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Trial registered on ANZCTR


Registration number
ACTRN12619001594112
Ethics application status
Approved
Date submitted
8/11/2019
Date registered
19/11/2019
Date last updated
19/11/2019
Date data sharing statement initially provided
19/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing a nurse-coordinated, integrated, shared-care model involving specialists and general practitioners in breast cancer post-treatment follow-up: a Phase II randomised controlled trial
Scientific title
ImplEMenting a nurse-coordinated, INtegrated, shared-care model involving specialists and general practitioners in breast cancer post-treatmENT follow-up: a Phase II randomised controlled trial (The EMINENT Trial)
Secondary ID [1] 299738 0
Nil known
Universal Trial Number (UTN)
U1111-1243-1620
Trial acronym
EMINENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 315088 0
Condition category
Condition code
Cancer 313423 313423 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At completion of treatment [i.e., end of surgery, or adjuvant chemotherapy/ radiation therapy (whichever was delivered last)], patients will be enrolled in the study.

Group 1 (The shared-care group):
1 x 20 minute Cancer Pharmacy consultation for medication reconciliation and education prior to specialist nurse consult (only patients who completed chemotherapy, radiotherapy or those who will receive aromatase inhibitor).
1 x 30-60 minute Specialist Nurse consult with patient 8+/-2 weeks post-treatment to: 1) provide survivorship patient education; 2) treatment summary; 3) co-develop a Survivorship Care Plan (SCP) including SMART goals (using motivational interviewing and self-efficacy techniques); and 4) follow-up appointment schedule. A completed draft treatment summary and SCP will be provided to the patient and the GP.
1 x 20-30 minute case-conference between specialist nurse and GP within 4 weeks of nurse consultation to discuss intervention follow-up schedule, the draft SCP with the GP and negotiate GP role in facilitating SCP goals.
11 x alternating 6-monthly patient appointments with cancer specialist or GP for 5 years. At 5 years the patient will be discharged to the care of the GP. More specifically,
5 x GP appointments at <12 (initial), 18, 30, 42 and 54 months post-diagnosis for review of SCP, general health, and screening/management of comorbidities, psychosocial health cancer treatment toxicities, cancer-related symptoms; chronic disease management planning and allied health referrals. The GP will have direct telephone access to the specialist nurse in case of concerns or escalation for acute care review.
6 x cancer specialist appointments at 12, 18, 24, 36, 48 and 60 months post-diagnosis for review, physical examination and imaging (i.e., annual mammogram) at 12, 18, 24, 36, 48 and 60 months post-diagnosis.
- A log of all consultations will be kept by treating nurse
Intervention code [1] 316003 0
Behaviour
Intervention code [2] 316005 0
Treatment: Other
Comparator / control treatment
Group 2 (Information only):
Standard follow-up care plus a written survivorship booklet on “Living Well After Cancer” published by Cancer Council Australia. The current follow-up arrangement is a specialist-led model as determined by the treating surgeons, medical oncologist, and radiation oncologist.
Control group
Active

Outcomes
Primary outcome [1] 321906 0
Health Related Quality of Life as measured by the the Functional assessment of Cancer therapy-breast (FACT-B), which consists of a general questionnaire (27-item FACT-G) and also a 15-item breast-specific subscale.
Timepoint [1] 321906 0
Measured at baseline, 3 months, 6 months, 12 months
Secondary outcome [1] 376640 0
Physical activity as measured by questions from the Active Australia Survey (Australian Institute of Health and Welfare, 2003)
Timepoint [1] 376640 0
Measured at baseline, 3 months, 6 months and 12 months
Secondary outcome [2] 376641 0
Patient experience as measured by the Picker experience questionnaire 15 (PPE15)
Timepoint [2] 376641 0
Measured at baseline, 3 months, 6 months and 12 months
Secondary outcome [3] 376642 0
Financial toxicity as measured by the 11-item COmprehensive Score for financial Toxicity (COST)-Functional Assessment of Chronic Illness Therapy (FACIT) tool.
Timepoint [3] 376642 0
Measured at baseline, 3 months, 6 months and 12 months.
Secondary outcome [4] 376643 0
Adherence to annual mammography, annual physical examination, & endocrine therapy as measured by Hospital records
Timepoint [4] 376643 0
For this pilot trial, the first annual adherence checks will be covered within the timeframe
Secondary outcome [5] 376644 0
Emergency presentation; hospitalisation as measured by patient self-report and verified with hospital records.
Timepoint [5] 376644 0
Measured retrospectively from 3 to 12 months
Secondary outcome [6] 376645 0
Satisfaction of care as measured by a 0-10 numerical analogue scale with 10 being the most satisfied; supplemented with short, structured qualitative questions.
Timepoint [6] 376645 0
Measured at 12 months post-baseline.
Secondary outcome [7] 376646 0
Process Outcomes (for Intervention group ; Arm 1 only)
- Completed nurse-led consultation (Y/N) as per nurse record in research database
- Completed case conferencing (Y/N) as per nurse record in research database
- Completed survivorship care plan/components (Y/N) as per nurse record in research database
- Length of clinical encounters at the cancer centre as per nurse record in research database
- Completed Chronic Disease Management plan (Y/N) as per Medicare Benefit Schedule record
- Number of access of rapid referral back to acute care as per nurse record in research database , verified with hospital record
- Number and timing of GP visits and specialist visits as per Medicare Benefit Schedule record
Timepoint [7] 376646 0
Measured retrospectively from baseline to 12 months.
Secondary outcome [8] 376647 0
Health resource utilisation will assess both health service use and participant out-of-pocket costs as measured by including administrative data sets Medicare Benefits Schedule, Pharmaceutical Benefits Scheme and iPharmacy records. These data will inform participants’ utilisation of services that qualify under the MBS as well as medications dispensed under the PBS.
Timepoint [8] 376647 0
Collected at 3 , 6 and 12 months
Secondary outcome [9] 376702 0
5 dimensions of health status (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) as measured by the EQ-5D-5L.
Timepoint [9] 376702 0
Baseline, 3, 6, 12 months
Secondary outcome [10] 376854 0
Dietary behaviour as measured by questions from the Short dietary questions (Rutishauser, Webb, Abraham, & Allsopp, 2001)
Timepoint [10] 376854 0
Measured at baseline, 3 months, 6 months and 12 months.
Secondary outcome [11] 376855 0
Sedentary behaviour as measured by questions from the International Physical Activity Questionnaire(Craig et al., 2003)
Timepoint [11] 376855 0
Measured at baseline, 3 months, 6 months and 12 months.

Eligibility
Key inclusion criteria
Patients who
- are treated at the Princess Alexandra Hospital
- are within two weeks of completion of adjuvant treatment for early stage breast cancer patients (including Ductal Carcinoma In-Situ (DCIS) and locally advanced breast cancer)l; OR within 4 weeks post-surgery if they are not scheduled for any further adjuvant therapy;
- have received a diagnosis of curable early breast cancer (i.e. no distant metastases);
- are able to speak and read English;
- are at least 18 years of age;
- are ambulatory patient at the time of recruitment;
- have an Eastern Cooperative Oncology Group performance status 0 or 1;
- are able to nominate a GP to be involved in their follow-up; and
- have access to a telephone.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- the presence of severe mental, cognitive or physical conditions that would limit the patient’s ability to participate.
- breast cancer recurrence
- presence of distant metastases

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation code will be kept in a sealed opaque envelope. Allocation will remain concealed from the research nurse and patient until after the patient is consented.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Four permuted block (blocks of 4 and 8) randomisation sequences will be used to allocate treatment arms in a 1:1 ratio. Randomisation by treatment characteristic (i.e., surgery only, surgery + radiation, surgery + radiation + chemotherapy, surgery + radiation + chemotherapy + herceptin) will ensure ensure even allocation to each treatment arm for each treatment subgroup.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to report on feasibility and process-related elements (e.g., recruitment, intervention, retention rates) as well as clinical and resource outcomes. Preliminary effect size estimates for patient and resource use outcomes will be calculated following intention-to-treat principles using generalised linear mixed models. In addition to reporting trial findings, stochastic (probabilistic) modelling will be used to conduct trial-simulation studies based on trial patient and cost outcome distributions and correlation matrices for repeated measures to determine sample size requirements for a large definitive trial that has power to measure both clinical effectiveness, and cost-effectiveness (based data from this trial).

Recruitment
Recruitment status
Not yet 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)
QLD
Recruitment hospital [1] 15121 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 28415 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 304213 0
Hospital
Name [1] 304213 0
Metro South Health SERTA grant
Address [1] 304213 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country [1] 304213 0
Australia
Primary sponsor type
Individual
Name
Professor Raymond Chan
Address
Division of Cancer Services
Level 2
199 Ipswich Road
Princess Alexandra Hospital
Woolloongabba
QLD 4102

School of Nursing
N Block Level 3 342
Victoria Park Road
Queensland University of Technology
Kelvin Grove
QLD 4059
Country
Australia
Secondary sponsor category [1] 304451 0
None
Name [1] 304451 0
Address [1] 304451 0
Country [1] 304451 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304675 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 304675 0
Metro South Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 304675 0
Australia
Date submitted for ethics approval [1] 304675 0
08/03/2019
Approval date [1] 304675 0
01/05/2019
Ethics approval number [1] 304675 0
HREC/2019/QMS/51956

Summary
Brief summary
The purpose of this study is to test the feasibility of a care model involving specialists and GPs for early breast cancer post-treatment follow-up.

Who is it for?
You may be eligible for this study if you are aged 18 or older, and have recently completed treatment for breast cancer.

Study details
Participants in this study will be randomised by chance (like flipping a coin) into two groups. One group will receive standard follow-up (specialist lead) care and information from Cancer Council Australia. The other group will undergo the share-care model. This involves a series of 20 to 60 minute appointments with specialist nurses, GPs and cancer specialists for up to 5 years.
As part of the study all participants will answer a series of questionnaires every 3 months for 12 months.

It is hoped this research will demonstrate the feasibility and usefulness of the new model of care which could influence future post-treatment cancer care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97818 0
Prof Raymond Chan
Address 97818 0
Division of Cancer Services
Level 2
199 Ipswich Road
Princess Alexandra Hospital
Woolloongabba
QLD 4102

School of Nursing
N Block Level 3 342
Victoria Park Road
Queensland University of Technology
Kelvin Grove
QLD 4059
Country 97818 0
Australia
Phone 97818 0
+61 7 31387311
Fax 97818 0
Email 97818 0
Raymond.chan@qut.edu.au
Contact person for public queries
Name 97819 0
Prof Raymond Chan
Address 97819 0
Division of Cancer Services
Level 2
199 Ipswich Road
Princess Alexandra Hospital
Woolloongabba
QLD 4102

School of Nursing
N Block Level 3 342
Victoria Park Road
Queensland University of Technology
Kelvin Grove
QLD 4059
Country 97819 0
Australia
Phone 97819 0
+61 7 31387311
Fax 97819 0
Email 97819 0
Raymond.chan@qut.edu.au
Contact person for scientific queries
Name 97820 0
Prof Raymond Chan
Address 97820 0
Division of Cancer Services
Level 2
199 Ipswich Road
Princess Alexandra Hospital
Woolloongabba
QLD 4102

School of Nursing
N Block Level 3 342
Victoria Park Road
Queensland University of Technology
Kelvin Grove
QLD 4059
Country 97820 0
Australia
Phone 97820 0
+61 7 31387311
Fax 97820 0
Email 97820 0
Raymond.chan@qut.edu.au

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 other documents available
Summary results
No Results