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Trial registered on ANZCTR


Registration number
ACTRN12618001445268
Ethics application status
Approved
Date submitted
20/08/2018
Date registered
28/08/2018
Date last updated
27/02/2020
Date data sharing statement initially provided
3/12/2018
Date results provided
6/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
BreastScreen Anxiety (BSAnx) Feasibility Study
Scientific title
BreastScreen Anxiety (BSAnx) Feasibility Study: time-clustered randomised controlled trial using novel delivery methods of information to reduce anxiety in women recalled for further tests following screening mammography.
Secondary ID [1] 294128 0
None
Universal Trial Number (UTN)
U1111-1209-6746
Trial acronym
BSAnx feasibility study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety associated with a recall for further tests following screening mammography 306742 0
Condition category
Condition code
Mental Health 305834 305834 0 0
Anxiety
Cancer 308209 308209 0 0
Breast
Public Health 308210 308210 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study uses two novel consumer-friendly delivery methods of information. The information delivered will be current statistical information published by BreastScreen Australia, which states that of 1000 women screened, 45 will be asked to return for further tests following the screening mammogram. Of this 45, 39 will receive a normal result and 6 women will be diagnosed with breast cancer.
The intervention will be the use of combined verbal (by phone) and written (by email) information, to assess which consumer-friendly delivery method is most effective in reducing levels of anxiety.
Participants in the intervention group will receive the intervention when notified of the need for the further tests, by a BreastScreen Nurse Counsellor. The verbal information will be provided in the same phone call, and the written intervention will be provided immediately after the phone call.
The verbal intervention will be scripted, with Nursing staff following a pre-prepared intervention script. Only the intervention information will be scripted, normal core business processes will be followed when notifying women of the need for further tests - the intervention is designed to be considered as additional information provided to clients.
The written intervention is a graphical demonstration of the current statistical rates of screening false positive and cancer detection rates in women recalled for further tests. This graphic is a published graphic by BreastScreen Australia.
The email will be sent from a generic BreastScreen ACT email account, monitored by a single administrative personnel. Read receipts will be requested.
Intervention code [1] 300413 0
Behaviour
Comparator / control treatment
The control group will receive current standard practice of BreastScreen ACT.

The control group will be notified of the need for further tests via a phone call from a trained Nurse Counsellor. They will be given the standard information given to all women recalled for further tests, including information about the appointment date and time, further tests that may be performed at the appointment, parking, clothing and length of appointment. This is standard practice.
Control group
Active

Outcomes
Primary outcome [1] 305215 0
Depression Anxiety and Stress Scale - 21 Items (DASS-21)
Timepoint [1] 305215 0
Immediately prior to the screening mammogram.

Assessing levels of anxiety immediately prior to the mammogram will provide valuable information relating to a woman's levels of anxiety prior to undergoing mammography, Thsi will also provide a baseline anxiety level.
Secondary outcome [1] 344522 0
Depression Anxiety and Stress Scale - 21 Items (DASS-21)
Timepoint [1] 344522 0
Immediately prior to the recall for further tests appointment
Secondary outcome [2] 351112 0
Assessment of feasibility outcomes:
- recruitment and retention rates
- sample size assumptions
Timepoint [2] 351112 0
Recruitment: time point 1 (immediately prior to screening mammogram)
Retention: time point 2 (at the further tests appointment)

Sample size assumptions: post data collection.
Secondary outcome [3] 380641 0
Understanding of Screening False Positive Result: a short multiple choice question.
Question: What id your understanding of a screening false positive result?
a) You have been diagnosed with cancer, but no cancer is actually present
b) You undergo further tests, but no cancer is detected
c) You undergo further tests and cancer is detected
d) I am not sure
e) Other
Timepoint [3] 380641 0
Phase Two (Recalled for Assessment: After)

Eligibility
Key inclusion criteria
All women eligible for a free screening mammogram with BreastScreen ACT and literate in English will be invited to participate in this feasibility study.
Minimum age
40 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Due to the nature of the survey requirements, only women over the age of 40 who are literate in English can participate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No Allocation Concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Time-clustered randomisation. Participants will be placed in the control/intervention group defined by which week they attend the BreastScreen ACT follow-up clinic. Participants will be placed in follow-up clinic at random, which will outline which group the participant will be allocated.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This feasibility study follows a pragmatic approach to test a large scale 2 x 2 factorial designed study. Using two groups (control vs intervention) this feasibility study will inform the methodology of the large scale study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Feasibility analysis:
• Recruitment and retention of participants will be calculated by the number of participants participating in time point 1; and retention of participants at time point 2.
• Methodology: successful methodology will be achieved if streamlined intervention process are achieved. A register will be used to outline issues that arise and resolutions, as well as adaptations to the methodology required.
• Sample size assumptions: assessment of pilot data of mean values, SD and test of normality will inform our sample size assumptions for BSAnx.
• Assessment of potential cross contamination of information between participants and study groups.
Pilot data analysis:
• Demographic data presented as descriptive statistics. Linear models to test group differences and to control for possible confounding variables. Nominal data will be evaluated using Chi squared test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2019
Actual
4/02/2019
Date of last participant enrolment
Anticipated
Actual
4/04/2019
Date of last data collection
Anticipated
Actual
4/04/2019
Sample size
Target
4000
Accrual to date
Final
1583
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 22181 0
2606 - Phillip
Recruitment postcode(s) [2] 22182 0
2601 - City
Recruitment postcode(s) [3] 22183 0
2617 - Belconnen

Funding & Sponsors
Funding source category [1] 298765 0
University
Name [1] 298765 0
University of Canberra
Country [1] 298765 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
UC College
LPO Box 5066
University of Canberra
BRUCE ACT 2617
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 297949 0
None
Name [1] 297949 0
Address [1] 297949 0
Country [1] 297949 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299704 0
ACT Health HREC
Ethics committee address [1] 299704 0
Ethics committee country [1] 299704 0
Australia
Date submitted for ethics approval [1] 299704 0
10/09/2018
Approval date [1] 299704 0
20/11/2018
Ethics approval number [1] 299704 0
ACT Health HREC protocol number: 2018/LRE/00172
Ethics committee name [2] 302088 0
University of Canberra HREC
Ethics committee address [2] 302088 0
Ethics committee country [2] 302088 0
Australia
Date submitted for ethics approval [2] 302088 0
22/11/2018
Approval date [2] 302088 0
23/11/2018
Ethics approval number [2] 302088 0
Project ID: 20181686

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

Contacts
Principal investigator
Name 81346 0
Prof Rob Davidson
Address 81346 0
UC College, LPO Box 5066, University of Canberra, BRUCE ACT 2617, AUSTRALIA
Country 81346 0
Australia
Phone 81346 0
+61 2 6201 5809
Fax 81346 0
Email 81346 0
Rob.Davidson@canberra.edu.au
Contact person for public queries
Name 81347 0
Rob Davidson
Address 81347 0
UC College, LPO Box 5066, University of Canberra, BRUCE ACT 2617, AUSTRALIA
Country 81347 0
Australia
Phone 81347 0
+61 2 6201 5809
Fax 81347 0
Email 81347 0
Rob.Davidson@canberra.edu.au
Contact person for scientific queries
Name 81348 0
Rob Davidson
Address 81348 0
UC College, LPO Box 5066, University of Canberra, BRUCE ACT 2617, AUSTRALIA
Country 81348 0
Australia
Phone 81348 0
+61 02 6201 5809
Fax 81348 0
Email 81348 0
Rob.Davidson@canberra.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
This is only a 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.