NCT03097653

Decision-aid on Breast Cancer Screening

Completed NA Results posted Last updated 24 March 2021

What this trial tests

NA trial testing Decision-aid in Breast Cancer in 1,001 participants. Completed in 30 April 2019.

Timeline

1 September 2017

Primary endpoint
20 April 2019

30 April 2019

Quick facts

Lead sponsor	Mario Negri Institute for Pharmacological Research
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	1,001
Start date	1 September 2017
Primary completion	20 April 2019
Estimated completion	30 April 2019
Sites	7 locations across Italy

Drugs / interventions tested

• Decision-aid
• Standard information

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Mario Negri Institute for Pharmacological Research

Who can join

Adults 45 to 69, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adequate Knowledge Primary · 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".

Group	Value	95% CI
Decision-aid	236
Standard Information	218

Attitude Primary · 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.

Group	Value	95% CI
Decision-aid	432
Standard Information	489

Intention Primary · 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.

Group	Value	95% CI
Decision-aid	460
Standard Information	500

Participation Rate to the Breast Cancer Screening Programme Secondary · 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.

Group	Value	95% CI
Decision-aid	84.1
Standard Information	83.0

Satisfaction With the Information Measured Using 8 Items With Three Points Scale Secondary · 7-10 days

Satisfaction with the given information will be measured using 8 items with three points scale.

Too much

Group	Value	95% CI
Decision-aid	17
Standard Information	6

Too little

Group	Value	95% CI
Decision-aid	19
Standard Information	31

Fair

Group	Value	95% CI
Decision-aid	432
Standard Information	480

Missing

Group	Value	95% CI
Decision-aid	4
Standard Information	12

Number of Click on the Homepage Secondary · Through study completion, an average of 10 days

Number of click on the Homepage will be assessed trough Pickwick software.

Group	Value	95% CI
Decision-aid	514
Standard Information	334

Number of Times Web Platforms Were Accessed Secondary · Through study completion, an average of 10 days

Number of Times Web Platforms were Accessed assessed trough Pickwick software

Group	Value	95% CI
Decision-aid	1.1	± 0.3
Standard Information	1.0	± 0.1

Number of Pages Visited on the Web Platforms Secondary · 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.

Group	Value	95% CI
Decision-aid	4.8	± 4.2

Number of Participants With Decisional Conflict Using Decisional Conflict Scale-SURE Version Secondary · 7-10 days

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

Decisional conflict (score ≥3)

Group	Value	95% CI
Decision-aid	68
Standard Information	102

No decisional conflict

Group	Value	95% CI
Decision-aid	404
Standard Information	427

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Decision aids for people facing health treatment or screening decisions.
   Stacey D, Lewis KB, Smith M, Carley M, et al · · 2024 · cited 203× · PMID 38284415 · DOI 10.1002/14651858.cd001431.pub6
2. A dynamic web-based decision aid to improve informed choice in organised breast cancer screening. A pragmatic randomised trial in Italy.
   Roberto A, Colombo C, Candiani G, Satolli R, et al · · 2020 · cited 23× · PMID 32546834 · DOI 10.1038/s41416-020-0935-2
3. Personalised informed choice on evidence and controversy on mammography screening: study protocol for a randomized controlled trial.
   Roberto A, Colombo C, Candiani G, Giordano L, et al · · 2017 · cited 10× · PMID 28629329 · DOI 10.1186/s12885-017-3428-9