Evidence-informed Choice for Women Participating in Mammography Screening

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Early Detection of Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Evidence-based informed consent

Group Type EXPERIMENTAL

Information

Intervention Type OTHER

The experimental information consists of receiving verbal and written evidence-based information about the benefits and risks of mammography screening program. The standard information consists of receiving the information that public institutions provide to the women invited to the screening program.

Usual information

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Information

The experimental information consists of receiving verbal and written evidence-based information about the benefits and risks of mammography screening program. The standard information consists of receiving the information that public institutions provide to the women invited to the screening program.

Intervention Type OTHER

Eligibility Criteria

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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