Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000188831
Ethics application status
Approved
Date submitted
14/12/2020
Date registered
22/02/2021
Date last updated
22/09/2024
Date data sharing statement initially provided
22/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of a nurse-enabled, shared-care follow-up model for early breast cancer survivors (The IBIS-Survivorship Study)
Scientific title
Implementation and evaluation of a nurse-enabled, shared-care follow-up model for early breast cancer survivors on health-related quality of life (The IBIS-Survivorship Study)
Secondary ID [1] 302941 0
None
Universal Trial Number (UTN)
U1111-1262-2498
Trial acronym
IBIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 319970 0
Condition category
Condition code
Cancer 317903 317903 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Six sites across Australia will gain access to IBIS-Survivorship model of care to be rolled out every 4 months.

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. If the site has been randomised to commence the intervention then participants will receive the IBIS-Survivorship model of care:

1 x 30-60 minute face-to-face or telehealth Specialist Cancer Nurse consult with the participant 8+/-2 weeks post-treatment to: 1) provide treatment summary; 2) provide survivorship patient education including a written survivorship booklet on “Living Well After Cancer” published by Cancer Council Australia; 3) co-develop a draft Survivorship Care Plan (SCP) including SMART goals (using motivational interviewing and self-efficacy techniques); and 4) provide a draft post-treatment shared-care follow-up appointment schedule. A draft SCP (including the treatment summary) will be provided to the participant via email or post and their nominated GP via GP clinic preferred communication system. Adherence to the nurse-led clinic and it's components will be monitored using a nurse-led clinic checklist.

1 x 20-30 minute video/telephone case-conference between the Specialist Cancer Nurse and GP (+/- GP practice nurse) within 4 weeks of Specialist Cancer Nurse consult to finalise the SCP and negotiate the GP’s role in facilitating SCP SMART goals as well as seek agreement on the post-treatment shared-care follow-up appointment schedule. Adherence to the GP case conference and it's components will be monitored using a GP case conference checklist.

Up to 11 (depending on how far post-diagnosis the patient is when they enter the study) alternating 6-monthly face to face or telehealth (as per clinician) 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, screening/management of comorbidities, psychosocial health cancer treatment toxicities, cancer-related symptoms, chronic disease management planning, allied health referrals and physical examinations (if required/agreed). The GP appointments duration will vary depending on participant need. Additional appointments with the GP can be scheduled if clinically indicated. The GP will have direct telephone access to the Specialist Cancer Nurse in case of concerns or escalation for acute care review. Adherence to the minimum GP appointment schedule will be monitored using MBS data.

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). The cancer specialist appointments duration will vary depending on participant need. Additional appointments with the cancer specialists can be scheduled if clinically indicated. Adherence to the minimum specialist appointment schedule will be monitored by checking medical records and hospital appointment scheduling data.
Intervention code [1] 319228 0
Behaviour
Comparator / control treatment
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. If the site has not yet been randomised to commence the intervention, then participants will receive 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. Follow-up care will be offered up to 5 years post-diagnosis.
Control group
Active

Outcomes
Primary outcome [1] 325954 0
Health-related quality of life as assessed by the composite Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) questionnaire score
Timepoint [1] 325954 0
Baseline, 6 months post-baseline, 12 months post-baseline (primary timepoint)
Secondary outcome [1] 389659 0
Patient experience of care as assessed by the composite Patient Assessment of Care for Chronic Conditions (PACIC) questionnaire
Timepoint [1] 389659 0
6 months post-baseline, 12 months post-baseline
Secondary outcome [2] 389663 0
Comorbidity burden as assessed using the composite Self-Administered Comorbidity Questionnaire with additional items from the Charleston Comorbidity Index and comorbidity list.
Timepoint [2] 389663 0
Baseline, 12 months post-baseline
Secondary outcome [3] 389666 0
Average weekday sitting time as measured in hours by a single item from the International Physical Activity Questionnaire short-form (IPAQ-S) questionnaire.
Timepoint [3] 389666 0
Baseline, 6 months post-baseline and 12 months post-baseline,
Secondary outcome [4] 389669 0
Usual fruit and vegetable intake as measured by two short dietary questions from the National Nutrition Survey questionnaire.
Timepoint [4] 389669 0
Baseline, 6 months post-baseline and 12 months post-baseline,
Secondary outcome [5] 389670 0
Financial Toxicity as measured by the composite Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST-FACIT) questionnaire.
Timepoint [5] 389670 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [6] 389673 0
Unplanned hospital admissions as reported by patient self-report (Y/N) and verified with hospital medical records.
Timepoint [6] 389673 0
6 months and 12 months post-baseline
Secondary outcome [7] 389674 0
Satisfaction of care as measured by 0-10 numerical analogue scale (with 10 being the most satisfied and 0 being least satisfied).
Timepoint [7] 389674 0
12 months post-baseline
Secondary outcome [8] 389675 0
% model of care uptake among eligible patients as recorded by research screening and recruitment logs
Timepoint [8] 389675 0
End of study
Secondary outcome [9] 389676 0
% eligible patients offered the IBIS-Survivorship as recorded by research screening and recruitment logs
Timepoint [9] 389676 0
End of study
Secondary outcome [10] 389677 0
% GPs agreeing to participate in shared-care arrangement as measured by completion (Y/N) of the GP Case Conference checklist designed specifically for the study.
Timepoint [10] 389677 0
End of study
Secondary outcome [11] 389678 0
Completion (Y/N) and duration (min) of the specialist cancer nurse-led survivorship clinic as measured by Clinic checklist designed specifically for the study
Timepoint [11] 389678 0
6-10 weeks post-baseline (survivorship clinic)
Secondary outcome [12] 389679 0
Completion (Y/N) and duration (minutes) of Case Conferencing with GP as measured by GP Case Conference checklist designed specifically for the study
Timepoint [12] 389679 0
Within 4 weeks after survivorship clinic (GP case-conference)
Secondary outcome [13] 389680 0
Completed survivorship care plan/components (Y/N) as measured by survivorship care plan developed specifically for this study
Timepoint [13] 389680 0
Retrospectively from GP case conference to end of study
Secondary outcome [14] 389681 0
Number of access of rapid referral back to acute care as measured by research records and verified with medical records
Timepoint [14] 389681 0
Retrospectively at 5 years (to study enrollment).
Secondary outcome [15] 389682 0
GP completion of chronic disease management plan (Y/N) as measured by Medicare Benefits Schedule (MBS) records
Timepoint [15] 389682 0
Retrospectively at 5 years (to study enrollment).
Secondary outcome [16] 389683 0
Number of GP and specialist visits as measured by MBS and patient self-report (as verified by medical records)
Timepoint [16] 389683 0
Retrospectively at 5 years (to study enrollment).
Secondary outcome [17] 389684 0
Health provider satisfaction as measured by structured interview
Timepoint [17] 389684 0
12 months post-study completion.
Secondary outcome [18] 389685 0
Cost-effectiveness as measured by EQ-5D-5L questionnaire
Timepoint [18] 389685 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [19] 390966 0
Symptom burden as measured by the composite Memorial Symptom Assessment Scale (MSAS) Total score.
Timepoint [19] 390966 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [20] 390967 0
Distress from symptoms as measured by the composite Memorial Symptom Assessment Scale Global Distress Index (MSAS-GDI)
Timepoint [20] 390967 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [21] 390968 0
Average frequency, severity and distress associated with physical symptoms as measured by the composite Memorial Symptom Assessment Scale physical symptom subscale score (MSAS-PHYS)
Timepoint [21] 390968 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [22] 390969 0
Average frequency, severity and distress associated with psychological symptoms as measured by the composite Memorial Symptom Assessment Scale psychological symptom subscale score (MSAS-PSYCH)
Timepoint [22] 390969 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [23] 390970 0
Cancer-related fatigue as measured by composite Brief Fatigue Inventory (BFI) questionnaire global fatigue score.
Timepoint [23] 390970 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [24] 390971 0
Incidence of fatigue as measured by a single item (Y/N) on the Brief Fatigue Inventory (BFI) questionnaire.
Timepoint [24] 390971 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [25] 390972 0
Severity of fatigue as measured by composite Brief Fatigue Inventory (BFI) questionnaire fatigue severity score.
Timepoint [25] 390972 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [26] 390973 0
Fatigue interference as measured by composite Brief Fatigue Inventory (BFI) questionnaire fatigue interference score.
Timepoint [26] 390973 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [27] 390974 0
Total physical activity as measured in minutes by the Active Australia Survey (AAS) questionnaire.
Timepoint [27] 390974 0
Baseline, 6 months post-baseline and 12 months post-baseline.
Secondary outcome [28] 390975 0
Total moderate physical activity as measured in minutes by the Active Australia Survey (AAS) questionnaire.
Timepoint [28] 390975 0
Baseline, 6 months post-baseline and 12 months post-baseline.
Secondary outcome [29] 390976 0
Total vigorous physical activity as measured in minutes by the Active Australia Survey (AAS) questionnaire.
Timepoint [29] 390976 0
Baseline, 6 months post-baseline and 12 months post-baseline.
Secondary outcome [30] 390977 0
Adherence (Y/N) with annual mammography recorded from electronic medical records.
Timepoint [30] 390977 0
Annually until 5-years post-diagnosis.
Secondary outcome [31] 390978 0
Adherence with prescribed endocrine therapy as recorded from medical records.
Timepoint [31] 390978 0
Annually until 5-years post-diagnosis.
Secondary outcome [32] 392149 0
Adherence (Y/N) with annual physical examination recorded from electronic medical records.
Timepoint [32] 392149 0
Annually until 5-years post-diagnosis.

Eligibility
Key inclusion criteria
- Early breast cancer as defined as stage I-III (inclusive of ductal carcinoma in situ (DCIS) and locally advanced breast cancer but no distant metastases) who are:
- within ten weeks of completion of adjuvant treatment for early stage breast cancer at a participating site; OR within ten weeks post-surgery if not scheduled for further adjuvant therapy;
- Can identify a regular GP;
- Ambulatory with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; and
- Able to read and understand English.

Recurrent or secondary primary breast cancer, comorbidities, other prior cancer diagnoses or Trastuzumab (or biosimilars), neoadjuvant and/or ongoing endocrine therapies are NOT exclusion criteria
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- have metastatic (distant) breast cancer; or
- the presence of severe mental, cognitive or physical conditions that would limit the patient’s ability to participate at the discretion of treating clinicians

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence was produced by independent biostatisticians from University of Birmingham through an automated computer program accounting for geographical (metropolitan versus regional) covariate at the cluster level.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
This study is a multi-centre, prospective, pragmatic, stepped-wedge cluster-RCT design. The trial design involves the sequential rollout of IBIS-Survivorship to each of the clusters (in this case, cancer centres) in a randomly allocated order within the study period, with clusters progressively “crossing over” eveyr 3 months from the control group (usual care: specialist-led model) to the intervention group (receiving IBIS-Survivorship). The sites are blinded to the randomisation order until 2 months prior to the site rolling over to IBIS-Survivorship.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Generalised linear mixed models with fixed categorical effects for time; random cluster and random cluster by time effects will be used to test the difference between groups for FACT-B scores at 12 months (H1). Random cluster by time interactions will be included to allow for correlations within clusters to decay with increasing separation between times of measurement of observations. Similar analyses will be conducted for secondary outcomes (H2), applicable to the data type. Results will be presented as means or odds ratios with 95% confidence intervals. Analysis will be conducted as intention to treat and sites will be considered exposed to the intervention post-randomised cross-over date. We will also monitor the characteristics (i.e. cancer stage, hormone receptor status, age, presence of other chronic conditions, highest educational qualification, and Socio-Economic Indexes for Areas) of patients recruited both pre- and post-crossover and adjust for any differences at the analysis stage.

Economic Appraisal: We will extend methods of a standard cost-effectiveness analysis, which compare the costs and patient wellbeing associated with the intervention versus usual care, by incorporating a societal perspective. This is important in order to capture the higher complexity involved in shared-care models. Intermediate outcomes (e.g., uptake, satisfaction) will be incorporated and interactions between Specialist Cancer Nurses, GPs and patients modelled. We will assess budget impact analysis, cost-effectiveness and model longer-term predicted outcomes based on real-world evidence synthesis. Specialist Cancer Nurse costs to carry out and deliver the intervention (time and salary)
The economic evaluation, modelling and budget impact analysis will conform to international best practice methods. The benefits of IBIS-Survivorship will include intermediate outcomes which link to patient well-being (e.g. % GP adoption influencing cost-savings, symptom improvement leading to earlier return to work). Incremental cost per effect ratios will be generated which represent the additional cost and benefits (QALYs) of the intervention over and above that of usual care. Costs will be aggregated across the groups and means/totals generated. Analyses will consider advanced modelling techniques (dynamic models, discrete event or microsimulation cohorts) handled in TreeAge Pro 2018 software. Extensive one-way and probabilistic sensitivity analyses will be performed to address uncertainty and scenario analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/03/2021
Actual
10/05/2021
Date of last participant enrolment
Anticipated
22/09/2023
Actual
22/11/2023
Date of last data collection
Anticipated
22/09/2028
Actual
22/11/2023
Sample size
Target
1358
Accrual to date
Final
631
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD
Recruitment hospital [1] 18166 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 18167 0
Ipswich Hospital - Ipswich
Recruitment hospital [3] 18169 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [4] 18170 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [5] 18171 0
Gold Coast University Hospital - Southport
Recruitment hospital [6] 18172 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 32167 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 32168 0
4305 - Ipswich
Recruitment postcode(s) [3] 32170 0
2298 - Waratah
Recruitment postcode(s) [4] 32171 0
4575 - Birtinya
Recruitment postcode(s) [5] 32172 0
4215 - Southport
Recruitment postcode(s) [6] 32173 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 307364 0
Government body
Name [1] 307364 0
National Health and Medical Research Council (NHMRC)
Country [1] 307364 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] 308005 0
None
Name [1] 308005 0
Address [1] 308005 0
Country [1] 308005 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307451 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 307451 0
Ethics committee country [1] 307451 0
Australia
Date submitted for ethics approval [1] 307451 0
06/01/2020
Approval date [1] 307451 0
23/04/2020
Ethics approval number [1] 307451 0
HREC/2020/QMS/59892

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

Contacts
Principal investigator
Name 107278 0
Prof Raymond Chan
Address 107278 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 107278 0
Australia
Phone 107278 0
+61 7 31387311
Fax 107278 0
Email 107278 0
[email protected]
Contact person for public queries
Name 107279 0
Raymond Chan
Address 107279 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 107279 0
Australia
Phone 107279 0
+61 7 31387311
Fax 107279 0
Email 107279 0
[email protected]
Contact person for scientific queries
Name 107280 0
Raymond Chan
Address 107280 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 107280 0
Australia
Phone 107280 0
+61 7 31387311
Fax 107280 0
Email 107280 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.