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Completed

NCT Number: NCT03097653

Decision-aid on Breast Cancer Screening

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.

Completed

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

45 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Screening Unit, Cancer Prevention and Research Institute - ISPO, Florence, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decision-aid

Other

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

Other

Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.

Primary outcomes

  1. Number of Participants With Adequate Knowledge

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Participation Rate to the Breast Cancer Screening Programme

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 7-10 days

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

Sponsors and collaborators

Lead sponsor

Mario Negri Institute for Pharmacological Research

Other

Registry information

Official study title

New Invited Women to Breast Cancer Screening: a Multi-centre, Longitudinal, Controlled, Randomised Study on a Decision-aid to Support Informed Choice

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 31, 2017
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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