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Trial registered on ANZCTR


Registration number
ACTRN12618001985279
Ethics application status
Approved
Date submitted
21/11/2018
Date registered
11/12/2018
Date last updated
11/12/2018
Date data sharing statement initially provided
11/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating a multidimensional support program to support breast cancer survivors' transition back to suitable work
Scientific title
Testing the feasibility of a support intervention for transitioning back to ‘good’ work tailored to breast cancer survivors
Secondary ID [1] 296578 0
IIRS-18-071
Universal Trial Number (UTN)
U1111-1223-8067
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer survivors 310378 0
Condition category
Condition code
Cancer 309099 309099 0 0
Breast
Physical Medicine / Rehabilitation 309100 309100 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
RTW Support intervention
The intervention will provide a biopsychosocial (BPS) assessment followed by individually-tailored return to work (RTW) support. Tailored services include health coaching (enabling breast cancer survivors to successfully manage their transition to good work and living well), liaison with clinicians and employers, and individualised RTW planning and monitoring.
The intervention is to be delivered face-to-face and individually by a trained occupational rehabilitation (OR) consultant, with some follow-ups by telephone and assessments online. The duration, intensity and dose will vary, as part of the tailored / personalised nature of the intervention.
The tailoring or the personalisation of the intervention content is a unique feature and potential strength of the intervention. The tailoring will be determined by a combination of the BPS assessment results (assessment delivered during the first session with the OR consultant), and the discussion of those results with the breast cancer survivor. The consultant is trained to use the initial assessment results and associated discussions with the breast cancer survivor to determine the tailoring of the intervention content; consultant guidelines also exist to assist with this decision-making, and senior consultants with experience delivering the intervention during the pilot phase will be made available as ‘champions’ or mentors to provide advice as required.
Based on the pilot study, delivery of the entire multimodal program is expected to take a minumum of 12 weeks and a maximum of 28 weeks. For those undertaking the health coaching component, a series of weekly (up to 8) health coaching sessions will take place during this period. Each health coaching session typically takes around 60 minutes, and the BPS assessment an additional 15 minutes when required (i.e. typically the initial and final health coaching session). The health coaching and RTW services delivered face-to-face will be delivered from IPAR Rehabilitation offices in a variety of locations across Australia.
The delivery of the program by specially trained OR consultants is another unique aspect of the program, which is also being evaluated. OR consultants will all receive specialised breast cancer survivor training, delivered by a representative of Cancer Council NSW, and featuring a presentation from a breast cancer survivor speaking about her experiences transitioning back to the workplace.
Liaison with clinicians and employers is usual care, everyday practice for OR consultants. Over and above this, however, is another unique component of this intervention. Part of the service offering will also include, where relevant to the breast cancer survivor employee, support and education for their employer to facilitate the return to a supportive work environment. This is only relevant for breast cancer survivors returning to their pre-diagnosis employer after having medical leave.
Individualised RTW planning and monitoring is again usual care, everyday practice for OR consultants. For this intervention, the additional breast cancer-specific training undertaken by all consultants means that particular care will be taken to ensure that the RTW planning takes into consideration the unique needs and requirements of breast cancer survivors during their rehabilitation.
The components of the tailored multimodal intervention, as outlined above, are delivered in a flexible fashion across the 12-28 week period. The health and well-being of the breast cancer survivor involved, and their needs and circumstances following initiation of the intervention determines the overall duration. At the end of each month, as per usual care practice, each consultant will record in the Case Manager software, the intervention component status as either: not yet recommended; recommended but not yet initiated; partially completed; fully completed. Initiation and completion dates are also recorded, and for the Health Coaching, the specific modules completed are also recorded.
Intervention code [1] 312889 0
Rehabilitation
Intervention code [2] 312890 0
Treatment: Other
Intervention code [3] 312891 0
Behaviour
Comparator / control treatment
Primary outcome measures (only) will be compared with an historical control group of cancer survivors (not specific to breast cancer) individuals receiving usual care occupational rehabilitation. The data will be retrospectively collected from the IPAR case management database from the period Jan 2015 to end Dec, 2017
Control group
Historical

Outcomes
Primary outcome [1] 308071 0
Return to work (RTW) status: Categorically defined as ‘Improved work status (hours/duties)’ relative to referral; Same work status (hours/duties) relative to referral; Reduced work status (hours/duties) relative to referral. Self report.
Timepoint [1] 308071 0
Baseline, 6 months post-intervention
Primary outcome [2] 308072 0
Perceived support at work (Cancer empowerment questionnaire score)
Timepoint [2] 308072 0
Baseline, 6 months post-intervention
Primary outcome [3] 308295 0
Work capacity: Categorically defined as ‘Improved work capacity’ relative to referral; Same work capacity relative to referral; Reduced work capacity relative to referral. Determined by a standardised set of questions delivered by the OR consultant.
Timepoint [3] 308295 0
Baseline, 6 months
Secondary outcome [1] 353872 0
Change in Quality of life (change in QLQ-30 score)
Timepoint [1] 353872 0
Baseline, Immediately post-intervention, 6 months post-intervention
Secondary outcome [2] 353873 0
Recovery Expectations, single item (as yet unvalidated, but closely based on single item from Dionne et al., 2005, CMAJ). Component of study-specific tool, called Positivum: Cancer Assessment
Timepoint [2] 353873 0
Baseline, Immediately post-intervention, 6 months post-intervention
Secondary outcome [3] 353874 0
Change in Psychological distress (change in K-6 score)
Timepoint [3] 353874 0
Baseline, Immediately post-intervention, 6 months post-intervention
Secondary outcome [4] 353875 0
Physical fatigue (energy levels): Validated subscale from Bidimensional Fatigue Scale
Timepoint [4] 353875 0
Baseline, Immediately post-intervention, 6 months post-intervention
Secondary outcome [5] 353876 0
Change in empowerment / resilience (Change in items on Cancer Empowerment Questionnaire)
Timepoint [5] 353876 0
Baseline, Immediately post-intervention, 6 months post-intervention
Secondary outcome [6] 353877 0
Pain severity and interference: Two validated items from the QLQ-30
Timepoint [6] 353877 0
Baseline, Immediately post-intervention, 6 months post-intervention
Secondary outcome [7] 353878 0
Perceived effectiveness (quantitative HeiQ scores; qualitative results from focus groups). Two focus groups are planned with 8-10 participants, audio-recorded, moderated by researcher. Approx duration 30-45 minutes.
Timepoint [7] 353878 0
Immediately post-intervention
Secondary outcome [8] 353879 0
Acceptability (perceptions, experiences, opinions) - from qualitative focus group results. Two focus groups are planned with 8-10 participants, audio-recorded, moderated by researcher. Approx duration 30-45 minutes.
Timepoint [8] 353879 0
Immediately post-intervention
Secondary outcome [9] 353880 0
Change in fear of recurrence (change in CARQ-4 score)
Timepoint [9] 353880 0
Baseline, Immediately post-intervention, 6 months post-intervention
Secondary outcome [10] 354562 0
Health Beliefs - multi-item, as yet unvalidated. Component of study-specific tool, called Positivum: Cancer Assessment
Timepoint [10] 354562 0
Baseline, Immediately post-intervention, 6 months post-intervention
Secondary outcome [11] 354563 0
Work Beliefs - multi-item (as yet unvalidated). Component of study-specific tool, called Positivum: Cancer Assessment
Timepoint [11] 354563 0
Baseline, Immediately post-intervention, 6 months post-intervention
Secondary outcome [12] 354564 0
Employer perceptions - multi-item (as yet unvalidated). Component of study-specific tool, called Positivum: Cancer Assessment
Timepoint [12] 354564 0
Baseline, Immediately post-intervention, 6 months post-intervention
Secondary outcome [13] 354565 0
Cognitive fatigue (memory & concentration): Validated subscale from Bidimensional Fatigue Scale
Timepoint [13] 354565 0
Baseline, Immediately post-intervention, 6 months post-intervention

Eligibility
Key inclusion criteria
Breast cancer survivors unable to work in their regular (pre-diagnosis) capacity for at least 3 months due to breast cancer. Potential participants should not yet have returned to work at full capacity and need to have been working prior to diagnosis and treatment for their breast cancer.
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Those to be excluded include those:
- NOT requiring support to facilitate a transition back to work (self-report)
- whose breast cancer is a recurrence (as opposed to first incidence)
- whose treatment was completed longer than 6 months ago
- whose health and other circumstances indicate a lack of readiness to participate in the intervention

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation procedure used
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
As this is a feasibility study, we are using an evaluation framework to assess acceptability and implementation, and PRELIMINARY indications of effectiveness. A single cohort prospective, follow-up design is to be used.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This feasibililty trial will provide the preliminary outcome data needed in order to determine the number of participants for the next stage randomised controlled trial. Approximate numbers were based on similar published feasibility stage trials.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/01/2019
Actual
Date of last participant enrolment
Anticipated
8/11/2019
Actual
Date of last data collection
Anticipated
31/08/2020
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 301157 0
Charities/Societies/Foundations
Name [1] 301157 0
National Breast Cancer Foundation
Country [1] 301157 0
Australia
Primary sponsor type
Individual
Name
Dianne Sheppard
Address
Monash University Accident Research Centre
Building 70, 21 Alliance Lane
Monash University
Clayton, VIC
3800
Country
Australia
Secondary sponsor category [1] 300775 0
Individual
Name [1] 300775 0
Georgia Halkett
Address [1] 300775 0
School of Nursing, Midwifery and Paramedicine
Curtin University
Kent Street,
Bentley
WA 6102
Country [1] 300775 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301903 0
Monash University Human Research and Ethics Committee (MUHREC)
Ethics committee address [1] 301903 0
Ethics committee country [1] 301903 0
Australia
Date submitted for ethics approval [1] 301903 0
20/04/2018
Approval date [1] 301903 0
01/06/2018
Ethics approval number [1] 301903 0
13300

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

Contacts
Principal investigator
Name 88498 0
A/Prof Georgia Halkett
Address 88498 0
School of Nursing, Midwifery and Paramedicine
Curtin University
Kent Street,
Bentley
WA 6102
Country 88498 0
Australia
Phone 88498 0
+61 8 9266 1762
Fax 88498 0
Email 88498 0
g.halkett@curtin.edu.au
Contact person for public queries
Name 88499 0
Dianne Sheppard
Address 88499 0
Monash University Accident Research Centre
Building 70, 21 Alliance Lane,
Monash University
Clayton
VIC 3800
Country 88499 0
Australia
Phone 88499 0
+61 3 99051860
Fax 88499 0
Email 88499 0
dianne.sheppard@monash.edu
Contact person for scientific queries
Name 88500 0
Dianne Sheppard
Address 88500 0
Monash University Accident Research Centre
Building 70, 21 Alliance Lane,
Monash University
Clayton
VIC 3800
Country 88500 0
Australia
Phone 88500 0
+61 3 99051860
Fax 88500 0
Email 88500 0
dianne.sheppard@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
De-identified data will be available upon request and at the discretion of the research team, however, limited feasibility trial funding precludes the development of data dictionaries


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
Embase'Beyond Cancer': a study protocol of a multimodal occupational rehabilitation programme to support breast cancer survivors to return work.2019https://dx.doi.org/10.1136/bmjopen-2019-032505
EmbaseBuilding a novel occupational rehabilitation program to support cancer survivors to return to health, wellness, and work in Australia.2020https://dx.doi.org/10.1007/s11764-019-00824-3
N.B. These documents automatically identified may not have been verified by the study sponsor.