Decision-aid on Breast Cancer Screening
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03097653|
Recruitment Status : Completed
First Posted : March 31, 2017
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: Decision-aid Other: Standard information||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||816 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||New Invited Women to Breast Cancer Screening: a Multi-centre, Longitudinal, Controlled, Randomised Study on a Decision-aid to Support Informed Choice|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||April 20, 2019|
|Actual Study Completion Date :||April 30, 2019|
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.
|Active Comparator: Standard information||
Other: Standard information
Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.
- Knowledge measured using a questionnaire [ 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".
- Attitude measured through a scale [ 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.
- Intention measured using 1 item with 5 responses [ 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.
- 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 women who actually participate, both in intervention and in the control group.
- 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.
- Number of pages visited [ Time Frame: Through study completion, an average of 10 days ]Number of pages visited on the web decision aid will be assessed trough Pickwick software.
- frequency of access on the web platforms [ Time Frame: Through study completion, an average of 10 days ]The frequency of access on the web decision aid will be assessed trough Pickwick software
- Level of detail reached on the web platforms [ Time Frame: Through study completion, an average of 10 days ]Level of detail reached on the web platforms on the web decision aid will be assessed trough Pickwick software.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097653
|Screening Unit, Cancer Prevention and Research Institute - ISPO|
|UOC Medicina Preventiva delle Comunità - Screening|
|Milan, Italy, 20122|
|IRCCS-Istituto di Ricerche Farmacologiche Mario Negri|
|Milan, Italy, 20156|
|U.O. Centro Gestionale Screening, Azienda Sanitaria Provinciale di Palermo|
|Centro Screeening - AUSL Reggio Emilia|
|Reggio Emilia, Italy, 42122|
|SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza|