Decision-aid on Breast Cancer Screening

• Sponsor: Mario Negri Institute for Pharmacological Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT03097653
• Collaborator: (none)
• Enrollment: 1,001
• Locations: 7
• Arms: 2
• Actual Duration (Months): 19.9
• Patients Per Site: 143
• Patients Per Site Per Month: 7.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Decision-aid; Other: Standard information	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1001 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: New Invited Women to Breast Cancer Screening: a Multi-centre, Longitudinal, Controlled, Randomised Study on a Decision-aid to Support Informed Choice
• Actual Study Start Date: Sep 1, 2017
• Actual Primary Completion Date: Apr 20, 2019
• Actual Study Completion Date: Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Decision-aid	Other: 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.
Active Comparator: Standard information	Other: 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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adequate Knowledge [7-10 days]

   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".

2. Attitude [7-10 days]

   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.

3. Intention [7-10 days]

   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.

Secondary Outcome Measures

1. Participation Rate to the Breast Cancer Screening Programme [15-60 days]

   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.

2. Satisfaction With the Information Measured Using 8 Items With Three Points Scale [7-10 days]

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

3. Number of Click on the Homepage [Through study completion, an average of 10 days]

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

4. Number of Times Web Platforms Were Accessed [Through study completion, an average of 10 days]

   Number of Times Web Platforms were Accessed assessed trough Pickwick software

5. Number of Pages Visited on the Web Platforms [Through study completion, an average of 10 days]

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

6. Number of Participants With Decisional Conflict Using Decisional Conflict Scale-SURE Version [7-10 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 69 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Women aged 45-69, according to the target age of the screening centres involved;

• New invited women in mammography screening programme.

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Screening Unit, Cancer Prevention and Research Institute - ISPO	Firenze		Italy
2	UOC Medicina Preventiva delle Comunità - Screening	Milan		Italy	20122
3	IRCCS-Istituto di Ricerche Farmacologiche Mario Negri	Milan		Italy	20156
4	U.O. Centro Gestionale Screening, Azienda Sanitaria Provinciale di Palermo	Palermo		Italy
5	Centro Screeening - AUSL Reggio Emilia	Reggio Emilia		Italy	42122
6	CPO Piemonte	Torino		Italy
7	SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza	Torino		Italy

Sponsors and Collaborators

• Mario Negri Institute for Pharmacological Research

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 1, 2018

More Information

Publications

• 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.

• Responsible Party: Mario Negri Institute for Pharmacological Research
• ClinicalTrials.gov Identifier: NCT03097653
• Other Study ID Numbers: IRFMN-AIRC-6901
• First Posted: Mar 31, 2017
• Last Update Posted: Mar 24, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mario Negri Institute for Pharmacological Research: breast cancer screening; mammography; decision-aid; informed choice; National Cancer Screening Program
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

Participant Flow

Recruitment Details	Date of first enrollment: September 2017 Date of last invitation: 31 December 2018 End of study: April 2019

Arm/Group Title	Decision-aid	Standard Information
Arm/Group Description	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.
Period Title: Overall Study
STARTED	472	529
COMPLETED	472	529
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Decision-aid	Standard Information	Total
Arm/Group Description	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.	Total of all reporting groups
Overall Participants	472	529	1001
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.0 (3.0)	49.2 (3.3)	49.1 (3.2)
Sex: Female, Male (Count of Participants)
Female	472 100%	529 100%	1001 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
Italian	458 97%	506 95.7%	964 96.3%
Other	12 2.5%	20 3.8%	32 3.2%
Missing	2 0.4%	3 0.6%	5 0.5%
Marital status (participants) [Number]
Unmarried	60 12.7%	61 11.5%	121 12.1%
Married or cohabitant	342 72.5%	386 73%	728 72.7%
Separated or divorced	62 13.1%	73 13.8%	135 13.5%
Widowed	6 1.3%	6 1.1%	12 1.2%
Missing	2 0.4%	3 0.6%	5 0.5%
Education (participants) [Number]
Elementary	2 0.4%	4 0.8%	6 0.6%
Lower middle	69 14.6%	71 13.4%	140 14%
Higher middle	234 49.6%	272 51.4%	506 50.5%
Degree	156 33.1%	170 32.1%	326 32.6%
Other	9 1.9%	9 1.7%	18 1.8%
Missing	2 0.4%	3 0.6%	5 0.5%
Employment status (participants) [Number]
Paid work	366 77.5%	425 80.3%	791 79%
No paid work	104 22%	101 19.1%	205 20.5%
Missing	2 0.4%	3 0.6%	5 0.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adequate Knowledge
Description	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".
Time Frame	7-10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Decision-aid	Standard Information
Arm/Group Description	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.
Measure Participants	472	529
Number [participants]	236 50%	218 41.2%

2. Primary Outcome

Title	Attitude
Description	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.
Time Frame	7-10 days

Outcome Measure Data

Analysis Population Description

Positive attitude

Arm/Group Title	Decision-aid	Standard Information
Arm/Group Description	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.
Measure Participants	472	529
Number [participants]	432 91.5%	489 92.4%

3. Primary Outcome

Title	Intention
Description	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.
Time Frame	7-10 days

Outcome Measure Data

Analysis Population Description

Positive intention

Arm/Group Title	Decision-aid	Standard Information
Arm/Group Description	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.
Measure Participants	472	529
Number [participants]	460 97.5%	500 94.5%

4. Secondary Outcome

Title	Participation Rate to the Breast Cancer Screening Programme
Description	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.
Time Frame	15-60 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Decision-aid	Standard Information
Arm/Group Description	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.
Measure Participants	447	501
Number [percentage of participants]	84.1 17.8%	83.0 15.7%

5. Secondary Outcome

Title	Satisfaction With the Information Measured Using 8 Items With Three Points Scale
Description	Satisfaction with the given information will be measured using 8 items with three points scale.
Time Frame	7-10 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Decision-aid	Standard Information
Arm/Group Description	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.
Measure Participants	472	529
Too much	17 3.6%	6 1.1%
Too little	19 4%	31 5.9%
Fair	432 91.5%	480 90.7%
Missing	4 0.8%	12 2.3%

6. Secondary Outcome

Title	Number of Click on the Homepage
Description	Number of click on the Homepage will be assessed trough Pickwick software.
Time Frame	Through study completion, an average of 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Decision-aid	Standard Information
Arm/Group Description	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.
Measure Participants	472	529
Number [clicks]	514	334

7. Secondary Outcome

Title	Number of Times Web Platforms Were Accessed
Description	Number of Times Web Platforms were Accessed assessed trough Pickwick software
Time Frame	Through study completion, an average of 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Decision-aid	Standard Information
Arm/Group Description	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.
Measure Participants	472	529
Mean (Standard Deviation) [number of access]	1.1 (0.3)	1.0 (0.1)

8. Secondary Outcome

Title	Number of Pages Visited on the Web Platforms
Description	Number of Pages Visited on the Web Platforms on the web decision aid assessed trough Pickwick software.
Time Frame	Through study completion, an average of 10 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Decision-aid
Arm/Group Description	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.
Measure Participants	472
Mean (Standard Deviation) [Number of pages]	4.8 (4.2)

9. Secondary Outcome

Title	Number of Participants With Decisional Conflict Using Decisional Conflict Scale-SURE Version
Description	Decisional conflict will be assessed using the validated and widely used Decisional Conflict Scale-SURE version, consisted in four-item scale.
Time Frame	7-10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Decision-aid	Standard Information
Arm/Group Description	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.
Measure Participants	472	529
Decisional conflict (score ≥3)	68 14.4%	102 19.3%
No decisional conflict	404 85.6%	427 80.7%

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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. .
Arm/Group Title	Decision-aid		Standard Information
Arm/Group Description	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.
All Cause Mortality
	Decision-aid		Standard Information
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Decision-aid		Standard Information
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Decision-aid		Standard Information
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.