Decision-aid on Breast Cancer Screening

NCT03097653 | Completed Results

• 1 other identifier: IRFMN-AIRC-6901
• Study Type: interventional
• Target: 1,001
• Locations: 1 country
• Sites: 7

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.

Conditions

Breast Cancer

Keywords

breast cancer screening; mammography; decision-aid; informed choice; National Cancer Screening Program

Outcome Measures

Primary Outcomes (3)

• 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".

  7-10 days

• 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.

  7-10 days

• 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.

  7-10 days

Secondary Outcomes (6)

• Participation Rate to the Breast Cancer Screening Programme

  15-60 days

• Satisfaction With the Information Measured Using 8 Items With Three Points Scale

  7-10 days

• Number of Click on the Homepage

  Through study completion, an average of 10 days

• Number of Times Web Platforms Were Accessed

  Through study completion, an average of 10 days

• Number of Pages Visited on the Web Platforms

  Through study completion, an average of 10 days

Study Arms (2)

Decision-aid

EXPERIMENTAL

Other: Decision-aid

Standard information

ACTIVE COMPARATOR

Other: Standard information

Interventions

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.

Decision-aid

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.

Standard information

Eligibility Criteria

• Age: 45 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 45-69, according to the target age of the screening centres involved;
• New invited women in mammography screening programme.

You may not qualify if:

• None

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (7)

Screening Unit, Cancer Prevention and Research Institute - ISPO

Florence, Italy

Location

UOC Medicina Preventiva delle Comunità - Screening

Milan, 20122, Italy

Location

IRCCS-Istituto di Ricerche Farmacologiche Mario Negri

Milan, 20156, Italy

Location

U.O. Centro Gestionale Screening, Azienda Sanitaria Provinciale di Palermo

Palermo, Italy

Location

Centro Screeening - AUSL Reggio Emilia

Reggio Emilia, 42122, Italy

Location

CPO Piemonte

Torino, Italy

Location

SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza

Torino, Italy

Location

Related Publications (2)

• 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.

  PMID: 28629329 BACKGROUND

• Roberto A, Colombo C, Candiani G, Satolli R, Giordano L, Jaramillo L, Castagno R, Mantellini P, Falini P, Carnesciali E, Valenza M, Costa L, Campari C, Caroli S, Faggiano RC, Orione L, Belmessieri B, Marchio V, Deandrea S, Silvestri A, Luciano D, Paci E, Mosconi P. A dynamic web-based decision aid to improve informed choice in organised breast cancer screening. A pragmatic randomised trial in Italy. Br J Cancer. 2020 Sep;123(5):714-721. doi: 10.1038/s41416-020-0935-2. Epub 2020 Jun 17.

  PMID: 32546834 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and 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

Results Point of Contact

• Title: Dr. Paola Mosconi and Dr. Anna Roberto
• Organization: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

donnainformata-mammografia@marionegri.it; paola.mosconi@marionegri.it

+390239014503

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 31, 2017
• Study Start: September 1, 2017
• Primary Completion: April 20, 2019
• Study Completion: April 30, 2019
• Last Updated: March 24, 2021
• Results First Posted: March 24, 2021

Record last verified: 2021-03

Locations

IT (7)