Spots Global Cancer Trial Database for Evidence-informed Choice for Women Participating in Mammography Screening
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Trial Identification
Brief Title: Evidence-informed Choice for Women Participating in Mammography Screening
Official Title: A Randomized Trial of an Evidence-informed Choice Based on Appreciation of Risks and Benefits for Women Participating in Mammography Screening
Study ID: NCT01335906
Conditions
Interventions
Study Description
Brief Summary: Study objectives: to evaluate the effects of information about benefits and risks of mammography screening on participants in terms of knowledge, attitude, rates of uptake, fear of cancer, anxiety, and conflict decision. Study hypothesis: information about benefit and risks of mammography screening increases the women´s knowledge of it; allows women to make an informed decision on whether to stop or continue the screening program, changing the actual participation rate; anxiety and fear are not increased. Design: randomized controlled clinical trial with non-pharmacological intervention. Subjects and setting of study: women referred to mammography screening in the District Bay of Cádiz-La Janda. Interventions: random assignment of women in two arms according to the information provided. Control arm is the standard information; it consists of receiving information normally provided to women attending the screening program for breast cancer. Intervention arm is the experimental information and consists of receiving accurate verbal and written information about the benefits and real risks of mammography screening programs by a physician investigator. Determinations: knowledge, attitude, rates of uptake, fear of cancer, anxiety, and conflict decision.
Detailed Description:
Eligibility
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
Oncology Unit, Puerta del Mar University Hospital, Cádiz, Andalucía, Spain
Contact Details
Name: José M Baena-Cañada, MD, PhD
Affiliation: Oncology Unit, University Hospital Puerta del Mar, Cádiz
Role: STUDY_CHAIR
Name: Petra Rosado, MD
Affiliation: Oncology Unit, University Hospital Puerta del Mar, Cádiz
Role: STUDY_DIRECTOR
Name: Inmaculada Expósito, Chemistry
Affiliation: Oncology Unit, University Hospital Puerta del Mar, Cádiz
Role: PRINCIPAL_INVESTIGATOR
Name: María del Carmen Díaz, Chemistry
Affiliation: Oncology Unit, University Hospital Puerta del Mar, Cádiz
Role: PRINCIPAL_INVESTIGATOR
Name: Juan Nieto, MD
Affiliation: Health District Bay of Cádiz-La Janda
Role: PRINCIPAL_INVESTIGATOR
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