Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000001695
Ethics application status
Approved
Date submitted
19/12/2022
Date registered
9/01/2023
Date last updated
20/02/2024
Date data sharing statement initially provided
9/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Screening participant and health service impact of population-based breast density notification in Australia: a randomised controlled trial in BreastScreen Queensland
Scientific title
Screening participant and health service impact of population-based breast density notification in Australia: a randomised controlled trial in BreastScreen Queensland
Secondary ID [1] 308459 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 328262 0
Condition category
Condition code
Cancer 325306 325306 0 0
Breast
Public Health 325307 325307 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1 (study arm 2) - n=952: Women attending a BreastScreen Queensland Sunshine Coast service will have their breast density assessed. Those who are classified into BI-RADS category C or D (heterogeneously dense and extremely dense) will be randomised. Intervention 1 will include a notification of breast density plus a hard-copy written insert including health literacy sensitive breast density information. Participants will receive their breast density notification within the standard mammogram outcome letter sent by BreastScreen Queensland approximately 4-6 weeks following their mammogram. An additional insert will be included in this letter that is health literacy sensitive (lay language with a grade 8 reading level or below) and provides additional information about breast density. Staff at BreastScreen Queensland will send the letter and additional insert to participants at their home address or email address (as preferred). Participants will then be contacted by the researchers at 8-weeks, 12-months and 27-months to collect self-reported data via an online questionnaire. At 8-weeks participants in Intervention 1 (study arm 1) will also indicate whether their willingness to participate in the longitudinal qualitative sub-study component of the trial where n=30 women will be involved in a series of short semi-structured telephone interviews at 8-10 weeks, 12-months and 27-months. Women will be purposively selected from those willing to participate to ensure a range of sociodemographic characteristics and responses.

Intervention 2 (study arm 3) - n=952: Women attending a BreastScreen Queensland Sunshine Coast service will have their breast density assessed. Those who are classified into BI-RADS category C or D (heterogeneously dense and extremely dense) will be randomised. Intervention 2 will include a notification of breast density plus online written and video-based health literacy sensitive breast density information. Participants will receive their breast density notification within the standard mammogram outcome letter sent by BreastScreen Queensland approximately 4-6 weeks following their mammogram. This letter will also include instructions (a link and QR code) to a short (~2 minute) online video with the identical information in a more conversational format. Staff at BreastScreen Queensland will send the letter with instructions to go online to participants at their home address or email address (as preferred). Women will then be contacted by the researchers at 8-weeks, 12-months and 27-months to collect self-reported data via an online questionnaire. At 8-weeks participants in Intervention 2 (study arm 3) will also indicate whether their willingness to participate in the longitudinal qualitative sub-study component of the trial where n=30 women will be involved in a series of short semi-structured telephone interviews at 8-10 weeks, 12-months and 27-months. Women will be purposively selected from those willing to participate to ensure a range of sociodemographic characteristics and responses.
Intervention code [1] 324905 0
Behaviour
Comparator / control treatment
Control (study arm 1) - n=952: Standard care in BreastScreen Australia. Current standard care in the majority of Australian states is to not measure breast density on mammography or notify women if they have dense breasts. Participants in the control (study arm 1) will be women classified as having dense breasts as per BI-RADS category C or D (heterogeneously dense and extremely dense) and not receive notification of their breast density, nor will they receive additional breast density information. They will receive the standard letter notifying them of the outcome of their mammogram, sent by staff at BreastScreen Queensland to their home address or email address (as preferred). Women will then be contacted by the researchers at 8-weeks, 12-months and 27-months to collect self-reported data via an online questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 333177 0
Anxiety

The following item will be used to measure anxiety.

Please indicate the extent of your agreement or disagreement with the following statements.
Receiving this letter does/would make me feel anxious (uneasy, worried, nervous)
4-point scale (1 = ‘strongly agree’ to 4 = ‘strongly disagree’).

Reference: Rhodes DJ, Jenkins SM, Hruska CB, Vachon CM, Breitkopf CR. Breast Density Awareness, Knowledge, and Attitudes Among US Women: National Survey Results Across 5 Years. Journal of the American College of Radiology. 2020;17(3):391-404
Timepoint [1] 333177 0
8-weeks (primary endpoint), 12-months, 27-months post-mammogram.
Primary outcome [2] 333178 0
Health service use (GP visitation)

Health service use in terms of GP visitation will be measured using the following items (depending on time of measurement):

After recently receiving your screening mammogram result letter, are you planning to talk to your GP about it? (Timepoint 1: intention)
Yes/No/Don't know

Since receiving the screening mammogram result letter about 1 year ago, have you spoken to your GP about it? (Timepoints 2 and 3: actual use)
Yes/No/Don't know

Reference: Dolan H, McCaffery K, Houssami N, Cvejic E, Brennan M, Hersch J, et al. Australian Women's Intentions and Psychological Outcomes Related to Breast Density Notification and Information: A Randomized Clinical Trial. JAMA Netw Open. 2022;5(6):e2216784
Timepoint [2] 333178 0
Intention: 8-weeks post-mammogram.
Actual use: 12-months (primary endpoint) and 27-months post-mammogram.
Primary outcome [3] 333179 0
Health service use (supplemental screening)

Health service use in terms of supplemental screening is a composite outcome comprising of five elements: intention to go for/actual use of supplemental screening, choice of extra tests, willingness to pay/actual paying out of pocket, the outcome of any supplemental screening, and frequency of supplemental screening.

For Timepoint 1 (intention): Participants will be asked if they would go for extra tests (supplemental screening) after receiving their mammogram result letter (Yes/No/Don't know). If they choose yes, they will be further prompted to choose which extra test (ultrasound, MRI, ultrasound and MRI, digital breast tomosynthesis, other, don't know). Participants will also be asked if they are willing to pay out of pocket for supplemental screening.

For Timepoints 2 and 3 (actual use): Participants will be asked if they have gone for extra tests (supplemental screening) after receiving their mammogram result letter (Yes/No/Don't know). If they choose yes, they will be further prompted to choose which extra test (Ultrasound, MRI, Ultrasound and MRI, Digital breast tomosynthesis, Other, Don't know). They will also be asked the outcome of the further screening (Negative result - no abnormalities detected/Positive result - DCIS or breast cancer detected/Further investigation was required - e.g. needle biopsy/Unsure), the frequency of tests they attended (1-2/3-4/5-6/7+), and if they paid for the extra screening out of pocket (Yes/No/Don't know).

Reference: Dolan H, McCaffery K, Houssami N, Cvejic E, Brennan M, Hersch J, et al. Australian Women's Intentions and Psychological Outcomes Related to Breast Density Notification and Information: A Randomized Clinical Trial. JAMA Netw Open. 2022;5(6):e2216784
Timepoint [3] 333179 0
Intention: 8-weeks post-mammogram.
Actual use: 12-months (primary endpoint) and 27-months post-mammogram.
Secondary outcome [1] 416060 0
Breast cancer worry.

The following item will be used to measure breast cancer worry:

How worried are you about developing breast cancer?
4-point scale (1 = 'not worried at all' to 4 = 'very worried').

Reference: Sutton S, Bickler G, Sancho-Aldridge J, Saidi G. Prospective study of predictors of attendance for breast screening in inner London. J Epidemiol Community Health. 1994;48(1):65-73.
Timepoint [1] 416060 0
8-weeks, 12-months, 27-months post-mammogram.
Secondary outcome [2] 416063 0
Breast cancer perceived risk

The following item will be used to measure the participants' perceived risk of breast cancer:

Compared to other women your age, race and sex, what do you think is your chance of getting breast cancer in your lifetime?
3-point scale (1 = 'above average' to 3 = 'below average').

Reference: Lipkus IM, Kuchibhatla M, McBride CM, Bosworth HB, Pollak KI, Siegler IC, et al. Relationships among breast cancer perceived absolute risk, comparative risk, and worries. Cancer Epidemiol Biomarkers Prev. 2000;9(9):973-5
Timepoint [2] 416063 0
8-weeks, 12-months, 27-months post-mammogram.
Secondary outcome [3] 416355 0
Breast density knowledge

Breast density knowledge is a composite outcome comprising of five elements derived from quantitative questionnaire questions/measures used in previous studies: what breast density means (1,2), knowledge of the percentage of women with dense breasts (3,4), knowledge that breast density increases the risk of breast cancer (3,4), knowledge of the impact of dense breasts on mammographic ability to detect cancer (3,4), and knowledge of breast density changes with age (3,4).

References: 1) Kressin NR, Wormwood JB, Battaglia TA, et al. Differences in Breast Density Awareness, Knowledge, and Plans Based on State Legislation Status and Sociodemographic Characteristics. J Gen Intern Med 2020;35(6):1923-25. doi: 10.1007/s11606-019-05578-3
2) Kressin NR, Wormwood JB, Battaglia TA, et al. Women's Understandings and Misunderstandings of Breast Density and Related Concepts: A Mixed Methods Study. J Womens Health (Larchmt) 2022;31(7):983-90. doi: 10.1089/jwh.2021.0343
3) Rhodes DJ, Jenkins SM, Hruska CB, Vachon CM, Breitkopf CR. Breast Density Awareness, Knowledge, and Attitudes Among US Women: National Survey Results Across 5 Years. Journal of the American College of Radiology. 2020;17(3):391-404
4) Dolan H, McCaffery K, Houssami N, Cvejic E, Brennan M, Hersch J, et al. Australian Women's Intentions and Psychological Outcomes Related to Breast Density Notification and Information: A Randomized Clinical Trial. JAMA Netw Open. 2022;5(6):e2216784
Timepoint [3] 416355 0
8-weeks, 12-months, 27-months post-mammogram.
Secondary outcome [4] 416356 0
Future intention and actual use of mammography screening.

Future intention and actual use of mammography screening is a composite outcome comprising of 3 elements: intention to change and actual change in frequency of mammograms, dependency of decision on GP recommendation, and the outcome of mammograms.

For Timepoint 1 (intention)*: Participants will be asked if they intend on changing how often they will go for screening mammograms (Yes/No/Don't know). If they choose yes, they will be further prompted to choose whether they will go for mammograms more or less often. If they choose don't know, they will be asked whether their decision depends on GP recommendation (True/False).

For Timepoints 2 and 3 (actual use): Participants will be asked if they have attended a screening mammogram in the past year (Yes/No/Unsure). If they choose yes, they will be asked the outcome (Negative result - no abnormalities detected/Positive result - DCIS or breast cancer detected/Further investigation was required - e.g. needle biopsy/Unsure), and if they have changed how often they go for mammograms (Yes - more often/Yes - less often/No/Unsure). If participants select no or unsure, they will be asked if they are planning to change how often they go for screening mammograms (Yes/No/Unsure).

Reference: Dolan H, McCaffery K, Houssami N, Cvejic E, Brennan M, Hersch J, et al. Australian Women's Intentions and Psychological Outcomes Related to Breast Density Notification and Information: A Randomized Clinical Trial. JAMA Netw Open. 2022;5(6):e2216784
Timepoint [4] 416356 0
Future intention: 8-weeks and 12-months post-mammogram.
Actual use: 12-months and 27-months post-mammogram.
Secondary outcome [5] 416357 0
Acceptability (subjective): The following items will be used to measure acceptability subjectively: Did you find your breast screening result letter and information within easy to understand? 5-point scale (1 = 'Strongly agree' to 5 = 'Strongly disagree') Did you find your breast screening result letter and information accessible (easy to access)? 5-point scale (1 = 'Strongly agree' to 5 = 'Strongly disagree') Reference: Sekhon M, Cartwright M, Francis JJ. Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions. BMC Health Serv Res. 2022;22(1):279.
Timepoint [5] 416357 0
8-weeks post-mammogram.
Secondary outcome [6] 416358 0
Acceptability (objective): Acceptability will also be measured objectively by measuring the women who are eligible for the study, and also the women who consent to being involving the the study.
Timepoint [6] 416358 0
0-weeks (at mammogram appointment).

Eligibility
Key inclusion criteria
Women attending BreastScreen Queensland (at locations in Sunshine Coast Hospital and Health Service).
Women with dense breasts (BI-RADS breast density categories C or D).
Women sufficiently fluent in English to understand study materials and complete telephone interviews.
Minimum age
40 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who do not have dense breasts (BI-RADS breast density categories A or B).
Women recalled with screen-detected abnormalities.
Personal history of breast cancer or ductal carcinoma in-situ.
Women reporting physical breast symptom/s at screening appointment, or radiographer recognises symptom during screening appointment.
Women who cannot consent to breast screening.
Women who require an interpreter (self-reported on breast screening booking system).
Women who do not have a mobile phone number or email address.

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 will be concealed via central randomisation by computer on the BreastScreen database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. Excel).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size calculations were performed based on the values obtained in a hypothetical scenario RCT, and assuming that approximately 15% of women in the control group have positive intentions to undergo supplemental screening or report feeling anxious (agree or strongly agree). To achieve 80% power to detect differences as small as 10% (at an adjusted alpha level of 0.013 to permit all 3 possible pairwise comparisons) in the primary outcomes between each of the notification arms and control would require n=373 women randomised to each arm (total N = 1119). As analyses will also be conducted longitudinally, this sample size will be inflated to allow for retention of approximately 80% at 8 weeks, and 70% retention at 1-year, and 70% retention at 24 months. As such, to maintain a total sample size of 1119 by 24 months would require initial recruitment at baseline of 2856 women (952 randomised to each group).

Missing data will be accounted for by complete case analysis. Sensitivity analyses will be conducted to assess the robustness of the results.

Descriptive statistics (frequency and relative frequency for categorical variables; mean and standard deviation for continuous variables) will be used to report participant socio-demographic and health characteristics. Linear mixed models (LMM) and generalised LMMs will be used to analyse data.

An exploratory post-hoc analysis will also be conducted to see if there are any differences based on mode of delivery (hard-copy written or online written + video) in primary outcome measures.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/09/2023
Actual
18/09/2023
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
2856
Accrual to date
175
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 312702 0
Government body
Name [1] 312702 0
National Health and Medical Research Council
Country [1] 312702 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 314318 0
Other Collaborative groups
Name [1] 314318 0
BreastScreen Queensland
Address [1] 314318 0
15 Butterfield Street, Herston, QLD, 4006
Country [1] 314318 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312002 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 312002 0
Ethics committee country [1] 312002 0
Australia
Date submitted for ethics approval [1] 312002 0
11/01/2023
Approval date [1] 312002 0
02/03/2023
Ethics approval number [1] 312002 0
Ethics committee name [2] 313787 0
Sunshine Coast Hospital and Health Service Research Governance & Development
Ethics committee address [2] 313787 0
Ethics committee country [2] 313787 0
Australia
Date submitted for ethics approval [2] 313787 0
09/05/2023
Approval date [2] 313787 0
02/08/2023
Ethics approval number [2] 313787 0
SSA/2023/QSC/89770

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

Contacts
Principal investigator
Name 123134 0
Dr Brooke Nickel
Address 123134 0
Room 127A, Edward Ford Building (A27),
The University of Sydney, Faculty of Medicine and Health,
Camperdown NSW 2006
Country 123134 0
Australia
Phone 123134 0
+61 02 9351 7829
Fax 123134 0
Email 123134 0
[email protected]
Contact person for public queries
Name 123135 0
Brooke Nickel
Address 123135 0
Room 127A, Edward Ford Building (A27),
The University of Sydney, Faculty of Medicine and Health,
Camperdown NSW 2006
Country 123135 0
Australia
Phone 123135 0
+61 02 9351 7829
Fax 123135 0
Email 123135 0
[email protected]
Contact person for scientific queries
Name 123136 0
Brooke Nickel
Address 123136 0
Room 127A, Edward Ford Building (A27),
The University of Sydney, Faculty of Medicine and Health,
Camperdown NSW 2006
Country 123136 0
Australia
Phone 123136 0
+61 02 9351 7829
Fax 123136 0
Email 123136 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
In line with our ethics application, participant's quantitative data will be made anonymous and will be aggregated for the purpose of statistical analyses. Findings will be reported at the group/condition level rather than the individual participant level. Qualitative data will also be reported at the group/condition level and a few selected individual de-identified quotes will be used in the reports and publications to illustrate common and diverse responses.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21694Study protocolNickel B, Ormiston-Smith N, Hammerton L, Cvejic E, Vardon P, Mcinally Z, Legerton P, Baker K, Isautier J, Larsen E, Giles M, Brennan M, McCaffery K, Houssami N. Psychosocial outcomes and health service use after notifying women participating in population breast screening when they have dense breasts: a BreastScreen Queensland randomised controlled trial. MJA, 2023. doi: 10.5694/mja2.52117https://www.mja.com.au/journal/2023/219/9/psychosocial-outcomes-and-health-service-use-after-notifying-women-participating 



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePsychosocial outcomes and health service use after notifying women participating in population breast screening when they have dense breasts: a BreastScreen Queensland randomised controlled trial.2023https://dx.doi.org/10.5694/mja2.52117
N.B. These documents automatically identified may not have been verified by the study sponsor.