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Spots Global Cancer Trial Database for Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making

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Trial Identification

Brief Title: Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making

Official Title: The Effect of Receiving Information About the Benefits and Harms of Mammography Screening on Women's Decision Making

Study ID: NCT03046004

Study Description

Brief Summary: The aim of this study is to assess the effect of receiving information about the benefits and harms of mammography screening on informed choice, decisional conflict, intention to participate in the Early Detection of Breast Cancer Program (EDBCP), and satisfaction. The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). The sample of participants is composed by 400 women from Catalonia and the Canary Islands (Spain) who will receive their first invitation to participate in the EDBCP of the Public Health Service in a period of 2-4 months.

Detailed Description: The selected women will receive a letter of invitation with information about the study. In the following 1-2 weeks they will receive a phone call to confirm that they have received the mailed letter and to assess the inclusion criteria. If they agree to participate in the study, they will be asked for informed consent. All the participants will receive a first questionnaire, the pre-intervention survey (10-15 minutes), via web or regular mail. Trained interviewers will collect the responses by phone for women who prefer this method. Once the pre-intervention survey is completed, women will receive the leaflet (intervention or control) via regular mail. Two weeks later, the participants will be contacted again to collect the post-intervention survey (15-20 minutes), via web or by phone. Participation in the mammographic exams of the EDBCP will be collected in the three-month period following the corresponding invitation letter.

Eligibility

Minimum Age: 49 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Lleida Biomedical Research Institute (IRBLLEIDA), Lleida, , Spain

Contact Details

Name: Montserrat Rué, PhD

Affiliation: Universitat de Lleida-IRBLLEIDA

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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