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Evidence-informed Choice for Women Participating in Mammography Screening

A

Andaluz Health Service

Status

Completed

Conditions

Early Detection of Cancer

Treatments

Other: Information

Study type

Interventional

Funder types

Other

Identifiers

NCT01335906
PI-0315-2010

Details and patient eligibility

About

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.

Enrollment

332 patients

Sex

Female

Ages

45 to 69 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

332 participants in 2 patient groups

Evidence-based informed consent
Experimental group
Treatment:
Other: Information
Usual information
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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