Trial Outcomes & Findings for Decision-aid on Breast Cancer Screening (NCT NCT03097653)
NCT ID: NCT03097653
Last Updated: 2021-03-24
Results Overview
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".
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1001 participants
Primary outcome timeframe
7-10 days
Results posted on
2021-03-24
Participant Flow
Date of first enrollment: September 2017 Date of last invitation: 31 December 2018 End of study: April 2019
Participant milestones
| Measure |
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.
|
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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|---|---|---|
|
Overall Study
STARTED
|
472
|
529
|
|
Overall Study
COMPLETED
|
472
|
529
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Decision-aid on Breast Cancer Screening
Baseline characteristics by cohort
| Measure |
Decision-aid
n=472 Participants
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
n=529 Participants
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.
|
Total
n=1001 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
49.0 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
49.2 years
STANDARD_DEVIATION 3.3 • n=7 Participants
|
49.1 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
472 Participants
n=5 Participants
|
529 Participants
n=7 Participants
|
1001 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Italian
|
458 participants
n=5 Participants
|
506 participants
n=7 Participants
|
964 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
12 participants
n=5 Participants
|
20 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Marital status
Unmarried
|
60 participants
n=5 Participants
|
61 participants
n=7 Participants
|
121 participants
n=5 Participants
|
|
Marital status
Married or cohabitant
|
342 participants
n=5 Participants
|
386 participants
n=7 Participants
|
728 participants
n=5 Participants
|
|
Marital status
Separated or divorced
|
62 participants
n=5 Participants
|
73 participants
n=7 Participants
|
135 participants
n=5 Participants
|
|
Marital status
Widowed
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Marital status
Missing
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Education
Elementary
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Education
Lower middle
|
69 participants
n=5 Participants
|
71 participants
n=7 Participants
|
140 participants
n=5 Participants
|
|
Education
Higher middle
|
234 participants
n=5 Participants
|
272 participants
n=7 Participants
|
506 participants
n=5 Participants
|
|
Education
Degree
|
156 participants
n=5 Participants
|
170 participants
n=7 Participants
|
326 participants
n=5 Participants
|
|
Education
Other
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Education
Missing
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Employment status
Paid work
|
366 participants
n=5 Participants
|
425 participants
n=7 Participants
|
791 participants
n=5 Participants
|
|
Employment status
No paid work
|
104 participants
n=5 Participants
|
101 participants
n=7 Participants
|
205 participants
n=5 Participants
|
|
Employment status
Missing
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7-10 daysKnowledge 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".
Outcome measures
| Measure |
Decision-aid
n=472 Participants
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
n=529 Participants
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.
|
|---|---|---|
|
Number of Participants With Adequate Knowledge
|
236 participants
|
218 participants
|
PRIMARY outcome
Timeframe: 7-10 daysPopulation: Positive 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.
Outcome measures
| Measure |
Decision-aid
n=472 Participants
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
n=529 Participants
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.
|
|---|---|---|
|
Attitude
|
432 participants
|
489 participants
|
PRIMARY outcome
Timeframe: 7-10 daysPopulation: Positive 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.
Outcome measures
| Measure |
Decision-aid
n=472 Participants
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
n=529 Participants
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.
|
|---|---|---|
|
Intention
|
460 participants
|
500 participants
|
SECONDARY outcome
Timeframe: 15-60 daysPopulation: 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 will be assessed as a percentage of participants who actually participate, both in intervention and in the control group.
Outcome measures
| Measure |
Decision-aid
n=447 Participants
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
n=501 Participants
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.
|
|---|---|---|
|
Participation Rate to the Breast Cancer Screening Programme
|
84.1 percentage of participants
|
83.0 percentage of participants
|
SECONDARY outcome
Timeframe: 7-10 daysPopulation: 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 given information will be measured using 8 items with three points scale.
Outcome measures
| Measure |
Decision-aid
n=472 Participants
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
n=529 Participants
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.
|
|---|---|---|
|
Satisfaction With the Information Measured Using 8 Items With Three Points Scale
Too much
|
17 participants
|
6 participants
|
|
Satisfaction With the Information Measured Using 8 Items With Three Points Scale
Too little
|
19 participants
|
31 participants
|
|
Satisfaction With the Information Measured Using 8 Items With Three Points Scale
Fair
|
432 participants
|
480 participants
|
|
Satisfaction With the Information Measured Using 8 Items With Three Points Scale
Missing
|
4 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 10 daysNumber of click on the Homepage will be assessed trough Pickwick software.
Outcome measures
| Measure |
Decision-aid
n=472 Participants
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
n=529 Participants
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.
|
|---|---|---|
|
Number of Click on the Homepage
|
514 clicks
|
334 clicks
|
SECONDARY outcome
Timeframe: Through study completion, an average of 10 daysNumber of Times Web Platforms were Accessed assessed trough Pickwick software
Outcome measures
| Measure |
Decision-aid
n=472 Participants
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
n=529 Participants
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.
|
|---|---|---|
|
Number of Times Web Platforms Were Accessed
|
1.1 number of access
Standard Deviation 0.3
|
1.0 number of access
Standard Deviation 0.1
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SECONDARY outcome
Timeframe: Through study completion, an average of 10 daysPopulation: 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.
Number of Pages Visited on the Web Platforms on the web decision aid assessed trough Pickwick software.
Outcome measures
| Measure |
Decision-aid
n=472 Participants
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
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.
|
|---|---|---|
|
Number of Pages Visited on the Web Platforms
|
4.8 Number of pages
Standard Deviation 4.2
|
—
|
SECONDARY outcome
Timeframe: 7-10 daysDecisional conflict will be assessed using the validated and widely used Decisional Conflict Scale-SURE version, consisted in four-item scale.
Outcome measures
| Measure |
Decision-aid
n=472 Participants
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
n=529 Participants
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.
|
|---|---|---|
|
Number of Participants With Decisional Conflict Using Decisional Conflict Scale-SURE Version
Decisional conflict (score ≥3)
|
68 participants
|
102 participants
|
|
Number of Participants With Decisional Conflict Using Decisional Conflict Scale-SURE Version
No decisional conflict
|
404 participants
|
427 participants
|
Adverse Events
Decision-aid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Information
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Paola Mosconi and Dr. Anna Roberto
Istituto di Ricerche Farmacologiche Mario Negri IRCCS
Phone: +390239014503
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place