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Trial registered on ANZCTR


Registration number
ACTRN12621001697875
Ethics application status
Approved
Date submitted
22/10/2021
Date registered
10/12/2021
Date last updated
12/04/2023
Date data sharing statement initially provided
10/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation study of a Clinician Intervention to Reduce Fear of Recurrence in Cancer Survivors
Scientific title
Implementation study of a Clinician Intervention to Reduce Fear of Recurrence in Cancer Survivors (CIFeR_2 Implementation Study)
Secondary ID [1] 305540 0
None
Universal Trial Number (UTN)
Trial acronym
CIFeR_2 Implementation Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fear of cancer recurrence 323932 0
Breast cancer 324498 0
Condition category
Condition code
Cancer 321444 321444 0 0
Breast
Public Health 321980 321980 0 0
Health service research
Mental Health 321981 321981 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an implementation study assessing the feasibility of a brief oncologist-lead educational/communication study to address fear of cancer recurrence (FCR) in breast cancer survivors in routine clinics. All participants (medical and radiation breast oncologists) will be given access to online CIFeR training hosted on the Thinkific platform, featuring didactic material on the prevalence, severity, clinical features and outcomes of FCR, description of the CIFeR (the Clinician Intervention to Reduce Fear of Recurrence (CIFeR) intervention) intervention and evidence supporting its efficacy captured in short videos of the study team, and videos of clinicians and patients modelling intervention delivery. The course is expected to take 30-60 minutes (1 session) to complete. After they have completed the training, they will be asked to complete a post-training measure of self-efficacy to manage FCR. They will then be asked to use CIFeR with suitable patients for the next 6 months. Oncologists will identify patients suitable for the CIFeR intervention by asking each patient as they attend for follow-up “Do you ever worry that your cancer will come back?” All patients who indicate any worry will be offered CIFeR. The CIFeR intervention can be delivered face-to-face or via a TeleHealth appointment.

The CIFeR intervention involves:
1) FCR normalisation and reassurance delivered by the clinician during the consultation 2) Provision of concrete prognostic information (if desired by the patient) 3) Take-home education sheet on red-flag recurrence symptoms 4) Brief advice on strategies to manage worry 5) Referral to psychologist if FCR is severe or the patient requests additional help.

The 5-component intervention was developed by the investigators from our systematic review of existing interventions* and results of cross-sectional surveys on FCR, FCR theoretical models and expert input (including psycho-oncologists, clinicians and consumers at the 2018 Psycho-Oncology Co-Operative Group Concept Development Workshop). The CIFeR intervention has also already been tested in a multicentre, single-arm Phase I/II study** to determine the usefulness, feasibility and efficacy of CIFeR. Results showed it to be feasible, acceptable and potentially efficacious in reducing FCR in breast cancer patients. We now seek to explore the barriers and facilitators to implementing this low-cost brief intervention within oncology practice in Australia.
Intervention adherence will be self-reported by oncologists (tick box for the first 3 patients they complete the intervention on). Completion rates for the training will be assessed through accessing Thinkific website analytics.

* Liu J, Butow P, Beith J: Systematic review of clinician interventions for managing fear of cancer recurrence in adult cancer survivors. Presented at the Medical Oncology Group of Australia Annual Scientific Meeting, 2018, Adelaide, Australia, 2018. Manuscript in preparation
** Liu J, Butow P, Bui KT, Serafimovska A, Kiely BE, Hui M, Goodwin A, McNeil C, Costa D, Beith J. CIFeR: A novel Clinician-lead Intervention to address Fear of cancer Recurrence (FCR) in breast cancer survivors. In Preparation.
Intervention code [1] 321942 0
Behaviour
Comparator / control treatment
Nil. This is a single arm implementation trial. All enrolled participating oncologists will receive the training to implement with their patients.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329230 0
Adoption (percentage of participating oncologists who report offering the CIFeR intervention to at least one early stage/curable breast cancer patient attending a follow-up appointment). This will be assessed as a self-reported item at the 3-month follow-up survey by the oncologist.
Timepoint [1] 329230 0
3 months after receiving the CIFeR training.
Secondary outcome [1] 401830 0
Acceptability (percentage of participating oncologists who report CIFeR to be acceptable or very acceptable), as assessed on a 4-point Likert Scale.
Timepoint [1] 401830 0
3 and 6 months after receiving the CIFeR training.
Secondary outcome [2] 401831 0
Appropriateness (percentage of participating oncologists who report CIFeR to be appropriate or very appropriate to their patients), as assessed on a 4-point Likert Scale.
Timepoint [2] 401831 0
3 and 6 months after receiving the CIFeR training.
Secondary outcome [3] 401832 0
Costs (Oncologist-estimated mean time taken to deliver CIFeR; costs of printing CIFeR leaflet; Oncologist-estimated number of patients referred to psychologists or other psychosocial health professionals for help with FCR, as assessed on the follow-up survey on a 4-point Likert Scale), and through clinician interviews.
Timepoint [3] 401832 0
At the 3-month follow up survey and at study completion.
Secondary outcome [4] 401833 0
Feasibility (proportion of participating oncologists who report CIFeR to be feasible or very feasible in their practice) as assessed on a 4-point Likert Scale.
Timepoint [4] 401833 0
3 and 6 months after the CIFeR training.
Secondary outcome [5] 401834 0
Fidelity (proportion of the first three patients receiving CIFeR to whom all 5 components of CIFeR are delivered, as assessed by oncologist checklist self-report completed at the time of the consultation)
Timepoint [5] 401834 0
Within 6 months of CIFeR training.
Secondary outcome [6] 401835 0
Penetration: (percentage of oncologists informed about CIFeR who agree to and follow through with participating in the implementation study). Will be assessed through estimating number of oncologists approached (through snowballing recruitment techniques and professional membership advertisements) and the number who sign up and complete hte intervention.
Timepoint [6] 401835 0
At completion of study.
Secondary outcome [7] 401836 0
Sustainability: (proportion of participating oncologists who report having used CIFeR with at least one patient within the last 3 months, as assessed with a study-specific questionnaire, when surveyed 6-months after their CIFeR training.
Timepoint [7] 401836 0
6-months after their CIFeR training.
Secondary outcome [8] 401837 0
Barriers and facilitators to implementation generated from semi-structured qualitative interviews with oncologists. Qualitative data will be collected from oncologists six months after training at study completion.
Interviews will be semi-structure, audio recorded and transcribed verbatim and will take approximately 30 minutes.
Timepoint [8] 401837 0
6-months after CIFeR training.
Secondary outcome [9] 401838 0
Self-efficacy: (change in oncologists’ self-efficacy to manage FCR scores), using the self-efficacy questionnaire (SE-12).
Timepoint [9] 401838 0
From baseline to immediately upon completion of the training module, and at 3 and 6-months after the training

Eligibility
Key inclusion criteria
1) Currently practising Medical and Radiation oncologists and surgeons and senior trainees (with > 6 months training in clinical oncology at the time of recruitment) who treat women with early stage breast cancer.
2) Ability to commit to the study requirements and undertake online CIFeR training modules
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 37 oncologists delivering the intervention will rule out an unfavourable feasibility rate of 50% for a more favourable response rate of 75%, with 80% power, based on a one-sided 5% significance level. Expecting a dropout rate of ~25%, the study will recruit 50 Oncologists in total, with expected data to be available from 37 oncologists in order to evaluate intervention feasibility.
Measures of Proctor outcomes (e.g. intervention adoption, acceptability) will be reported using descriptive statistics including proportions, means and standard deviations. Baseline demographics will be summarized in table format. T-tests will be used to examine changes in oncologist self-efficacy scores pre- and post-intervention.
Missing data for the SE-12 will be handled in the following manner, as there are no pre-specified instructions available. The average for the remaining items for the scale in question will be calculated with the adjusted denominator. For the acceptability questionnaires, all available data will be included for analysis. If Oncologists complete baseline and one (but not both) of the follow-up surveys (either 3 months or 6 months), data from the baseline and follow-up survey will still be included in the overall analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2022
Actual
1/03/2022
Date of last participant enrolment
Anticipated
1/05/2023
Actual
Date of last data collection
Anticipated
1/11/2023
Actual
Sample size
Target
50
Accrual to date
45
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 20725 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 35532 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 309768 0
Government body
Name [1] 309768 0
Sydney Health Partners
Country [1] 309768 0
Australia
Funding source category [2] 309909 0
Charities/Societies/Foundations
Name [2] 309909 0
The Sydney Breast Cancer Foundation
Country [2] 309909 0
Australia
Primary sponsor type
Hospital
Name
The Chris O'Brien Lifehouse
Address
119-143 Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 311037 0
None
Name [1] 311037 0
Address [1] 311037 0
Country [1] 311037 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309525 0
St Vincents Hospital Human Research Ethics Committee
Ethics committee address [1] 309525 0
Ethics committee country [1] 309525 0
Australia
Date submitted for ethics approval [1] 309525 0
08/10/2021
Approval date [1] 309525 0
25/11/2021
Ethics approval number [1] 309525 0

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

Contacts
Principal investigator
Name 114458 0
Dr Jia (Jenny) Liu
Address 114458 0
Kinghorn Cancer Centre, St Vincent’s Hospital
390 Victoria St
Darlinghurst Sydney NSW 2010
Country 114458 0
Australia
Phone 114458 0
+61293555655
Fax 114458 0
Email 114458 0
[email protected]
Contact person for public queries
Name 114459 0
Jia (Jenny) Liu
Address 114459 0
Kinghorn Cancer Centre, St Vincent’s Hospital
390 Victoria St
Darlinghurst Sydney NSW 2010
Country 114459 0
Australia
Phone 114459 0
+61293555655
Fax 114459 0
Email 114459 0
[email protected]
Contact person for scientific queries
Name 114460 0
Jia (Jenny) Liu
Address 114460 0
Kinghorn Cancer Centre, St Vincent’s Hospital
390 Victoria St
Darlinghurst Sydney NSW 2010
Country 114460 0
Australia
Phone 114460 0
+61293555655
Fax 114460 0
Email 114460 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
This is an implementation study.


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
EmbaseA novel clinician-delivered intervention to reduce fear of recurrence in breast cancer survivors: Results from a Phase I/II implementation study (CIFeR_2).2023https://dx.doi.org/10.1002/pon.6249
N.B. These documents automatically identified may not have been verified by the study sponsor.