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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision-aid | Experimental |
| |
| Standard information | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision-aid | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adequate Knowledge | 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". | 7-10 days |
| Attitude | 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. | 7-10 days |
| Intention | 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. | 7-10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Participation Rate to the Breast Cancer Screening Programme | 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. | 15-60 days |
| Satisfaction With the Information Measured Using 8 Items With Three Points Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Screening Unit, Cancer Prevention and Research Institute - ISPO | Florence | Italy | ||||
| UOC Medicina Preventiva delle Comunità - Screening |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28629329 | Background | Roberto A, Colombo C, Candiani G, Giordano L, Mantellini P, Paci E, Satolli R, Valenza M, Mosconi P. Personalised informed choice on evidence and controversy on mammography screening: study protocol for a randomized controlled trial. BMC Cancer. 2017 Jun 19;17(1):429. doi: 10.1186/s12885-017-3428-9. | |
| 32546834 | Result |
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Date of first enrollment: September 2017 Date of last invitation: 31 December 2018 End of study: April 2019
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| ID | Title | Description |
|---|---|---|
| FG000 | Decision-aid | 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. |
| FG001 | Standard Information | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Decision-aid | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adequate Knowledge | 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". | Posted | Number | participants | 7-10 days |
|
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.
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. .
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Decision-aid | 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. |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paola Mosconi and Dr. Anna Roberto | Istituto di Ricerche Farmacologiche Mario Negri IRCCS | +390239014503 | donnainformata-mammografia@marionegri.it; paola.mosconi@marionegri.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2018 | May 18, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| Standard information | Other | Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures. |
|
Satisfaction with the given information will be measured using 8 items with three points scale. |
| 7-10 days |
| Number of Click on the Homepage | Number of click on the Homepage will be assessed trough Pickwick software. | Through study completion, an average of 10 days |
| Number of Times Web Platforms Were Accessed | Number of Times Web Platforms were Accessed assessed trough Pickwick software | Through study completion, an average of 10 days |
| Number of Pages Visited on the Web Platforms | Number of Pages Visited on the Web Platforms on the web decision aid assessed trough Pickwick software. | Through study completion, an average of 10 days |
| Number of Participants With Decisional Conflict Using Decisional Conflict Scale-SURE Version | Decisional conflict will be assessed using the validated and widely used Decisional Conflict Scale-SURE version, consisted in four-item scale. | 7-10 days |
| Milan |
| 20122 |
| Italy |
| IRCCS-Istituto di Ricerche Farmacologiche Mario Negri | Milan | 20156 | Italy |
| U.O. Centro Gestionale Screening, Azienda Sanitaria Provinciale di Palermo | Palermo | Italy |
| Centro Screeening - AUSL Reggio Emilia | Reggio Emilia | 42122 | Italy |
| CPO Piemonte | Torino | Italy |
| SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza | Torino | Italy |
| Roberto A, Colombo C, Candiani G, Satolli R, Giordano L, Jaramillo L, Castagno R, Mantellini P, Falini P, Carnesciali E, Valenza M, Costa L, Campari C, Caroli S, Faggiano RC, Orione L, Belmessieri B, Marchio V, Deandrea S, Silvestri A, Luciano D, Paci E, Mosconi P. A dynamic web-based decision aid to improve informed choice in organised breast cancer screening. A pragmatic randomised trial in Italy. Br J Cancer. 2020 Sep;123(5):714-721. doi: 10.1038/s41416-020-0935-2. Epub 2020 Jun 17. |
| BG001 | Standard Information | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Marital status | Number | participants |
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| Education | Number | participants |
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| Employment status | Number | participants |
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| OG001 | Standard Information | 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. |
|
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| Primary | Attitude | 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. | Positive attitude | Posted | Number | participants | 7-10 days |
|
|
|
| Primary | Intention | 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. | Positive intention | Posted | Number | participants | 7-10 days |
|
|
|
| Secondary | Participation Rate to the Breast Cancer Screening Programme | 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. | Participants who had already had a mammogram in the past 6 months were excluded from this dataset. | Posted | Number | percentage of participants | 15-60 days |
|
|
|
| Secondary | Satisfaction With the Information Measured Using 8 Items With Three Points Scale | Satisfaction with the given information will be measured using 8 items with three points scale. | 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 | Posted | Number | participants | 7-10 days |
|
|
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| Secondary | Number of Click on the Homepage | Number of click on the Homepage will be assessed trough Pickwick software. | Posted | Number | clicks | Through study completion, an average of 10 days |
|
|
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| Secondary | Number of Times Web Platforms Were Accessed | Number of Times Web Platforms were Accessed assessed trough Pickwick software | Posted | Mean | Standard Deviation | number of access | Through study completion, an average of 10 days |
|
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| Secondary | Number of Pages Visited on the Web Platforms | Number of Pages Visited on the Web Platforms on the web decision aid assessed trough Pickwick software. | 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. | Posted | Mean | Standard Deviation | Number of pages | Through study completion, an average of 10 days |
|
|
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| Secondary | Number of Participants With Decisional Conflict Using Decisional Conflict Scale-SURE Version | Decisional conflict will be assessed using the validated and widely used Decisional Conflict Scale-SURE version, consisted in four-item scale. | Posted | Number | participants | 7-10 days |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard Information | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| Fair |
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| Missing |
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