Category
»
Primary study
Registry of Trials»ANZCTR
Year
»
2023
INTERVENTION: The aim of this study is to investigate the impact of information that provides older women with a rationale for no longer being invited to participate in the BreastScreen program on informed choice and psychological outcomes (worry, perceived risk). The design of the study is 3x1, a randomised trial with 3 arms. The trial will be conducted online through the Qualtrics survey platform. An online sample of older women living in Australia will be recruited through a large social research organisation that utilises panels. Eligible participants will be women aged 70‐74 years with no personal history of breast cancer or ductal carcinoma in situ (DCIS) who have screened for breast cancer at least once in the past 5 years. Eligible women will be presented with a hypothetical scenario. They will be asked to imagine they have gone for a routine mammogram screening and are now receiving a letter with their results. Participants will then be randomised to one of three letters. Group 1 (control): the final letter women receive from Breast Screen that highlights women are invited for screening from 50 to 74 years and shows a "negative" result ‐ i.e., no breast cancer could be seen on the mammogram. Group 2 (control + intervention 1): final BreastScreen letter + brief text informing women they will no longer receive reminders to screen because associated risks outweigh the benefits. This information will include the main points in brief dot‐point form that are covered in the animation video (intervention 2) and will be developed by the research team (including experts in health communication, breast physicians, a general practitioner and geriatrician, and older female consumers) in collaboration with BreastScreen NSW. Group 3 (control + interve CONDITION: Breast cancer screening; ; Breast cancer screening Cancer ‐ Breast Public Health ‐ Other public health PRIMARY OUTCOME: Informed choice.; ; This is a composite outcome comprising of three elements (from Qualtrics survey): intention to screen beyond 74 years, conceptual knowledge and screening attitudes. ; ; Hersch J, Barratt A, Jansen J, Irwig L, McGeechan K, Jacklyn G, Thornton H, Dhillon H, Houssami N, McCaffery K. Use of a decision aid including information on overdetection to support informed choice about breast cancer screening: a randomised controlled trial. The Lancet. 2015 Apr 25;385(9978):1642‐52.[Immediately after intervention] INCLUSION CRITERIA: Women living in Australia aged 70‐74 years, screened for breast cancer at least once in the past 5 years. SECONDARY OUTCOME: Cancer worry ‐ How worried would you be about developing breast cancer after receiving this letter? (from Qualtrics survey ; ; Sutton S, Bickler G, Sancho‐Aldridge J, et al. Prospective study of predictors of attendance for breast screening in inner London. Journal of Epidemiology & Community Health 1994;48(1):65‐73.[Immediately after intervention] Emotion ‐ BERRI (Petrova et al., 2022): ; How do you feel about this letter from BreastScreen? (from Qualtrics survey) ; ; Petrova D, Cokely ET, Sobkow A, Traczyk J, Garrido D, Garcia‐Retamero R. Measuring feelings about choices and risks: The Berlin Emotional Responses to Risk Instrument (BERRI). Risk Anal. 2022 May 23. doi: 10.1111/risa.13946. Epub ahead of print. PMID: 35606164.[Immediately after intervention] Intention to speak to GP (yes/no/don't know) ‐ from Qualtrics survey ; After receiving this letter, would you plan to talk to your GP about it? ; ; Dolan H, McCaffery K, Houssami N, Cvejic E, Brennan M, Hersch J, Dorrington M, Verde A, Vaccaro L, Nickel B. Australian Women’s intentions and psychological outcomes related to breast density notification and information: a randomized clinical trial. JAMA network open. 2022 Jun 1;5(6):e2216784‐.[Immediately after intervention] Intention to talk to GP (free‐text) ‐ What is one question you might like to ask your GP? (from Qualtrics survey)[Immediately after intervention] Perceived risk (from Qualtrics survey) ; Compared to other women your age, race and sex, what do you think is your chance of getting breast cancer in your lifetime if you received this letter? ; ; Lipkus IM, Kuchibhatla M, McBride CM, et al. Relationships among Breast Cancer Perceived Absolute Risk, Comparative Risk, and Worries. Cancer Epidemiology Biomarkers & Prevention 2000;9(9):973‐75 ; [Immediately after intervention]
Epistemonikos ID: 2feda265fbe2fc0fd2f59646e83c93de20b7a809
First added on: Feb 20, 2024