessed once at the end of cycle 3, with a=0.05 (two-tailed) and beta=0.80, a total sample size of 326 is required. This represents a reduction in unplanned presentations from 91/163 (controls) to 59/163 (intervention). The sample size will be increased by 20% to 408 to allow for loss to follow-up.

Primary data analysis:
The primary analysis of the primary outcome, unplanned hospital presentations, will be unadjusted and will use a negative binomial regression model to test the effect of the intervention.

The primary analysis of all secondary outcomes will be a comparison of values at the end of cycle 3 between intervention and control groups using a 2-sample t-test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/11/2014
Actual
4/06/2015
Date of last participant enrolment
Anticipated
Actual
27/11/2018
Date of last data collection
Anticipated
Actual
12/02/2019
Sample size
Target
408
Accrual to date
Final
353
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3038 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 3039 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 8804 0
2137 - Concord
Recruitment postcode(s) [2] 8805 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 290060 0
Government body
Name [1] 290060 0
National Health and Medical Research Council
Country [1] 290060 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Cancer Nursing Research Unit
Level 6 North, Chris O'Brien Lifehouse
119-143 Missenden Road, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 288769 0
None
Name [1] 288769 0
N/A
Address [1] 288769 0
N/A
Country [1] 288769 0
Other collaborator category [1] 278178 0
Government body
Name [1] 278178 0
Sydney Local Health District, Community Health
Address [1] 278178 0
KGV building, Level 11
Missenden Road, Camperdown, NSW,2050
Country [1] 278178 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297439 0
HREC Sydney Local Health District (RPAH)
Ethics committee address [1] 297439 0
Ethics committee country [1] 297439 0
Australia
Date submitted for ethics approval [1] 297439 0
19/04/2013
Approval date [1] 297439 0
07/05/2013
Ethics approval number [1] 297439 0
Protocol No X13-0101

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

Contacts
Principal investigator
Name 51522 0
Prof Kate White
Address 51522 0
Level 6 North, Chris O'Brien Lifehouse
119-143 Missenden Road,
Camperdown NSW 2050
Country 51522 0
Australia
Phone 51522 0
+612 8627 1567
Fax 51522 0
+61 2 8627 1500
Email 51522 0
[email protected]
Contact person for public queries
Name 51523 0
Chantale Boustany
Address 51523 0
Level 6 North, Chris O'Brien Lifehouse
119-143 Missenden Road,
Camperdown NSW 2050
Country 51523 0
Australia
Phone 51523 0
+612 8627 0405
Fax 51523 0
+61 2 8627 1500
Email 51523 0
[email protected]
Contact person for scientific queries
Name 51524 0
Chantale Boustany
Address 51524 0
Level 6 North, Chris O'Brien Lifehouse
119-143 Missenden Road,
Camperdown NSW 2050
Country 51524 0
Australia
Phone 51524 0
+612 8627 0405
Fax 51524 0
+61 2 8627 1500
Email 51524 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
SourceTitleYear of PublicationDOI
EmbaseEvaluating a shared care pathway intervention for people receiving chemotherapy to reduce post-treatment unplanned hospital presentations: a randomised controlled trial.2024https://dx.doi.org/10.1007/s00520-023-08261-w
N.B. These documents automatically identified may not have been verified by the study sponsor.