Clinical trial NCT01335906: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Detection of Cancer
Keywords: Cancer Screening Tests
Early Diagnosis of Cancer
Mammography
Informed Consent
Consent Forms
Lead sponsor: Andaluz Health Service
Sponsor class: OTHER_GOV
First posted: 2011-04-15
Enrollment: 332
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: Inclusion Criteria:

* Women living in the Bay Health District Cádiz-La Janda
* Women aged between 45 and 69 years
* Women invited to breast screening program and who attend it
* Qualified women to give informed consent to participate in the study

Exclusion Criteria:

* Women with a history of breast cancer

Primary outcomes:
measure: Change from baseline in knowledge of women participating in the screening program
timeFrame: Before randomization (baseline) and one month later
Secondary outcomes:
measure: Attitudes, intention to participate, fear and anxiety of women participating in the screening program
timeFrame: Before randomization (baseline) and one month later. Two years later, women will be called to the follow-up mammography. At this time the real choice taken by woman will be investigated
Other outcomes:
Locations:
city: Cádiz
country: Spain
facility: Oncology Unit, Puerta del Mar University Hospital
state: Andalucía
Study officials:
affiliation: Oncology Unit, University Hospital Puerta del Mar, Cádiz
name: José M Baena-Cañada, MD, PhD
role: STUDY_CHAIR
affiliation: Oncology Unit, University Hospital Puerta del Mar, Cádiz
name: Petra Rosado, MD
role: STUDY_DIRECTOR
affiliation: Oncology Unit, University Hospital Puerta del Mar, Cádiz
name: Inmaculada Expósito, Chemistry
role: PRINCIPAL_INVESTIGATOR
affiliation: Oncology Unit, University Hospital Puerta del Mar, Cádiz
name: María del Carmen Díaz, Chemistry
role: PRINCIPAL_INVESTIGATOR
affiliation: Health District Bay of Cádiz-La Janda
name: Juan Nieto, MD
role: PRINCIPAL_INVESTIGATOR
References: