Assessment of Feasibility and Acceptability of Personalized Breast Cancer Screening

Study Overview
=================
Brief Summary
-----------------
The overall objective is to assess the acceptability and feasibility of offering personalized breast cancer (BC) screening. The specific objectives are: 1) To design an information system; 2) To evaluate the barriers and facilitators of the coordination of health care services and the screening program; 3) To develop a proof of concept of personalized screening; and 4) To evaluate cost-effectiveness. Methodology: Prototype information system with basal and longitudinal variables relevant to a personalized screening system; Qualitative study with focus groups and survey. The attitude and acceptability on a sample of 210 health professionals will be assessed; Prospective observational study, for proof of concept. Participants will be professionals working in Primary Care, Population Breast Screening Program, or Hospital Breast Unit. It will include 385 women, aged 40-50 from the city of Lleida. Various indicators of acceptability and feasibility will be assessed in women and health professionals; Probabilistic analytical models will be used to evaluate cost-effectiveness. The present protocol addresses the specific objective number 3, the proof of concept of personalised screening. Expected results: The investigators expect to provide valuable and necessary information for the design of personalized screening.

Official Title
-----------------
Personalized Breast Cancer Screening: Assessment of Its Feasibility and Acceptability in the National Health System

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: Risk based screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not having had a mammogram in the last 12 months or with a mammogram in this period available to evaluate breast density. Sign the informed consent. Exclusion Criteria: Previous diagnosis of breast cancer. Breast study in process. Fulfill clinical criteria defined by the Medical Oncology Spanish Society (SEOM to refer to the genetic counseling unit in cancer. Do not understand or speak Catalan or Spanish. Cognitive disability for mental or mental illness. Physical disability that prevents a mammogram.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Risk based screening|Breast cancer risk measurement, screening recommendations and shared decision making|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attitude towards personalised breast cancer screening (by participant women) | Attitude scale with three items, one about the frequency of screening exams (ranges from 1 to 5). The other two items ask if participants are satisfied of being invited more/less frequently, in case that they have a higher/lower risk of breast cancer than the average women. They also range from 1 to 5. Total scores can range from 3 to 15. Higher scores indicate more positive attitudes. A positive attitude is defined as a total score greater or equal to 12. Adapted from Hersch et al. (2015) | 2-4 weeks after being informed of the individual breast cancer risk | 
| Intention to participate in personalised breast cancer screening | Categorical variable with five categories: definitely will, likely to, unsure, not likely to, definitely will not. The absolute and relative frequencies of the five categories will be obtained. In addition, the variable will be dichotomized as intending to participate (definitely or likely) or not. Adapted from Hersch et al. (2015) | 2-4 weeks after being informed of the individual breast cancer risk | 
| Satisfaction with personalised screening | Satisfaction Likert scale with one item that ranges from 1 to 5: not at all satisfied (1), extremely satisfied (5). Following the Sekhon et al. review (2017) | At 1 year of the study start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening attitudes scale | General attitudes scale towards screening mammography. It will be measured using five items adapted from Hersch et al. (2015). Each item ranges from 1 to 5. Total scores can range from 5 to 25. A positive attitude is defined as a total score greater or equal to 20. Higher scores indicate more positive attitudes. Adapted from Hersch et al. (2015) | 2-4 weeks after being informed of the individual breast cancer risk | 
| Attitude towards the measure of breast cancer risk | One categorical variable with four categories. It asks if the measure of breast cancer risk will do more harm than good, more good than harm, it depends, do not know. The absolute and relative frequencies of the four categories will be obtained. Following the Sekhon et al. review (2017) | 2-4 weeks after being informed of the individual breast cancer risk | 
| Emotional impact of the measure of breast cancer risk | Three categorical variables with five categories, ranging from strongly disagree (1) to strongly agree (5). First variable: The information about the individual risk of breast cancer provides calmness. Second variable: Receiving information about risks produces anxiety. Third variable: The information about the individual risk of breast cancer makes me worry. The scores of the three items will not be added as a scale, they will be reported separately. Adapted from Hersch et al. (2015) | 2-4 weeks after being informed of the individual breast cancer risk | 
| Preference with regard to the current screening, biennial between 50 and 69 years | Categorical variable with three categories. It asks what type of screening the participants would choose (personalized risk-based or one-size-fits-all) | 2-4 weeks after being informed of the individual breast cancer risk | 
| Knowledge of the benefits and harms of breast cancer screening | Eleven conceptual knowledge questions (Yes/No) and four numerical knowledge questions with categories on the effect of screening. A total of 22 marks could be obtained, 11 coming from the questions on conceptual knowledge and 11 coming from the questions on numerical knowledge that measured absolute and relative values of the screening outcomes. The threshold to define adequate knowledge is to score at least 50% of the available marks, including at least one numerical mark, on all the three screening outcome subscales that refer to mortality reduction, overdiagnosis, and false positives. Adapted from Hersch et al. (2015) | 2-4 weeks after being informed of the individual breast cancer risk | 
| Decisional conflict | O'Connor Decisional Conflict Scale, 10-item low literacy version, on a scale from 0 (no decisional conflict) to 100 (extreme decisional conflict). Scores less than 25 are associated with implementing decisions; score exceeding 37.5 are associated with decision delay or feeling unsure about implementation. | 2-4 weeks after being informed of the individual breast cancer risk | 
| Confidence in the decision | Three Likert scale statements rated from 1 (not at all confident) to 5 (very confident). A total score is obtained summing the scores of the three items and dividing by three. Adapted from the O'Connor Decision Self-Efficacy Scale | 2-4 weeks after being informed of the individual breast cancer risk | 
| Anxiety about screening participation | Six-item short form of the Spielberger State Trait Anxiety Inventory (STAI) on a scale from 20 to 80, with higher scores indicating greater levels of anxiety. To calculate the total STAI score, reverse scoring of the positive items (calm, relaxed, content), sum all six scores and multiply total score by 20/6. | 2-4 weeks after being informed of the individual breast cancer risk | 
| Perceived significance of the benefits and the adverse effects of screening | Women will be asked how important it is for them to consider the chances of (1) avoiding breast cancer death, (2) being diagnosed and treated for a cancer that is not harmful, and (3) having a false positive. The four response options range from very important (1) to not at all important (4). The scores of the three items will not be added as a scale, they will be reported separately. According to Hersch et al. (2015) | 2-4 weeks after being informed of the individual breast cancer risk | 
| Self-efficacy | Four items ranging from strongly disagree (1) to strongly agree (5). Total scores can range from 4 to 20. Higher scores indicate higher self-efficacy. Following the Sekhon et al. review (2017) | 2-4 weeks after being informed of the individual breast cancer risk | 
| Experience assessment | It will be measured using five items. Each item ranges from 1 to 5. Total scores can range from 5 to 25. A positive assessment is defined as a total score greater or equal to 20. Higher scores indicate more positive experience assessment. Following the Sekhon et al. review (2017) | 2-4 weeks after being informed of the individual breast cancer risk | 
| Confidence in personalised screening | Confidence Likert scale with one item ranging from very low confidence (1) to very high confidence (5) . Following the Sekhon et al. review (2017) | 2-4 weeks after being informed of the individual breast cancer risk | 
| Understanding of the individual risk and the screening recommendations | Two categorical variables with five categories each, ranging from strongly disagree (1) to strongly agree (5). First variable: I understood the information I received about my risk of breast cancer in relation to women of my age. Second variable: I have understood the recommendations given to me about the screening of breast cancer in the coming years, based on my risk of breast cancer. The scores of the two items will not be added as a scale, they will be reported separately. Following the Sekhon et al. review (2017) | 2-4 weeks after being informed of the individual breast cancer risk | 
| Time spent on risk communication | Continuous variable, number of minutes. Recorded by the participant doctors | At the time of communicating risk, 2-4 weeks after the baseline visit | 
| Proportion of women who accept to participate in the study | Number of women that accept to participate divided by number of women contacted | Through study completion, an average of 1.75 years | 
| Proportion of participating women who complete the different phases of the study | Number of women that complete the different phases divided by number of participating women | Through study completion, an average of 1.75 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Personalized, Early detection, Screening, Feasibility, Acceptability