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Trial registered on ANZCTR


Registration number
ACTRN12617001163392
Ethics application status
Approved
Date submitted
28/07/2017
Date registered
8/08/2017
Date last updated
14/08/2019
Date data sharing statement initially provided
14/08/2019
Date results provided
14/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of reminder letters and phone calls in women's preferred language for improving breast cancer screening rates
Scientific title
Optimising breast screening in Melbourne’s North West through providing reminder letters and phone calls in language
Secondary ID [1] 292556 0
None
Universal Trial Number (UTN)
U1111-1199-9836
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 304210 0
Condition category
Condition code
Public Health 303553 303553 0 0
Other public health
Cancer 303626 303626 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to evaluate whether sending routine reminder letters and/ or reminder phone calls in a woman’s preferred language (Arabic or Italian) is associated with an increase in rates of booking a breast screening appointment. Women who have recorded their preferred language as either Arabic or Italian at their initial breast screening appointment with Breast Screen Victoria will receive their routine 2-yearly reminder letter to attend breast cancer screening in their preferred language (with English on the other side). In addition, women who are greater than 27 months since their last screen ("lapsed screeners") will be telephoned in their preferred language to remind them to book an appointment to screen and to assist them to book an appointment if required.
Participants will receive only one reminder letter and only one phone call.
Intervention code [1] 298752 0
Early detection / Screening
Comparator / control treatment
For the routine reminder letters in preferred language, the control group will continue to receive their reminder letter Breast Screen Victoria in English, as per usual practice.
For the "lapsed screeners", the control group will not receive any intervention (Breast Screen Victoria do not routinely telephone lapsed screeners).
Control group
Active

Outcomes
Primary outcome [1] 302921 0
Proportion of women who book at breast cancer screening appointment within two weeks of letter/phone call, assessed by data linkage to the Breast Screen Victoria database
Timepoint [1] 302921 0
Within two weeks of the letter being mailed or of receiving the phone call
Secondary outcome [1] 373854 0
There is no secondary outcome
Timepoint [1] 373854 0
There is no secondary outcome

Eligibility
Key inclusion criteria
All women who live in the BSV screening region of North-west Melbourne who are eligible for breast cancer screening (i.e. not pregnant or breastfeeding, between age 50-74 years, not diagnosed with breast cancer in the last 5 years, and not had a breast screen within the last 2 years); and who have previously identified their preferred language as Italian or Arabic, and who: 1) are due to receive their 2-yearly routine reminder letter, or: 2) have not re-screened despite having received a routine reminder letter at least 3 months ago ("lapsed screener").
Minimum age
50 Years
Maximum age
74 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who do not indicate Italian or Arabic as their preferred language; women living outside the North West Melbourne catchment area; women not eligible for breast cancer screening.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size, routine reminder letter: For a pooled sample, the aim is to detect a 10% difference in screening rates between each intervention and the usual care group; a pooled sample size of 373 per intervention arm will be sufficient to detect this difference (based on 80% power and a Type 1 error rate of 5%). We are interested in sub-group analysis by cultural group, and as the number of Italian women due to be rescreened is approximately 30% higher than for Arabic women, this sample size can be randomly allocated as:
• Arabic women=160 in each arm. This will detect a 15% increase in screening rates (from a baseline screening rate of 56% ). Based on findings from other studies, it is reasonable to assume that this slightly higher response rate is achievable for Arabic women
• Italian women=213 in each arm. This will detect a 10-15% increase in screening rates.
Given the nature of the study design, there is no need to inflate the sample sizes to allow for drop out.
Sample size lapsed screeners: Lapsed screeners will be randomised to intervention and usual care. Assuming a conservative current screening rate of 10% for lapsed screeners (this rate is unknown by Breast Screen Victoria, but can by definition be assumed to be 0%), a 15% increase in screening (power=80% and Type 1 error rate=5%) would require a total pooled sample size of 200. Given that the number of Italian women is approximately 30% higher, this sample size can be allocated as:
• Arabic women=43 in each arm. This will detect a 25% increase in screening rates.
• Italian women=57 in each arm. This will detect between 20-25% increase in screening rates.
Analysis: For each cultural group, categorical data will be presented as frequencies and percentages. No continuous data will be collected for this study. Primary and secondary outcomes will be modelled as proportions. Differences between control and intervention groups will be analysed using chi-square.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/07/2017
Date of last participant enrolment
Anticipated
31/10/2017
Actual
4/12/2017
Date of last data collection
Anticipated
30/11/2017
Actual
22/12/2017
Sample size
Target
946
Accrual to date
Final
1042
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 297134 0
Government body
Name [1] 297134 0
Department of Health and Human Services, Victoria
Country [1] 297134 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
School of Health and Social Development, 221 Burwood Hwy, Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 296144 0
None
Name [1] 296144 0
Address [1] 296144 0
Country [1] 296144 0
Other collaborator category [1] 279662 0
Government body
Name [1] 279662 0
Breast Screen Victoria
Address [1] 279662 0
Level 1/31 Pelham St, Carlton VIC 3053
Country [1] 279662 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298304 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 298304 0
Ethics committee country [1] 298304 0
Australia
Date submitted for ethics approval [1] 298304 0
02/05/2017
Approval date [1] 298304 0
22/05/2017
Ethics approval number [1] 298304 0
2015-317

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

Contacts
Principal investigator
Name 76654 0
Dr Alison Beauchamp
Address 76654 0
Health Systems Improvement Unit
School of Health and Social Development
Deakin University
221, Burwood Hwy,
Burwood
Victoria 3125
Country 76654 0
Australia
Phone 76654 0
+61 3 92446517
Fax 76654 0
Email 76654 0
alison.beauchamp@deakin.edu.au
Contact person for public queries
Name 76655 0
Alison Beauchamp
Address 76655 0
Health Systems Improvement Unit
School of Health and Social Development
Deakin University
221, Burwood Hwy,
Burwood
Victoria 3125
Country 76655 0
Australia
Phone 76655 0
+61 3 92446517
Fax 76655 0
Email 76655 0
alison.beauchamp@deakin.edu.au
Contact person for scientific queries
Name 76656 0
Alison Beauchamp
Address 76656 0
Health Systems Improvement Unit
School of Health and Social Development
Deakin University
221, Burwood Hwy,
Burwood
Victoria 3125
Country 76656 0
Australia
Phone 76656 0
+61 3 92446517
Fax 76656 0
Email 76656 0
alison.beauchamp@deakin.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
These data belong to BreastScreen Victoria and sharing of these data may impact on women's perception of privacy surrounding the sensitive area of breast cancer screening.


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.