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AzTrials

Breast CancerDECIDONCT03791008

Assessment of Feasibility and Acceptability of Personalized Breast Cancer Screening

A study testing Risk based screening in people with Breast Cancer, run by Institut de Recerca Biomèdica de Lleida at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
Risk based screening
How many people
387 participants
Where
1 siteSpain
Study dates
30 Jan 2019to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Institut de Recerca Biomèdica de Lleida

    Lleida, 25198

Other trials in Spain

About this study

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

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.

Read more

Methodology:

  1. Prototype information system with basal and longitudinal variables relevant to a personalized screening system;
  2. Qualitative study with focus groups and survey. The attitude and acceptability on a sample of 210 health professionals will be assessed;
  3. 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;
  4. 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.

Conditions
Breast Cancer
Being tested
Risk based screening
Keywords
Personalized, Early detection, Screening, Feasibility, Acceptability
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Risk based screeningOther

    Breast cancer risk measurement, screening recommendations and shared decision making

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 2-4 weeks after being informed of the individual breast cancer risk

  2. 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)

    Measured: 2-4 weeks after being informed of the individual breast cancer risk

  3. 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)

    Measured: At 1 year of the study start

Secondary outcomes (16)

  1. 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)

    Measured: 2-4 weeks after being informed of the individual breast cancer risk

  2. 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)

    Measured: 2-4 weeks after being informed of the individual breast cancer risk

  3. 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)

    Measured: 2-4 weeks after being informed of the individual breast cancer risk

  4. 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")

    Measured: 2-4 weeks after being informed of the individual breast cancer risk

  5. 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)

    Measured: 2-4 weeks after being informed of the individual breast cancer risk

  6. 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.

    Measured: 2-4 weeks after being informed of the individual breast cancer risk

  7. 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

    Measured: 2-4 weeks after being informed of the individual breast cancer risk

  8. 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.

    Measured: 2-4 weeks after being informed of the individual breast cancer risk

  9. 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)

    Measured: 2-4 weeks after being informed of the individual breast cancer risk

  10. 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)

    Measured: 2-4 weeks after being informed of the individual breast cancer risk

  11. 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)

    Measured: 2-4 weeks after being informed of the individual breast cancer risk

  12. 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)

    Measured: 2-4 weeks after being informed of the individual breast cancer risk

  13. 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)

    Measured: 2-4 weeks after being informed of the individual breast cancer risk

  14. Time spent on risk communication

    Continuous variable, number of minutes. Recorded by the participant doctors

    Measured: At the time of communicating risk, 2-4 weeks after the baseline visit

  15. Proportion of women who accept to participate in the study

    Number of women that accept to participate divided by number of women contacted

    Measured: Through study completion, an average of 1.75 years

  16. 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

    Measured: Through study completion, an average of 1.75 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2019
  2. Study start30 Jan 2019
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
387 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03791008
Sponsor's protocol ID
PI17/00834
Acronym
DECIDO
Status last verified
Mar 2022
First submitted
16 Nov 2018
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hersch J, Barratt A, Jansen J, Irwig L, McGeechan K, Jacklyn G, Thornton H, Dhillon H, Houssami N, McCaffery K. Use of a decision aid including information on overdetection to support informed choice about breast cancer screening: a randomised controlled trial. Lancet. 2015 Apr 25;385(9978):1642-52. doi: 10.1016/S0140-6736(15)60123-4. Epub 2015 Feb 18.

    PubMed 25701273

  • Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.

    PubMed 28126032

  • Pons-Rodriguez A, Forne Izquierdo C, Vilaplana-Mayoral J, Cruz-Esteve I, Sanchez-Lopez I, Rene-Rene M, Cazorla C, Hernandez-Andreu M, Galindo-Ortego G, Llorens Gabande M, Laza-Vasquez C, Balaguer-Llaquet P, Martinez-Alonso M, Rue M; DECIDO Group. Feasibility and acceptability of personalised breast cancer screening (DECIDO study): protocol of a single-arm proof-of-concept trial. BMJ Open. 2020 Dec 23;10(12):e044597. doi: 10.1136/bmjopen-2020-044597.

    PubMed 33361170

Questions about this trial

What is this clinical trial studying?

A study testing Risk based screening in people with Breast Cancer, run by Institut de Recerca Biomèdica de Lleida at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Attitude towards personalised breast cancer screening (by participant women) (time frame: 2-4 weeks after being informed of the individual breast cancer risk). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03791008, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.

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