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Trial registered on ANZCTR


Registration number
ACTRN12618001615279
Ethics application status
Approved
Date submitted
27/09/2018
Date registered
2/10/2018
Date last updated
11/02/2021
Date data sharing statement initially provided
28/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinician Intervention to Reduce Fear of Recurrence in Cancer Survivors (CIFeR Study)
Scientific title
Clinician Intervention to Reduce Fear of Recurrence in Cancer Survivors (CIFeR Study)
Secondary ID [1] 296192 0
Nil known
Universal Trial Number (UTN)
U1111-1221-2559
Trial acronym
CIFeR Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 309831 0
fear of cancer recurrence 309832 0
Condition category
Condition code
Cancer 308621 308621 0 0
Breast
Mental Health 308626 308626 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a phase 1 feasibility study of a novel education and communication intervention delivered by medical oncologists to breast cancer survivors 6 months to 5 years after completion of their hospital-based treatments. A 5-component education/counselling intervention to address fear of cancer recurrence in breast cancer survivors will be used during a routine follow-up clinic appointment at hospital, and is expected to take around ten minutes to deliver. The intervention entails: 1) Fear of cancer recurrence (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 would like additional help.

The intervention entails:
- 10 minute discussion with the breast oncologist about level of FCR, impact on the patients life, and provision of reassurance and prognostic information about recurrence risk.
- Take home pamphlet which has been custom designed specifically for the study, providing advice on symptoms/signs that may suggest cancer recurrence and what to do about these, and advice on how to manage worry
- Mode of administration will be one-on-one between the breast oncologist and the patient
- Only the usual breast oncologist will administer the intervention
- The follow-up appointment where the interventionis being delivered will be audio recorded (with the patient's permission) to assess for intervention adherence as a secondary endpoint.

The 5-component intervention to be piloted in this study was developed by the investigators from our systematic review of existing interventions1 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).

1. 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
Intervention code [1] 312521 0
Treatment: Other
Comparator / control treatment
Nil. This is a single arm feasibility trial. All enrolled participants will receive the intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307580 0
Feasibility of the intervention as determined by patient acceptability. The outcome measure for feasibility is the proportion of eligible, consenting patients who rate the intervention as satisfactory (a score of 3 or higher on a 4-point Likert scale from 1 (unacceptable) to 4 (very acceptable)). The CIFeR intervention will be defined as feasible if greater than or equal to 65% of patients receive the intervention and rate it as acceptable, whereas the intervention will be unfeasible if <40% of patients receive the intervention or rate it as acceptable.
Timepoint [1] 307580 0
1 week after intervention delivery as rated by participants
Secondary outcome [1] 352357 0
Time taken: The proportion of interventions take an average of 10 minutes or less to complete, as measured by audio recording of the entire consultation, and subsequent decoding of the time taken for the intervention, where 75% or more is considered feasible
Timepoint [1] 352357 0
During intervention delivery
Secondary outcome [2] 352358 0
Intervention fidelity: The proportion of consultations where all 5 components of the intervention delivered. This will be assessed by audio recording the follow-up consultations where the intervention is being delivered. A research investigator will then audit adherence to the protocol.
Timepoint [2] 352358 0
During intervention delivery
Secondary outcome [3] 352359 0
Clinician satisfaction: The proportion of oncologists rating a score of greater than or equal to 3 on Likert scale from 0 (not feasible) to 4 (very feasible), where 75% or more is considered satisfactory
Timepoint [3] 352359 0
One month after study completion
Secondary outcome [4] 352360 0
Survey adherence: proportion of surveys completed by patients at baseline, one week and three months, where 75% or more is considered acceptable. This will be assessed by research investigators auditing survey completion rates for each patient at each timepoint.
Timepoint [4] 352360 0
Baseline, one week and three months after intervention delivery
Secondary outcome [5] 352361 0
Magnitude change in FCR from baseline to post-intervention (as rated by the validated 42-item FCR Inventory) which will be measured at baseline (up to 4 weeks prior to the intervention), 1 week post-intervention and 3 months post-intervention.
Timepoint [5] 352361 0
1 week post-intervention and 3 months post-intervention compared to baseline
Secondary outcome [6] 352362 0
Changes in patient rating of unmet needs: The proportion of patients with high (3) or very high (4) unmet needs at each timepoint (single item 5-point Likert-scale from 0 (very low) to 4 (very high)).
Timepoint [6] 352362 0
1 week post-intervention and 3 months post-intervention compared to baseline
Secondary outcome [7] 352363 0
Magnitude change in depression and anxiety scores from baseline to post-intervention (as rated on the validated DASS-21 score).
Timepoint [7] 352363 0
1 week post-intervention and 3 months post-intervention compared to baseline
Secondary outcome [8] 352364 0
Qualitative responses from patients and oncologists in semi-structured interviews exploring feasibility, logistics, intervention acceptability and usefulness and suggested changes. This is a composite secondary outcome, and will be evaluated in a descriptive fashion.
Timepoint [8] 352364 0
Single assessment between two week and two months from intervention delivery.
Secondary outcome [9] 352365 0
Impact of the intervention on psychologist referral rates and psychologist follow-up. This is a composite secondary outcome, assessed as the proportion of patients referred to psychology, and the proportion of referrals who attended the psychology appointment. This will be assessed using a study-specific questionnaire given to patients 3 months after the intervention, and verified using data-linkage to medical records.
Timepoint [9] 352365 0
Three months after intervention delivery

Eligibility
Key inclusion criteria
1) Women aged 18 years and above with histologically confirmed early stage (I-III inclusive) breast cancer who have undergone treatment with curative intent
2) Completed surgery and adjuvant chemotherapy/radiotherapy (where appropriate) greater than or equal to 6 months from time of registration (but may be on adjuvant hormone therapy)
3) Willing and able to complete study requirements including patient-rated outcome (PRO) surveys without assistance or translation
4) Completed signed written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Current severe major depression (as defined by >15 on DASS-21) and anxiety (>21 on DASS-21)
2) Current psychotic illness or other psychiatric/cognitive condition that would impair the ability to participate in the intervention (as judged by the treating clinician)
3) Patients who are unable to understand written or spoken English
4) Objective evidence of recurrence or metastatic cancer of any type, as determined by the treating oncologist.

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
A total of 24 patients receiving 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 pilot study will recruit 32 patients in total, with expected data to be available from 24 patients in order to evaluate intervention feasibility.

Measures of intervention acceptability, time taken for the intervention and intervention delivery will be reporting 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 FCR, depression, anxiety and patient acceptability scores pre- and post-intervention.
Missing data will be handled for the DASS-21 and the FCRI as prespecified in the appropriate user manuals e.g. 1 missing item per 7-item scale for DASS-21 permitted. 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 patients complete baseline and one (but not both) of the follow-up surveys (either 1 week or 3 months), data from the baseline and follow-up survey will still be included in the overall analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2018
Actual
1/04/2019
Date of last participant enrolment
Anticipated
1/06/2019
Actual
4/12/2019
Date of last data collection
Anticipated
1/09/2019
Actual
28/04/2020
Sample size
Target
32
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12026 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [2] 12027 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 24178 0
2050 - Camperdown
Recruitment postcode(s) [2] 24179 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 300782 0
Charities/Societies/Foundations
Name [1] 300782 0
AVANT Foundation
Country [1] 300782 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Psycho-Oncology Cooperative Group
Address
Level 6, Chris O'Brien Lifehouse 119-143 Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 300330 0
None
Name [1] 300330 0
Address [1] 300330 0
Country [1] 300330 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301565 0
Sydney Local Health Distriction Human Research Ethics Committee - Concord Repatriation General Hospital
Ethics committee address [1] 301565 0
Ethics committee country [1] 301565 0
Australia
Date submitted for ethics approval [1] 301565 0
02/10/2018
Approval date [1] 301565 0
27/11/2018
Ethics approval number [1] 301565 0

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

Contacts
Principal investigator
Name 87406 0
Dr Jia (Jenny) Liu
Address 87406 0
Chris O'Brien Lifehouse
119-143 Missenden Rd
Camperdown NSW 2050
Country 87406 0
Australia
Phone 87406 0
+61 405 536 859
Fax 87406 0
Email 87406 0
jenny_jia_liu@hotmail.com
Contact person for public queries
Name 87407 0
Jia (Jenny) Liu
Address 87407 0
Chris O'Brien Lifehouse
119-143 Missenden Rd
Camperdown NSW 2050
Country 87407 0
Australia
Phone 87407 0
+61 405 536 859
Fax 87407 0
Email 87407 0
jenny_jia_liu@hotmail.com
Contact person for scientific queries
Name 87408 0
Jia (Jenny) Liu
Address 87408 0
Chris O'Brien Lifehouse
119-143 Missenden Rd
Camperdown NSW 2050
Country 87408 0
Australia
Phone 87408 0
+61 405 536 859
Fax 87408 0
Email 87408 0
jenny_jia_liu@hotmail.com

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 a pilot feasibility 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
No additional documents have been identified.