Breast Cancer
Conditions
Keywords
breast cancer screening, mammography, decision-aid, informed choice, National Cancer Screening Program
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.
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.
Interventions
OTHERDecision-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.
OTHERStandard information
Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.
Sponsors
Mario Negri Institute for Pharmacological Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 69 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Italy
Participant flow
Recruitment details
Date of first enrollment: September 2017 Date of last invitation: 31 December 2018 End of study: April 2019
Participants by arm
| Arm | Count |
|---|---|
| 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. | 472 |
| 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. | 529 |
| Total | 1,001 |
Baseline characteristics
| Characteristic | Decision-aid | Standard Information | Total |
|---|---|---|---|
| Age, Continuous | 49.0 years STANDARD_DEVIATION 3 | 49.2 years STANDARD_DEVIATION 3.3 | 49.1 years STANDARD_DEVIATION 3.2 |
| Education Degree | 156 participants | 170 participants | 326 participants |
| Education Elementary | 2 participants | 4 participants | 6 participants |
| Education Higher middle | 234 participants | 272 participants | 506 participants |
| Education Lower middle | 69 participants | 71 participants | 140 participants |
| Education Missing | 2 participants | 3 participants | 5 participants |
| Education Other | 9 participants | 9 participants | 18 participants |
| Employment status Missing | 2 participants | 3 participants | 5 participants |
| Employment status No paid work | 104 participants | 101 participants | 205 participants |
| Employment status Paid work | 366 participants | 425 participants | 791 participants |
| Marital status Married or cohabitant | 342 participants | 386 participants | 728 participants |
| Marital status Missing | 2 participants | 3 participants | 5 participants |
| Marital status Separated or divorced | 62 participants | 73 participants | 135 participants |
| Marital status Unmarried | 60 participants | 61 participants | 121 participants |
| Marital status Widowed | 6 participants | 6 participants | 12 participants |
| Race/Ethnicity, Customized Italian | 458 participants | 506 participants | 964 participants |
| Race/Ethnicity, Customized Missing | 2 participants | 3 participants | 5 participants |
| Race/Ethnicity, Customized Other | 12 participants | 20 participants | 32 participants |
| Sex: Female, Male Female | 472 Participants | 529 Participants | 1001 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 7-10 days
Population: Positive attitude
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decision-aid | Attitude | 432 participants |
| Standard Information | Attitude | 489 participants |
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.
Time frame: 7-10 days
Population: Positive intention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decision-aid | Intention | 460 participants |
| Standard Information | Intention | 500 participants |
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.
Time frame: 7-10 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decision-aid | Number of Participants With Adequate Knowledge | 236 participants |
| Standard Information | Number of Participants With Adequate Knowledge | 218 participants |
Secondary
Number of Click on the Homepage
Number of click on the Homepage will be assessed trough Pickwick software.
Time frame: Through study completion, an average of 10 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decision-aid | Number of Click on the Homepage | 514 clicks |
| Standard Information | Number of Click on the Homepage | 334 clicks |
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.
Time frame: Through study completion, an average of 10 days
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision-aid | Number of Pages Visited on the Web Platforms | 4.8 Number of pages | Standard Deviation 4.2 |
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.
Time frame: 7-10 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Decision-aid | Number of Participants With Decisional Conflict Using Decisional Conflict Scale-SURE Version | Decisional conflict (score ≥3) | 68 participants |
| Decision-aid | Number of Participants With Decisional Conflict Using Decisional Conflict Scale-SURE Version | No decisional conflict | 404 participants |
| Standard Information | Number of Participants With Decisional Conflict Using Decisional Conflict Scale-SURE Version | Decisional conflict (score ≥3) | 102 participants |
| Standard Information | Number of Participants With Decisional Conflict Using Decisional Conflict Scale-SURE Version | No decisional conflict | 427 participants |
Secondary
Number of Times Web Platforms Were Accessed
Number of Times Web Platforms were Accessed assessed trough Pickwick software
Time frame: Through study completion, an average of 10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision-aid | Number of Times Web Platforms Were Accessed | 1.1 number of access | Standard Deviation 0.3 |
| Standard Information | Number of Times Web Platforms Were Accessed | 1.0 number of access | Standard Deviation 0.1 |
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.
Time frame: 15-60 days
Population: Participants who had already had a mammogram in the past 6 months were excluded from this dataset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Decision-aid | Participation Rate to the Breast Cancer Screening Programme | 84.1 percentage of participants |
| Standard Information | Participation Rate to the Breast Cancer Screening Programme | 83.0 percentage of participants |
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.
Time frame: 7-10 days
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Decision-aid | Satisfaction With the Information Measured Using 8 Items With Three Points Scale | Too much | 17 participants |
| Decision-aid | Satisfaction With the Information Measured Using 8 Items With Three Points Scale | Too little | 19 participants |
| Decision-aid | Satisfaction With the Information Measured Using 8 Items With Three Points Scale | Fair | 432 participants |
| Decision-aid | Satisfaction With the Information Measured Using 8 Items With Three Points Scale | Missing | 4 participants |
| Standard Information | Satisfaction With the Information Measured Using 8 Items With Three Points Scale | Missing | 12 participants |
| Standard Information | Satisfaction With the Information Measured Using 8 Items With Three Points Scale | Too much | 6 participants |
| Standard Information | Satisfaction With the Information Measured Using 8 Items With Three Points Scale | Fair | 480 participants |
| Standard Information | Satisfaction With the Information Measured Using 8 Items With Three Points Scale | Too little | 31 participants |