Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Web platform with a multilevel information and an aid for the decision to be taken. The content is splitted in 16-20 screens; each screen contains the answer to a common question (i.e. What is mammography screening? What are its benefits and harms? What results can be expected from the participation to mammography screening? What is breast cancer?). The information covers also controversial topics as overdiagnosis, overtreatment and the disagreement among scientists about harms and benefits' quantification.

Decision-aid

Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.

Standard information

The present study aim to assess the effect of an interactive web decision aid on informed choice - measured via knowledge, attitudes and intentions concerning breast cancer screening - comparing the decision aid with a standard information provided via web.

Breast cancer is the most common cancer in women. In Italy, women are invited to a population-based mammography screening programme for the first time at the age of 45 or 50 years. Results from randomised controlled trials, observational studies, and systematic reviews continuously fuel the debate on the balance on benefits (reducing breast cancer mortality) and harms (overdiagnosis, overtreatment) of mammography screening. Physicians, policy makers, as well as laypeople or patient associations agree on the need to inform women about the potential benefits and harms in order to allow an aware decision process. Decision aids are an effective way to support lay people in their decisions about health.

Decision-aid on Breast Cancer Screening

New Invited Women to Breast Cancer Screening: a Multi-centre, Longitudinal, Controlled, Randomised Study on a Decision-aid to Support Informed Choice

Knowledge will be measured using a questionnaire structured in 13 questions with multiple choice answers, with 2 to 4 options. Ten questions will be qualitative and 3 will be numerical. A score of 8 out of 13 (about 60%) or higher would be considered "adequate knowledge".

Attitude will be measured through a scale of 6 items with 5 response options from 1 to 5, with a total score from 6 to 30. The investigators set the threshold for a positive attitude at 24 and consequently the score \<24 point a negative attitude.

Intention will be measured using 1 item with 5 responses: Definitely will, Likely to, Unsure, Not likely to, Definitely will not. The investigators classified "definitely will" and "likely to" as positive intentions.

Participation rate to the breast cancer screening programme will be assessed as a percentage of participants who actually participate, both in intervention and in the control group.

Satisfaction with the given information will be measured using 8 items with three points scale.

Number of click on the Homepage will be assessed trough Pickwick software.

Number of Times Web Platforms were Accessed assessed trough Pickwick software

Number of Pages Visited on the Web Platforms on the web decision aid assessed trough Pickwick software.

Decisional conflict will be assessed using the validated and widely used Decisional Conflict Scale-SURE version, consisted in four-item scale.

Mario Negri Institute for Pharmacological Research

The aim of this study is the efficacy of a decision-aid on mammography screening. This is not a pharmacological trial, enrolled patients have access to two different kind of web information. Therefore the safety was not considered in this trial and none of the participating women can be considered at risk of adverse effects. .

Decision-aid: Web platform with a multilevel information and an aid for the decision to be taken. The content is splitted in 16-20 screens; each screen contains the answer to a common question (i.e. What is mammography screening? What are its benefits and harms? What results can be expected from the participation to mammography screening? What is breast cancer?). The information covers also controversial topics as overdiagnosis, overtreatment and the disagreement among scientists about harms and benefits' quantification.

Standard information: Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.

Standard Information

Total

Age, Continuous

Sex: Female, Male

Italian

Other

Missing

Race/Ethnicity, Customized

Unmarried

Married or cohabitant

Separated or divorced

Widowed

Marital status

Elementary

Lower middle

Higher middle

Degree

Education

Paid work

No paid work

Employment status

The response rate was lower than expected, and there were about 50% dropouts. We invited more women than expected (21,014 versus 8,160). This high proportion of dropouts could be also due to scarce attention of women to comply with this type of study

Dr. Paola Mosconi and Dr. Anna Roberto

Number of Participants With Adequate Knowledge

Attitude

Intention

Participants who had already had a mammogram in the past 6 months were excluded from this dataset.

Participation Rate to the Breast Cancer Screening Programme

Too much

Too little

Fair

Satisfaction with the information given (intervention and control group) will be measured using 8 items regarding length, quantity, clarity, balance, helpfulness in making decision and women willingness to recommend it to other women with three points scale

Satisfaction With the Information Measured Using 8 Items With Three Points Scale

Number of Click on the Homepage

Number of Times Web Platforms Were Accessed

This outcome has been measured only for the interventional arm (Web Decision-aid is splitted in 16-20 screens) because the control arm was just a single webpage.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Decision-aid on Breast Cancer Screening	NCT03097653	Breast Cancer	Decision-aid Standard inform...	45 Years - 69 Years	Mario Negri Institute for Pharmacological Research
Decision-aid on Breast Cancer Screening	NCT03097653	Breast Cancer	Decision-aid Standard inform...	45 Years - 69 Years	Mario Negri Institute for Pharmacological Research

Spots Global Cancer Trial Database for national cancer screening program