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Evidence-informed Choice for Women Participating in Mammography Screening

NCT01335906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2014-06-24

No results posted yet for this study

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.

Conditions

  • Early Detection of Cancer

Interventions

OTHER

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.

Sponsors & Collaborators

  • Andaluz Health Service

    lead OTHER_GOV

Principal Investigators

  • José M Baena-Cañada, MD, PhD · Oncology Unit, University Hospital Puerta del Mar, Cádiz

  • Petra Rosado, MD · Oncology Unit, University Hospital Puerta del Mar, Cádiz

  • Inmaculada Expósito, Chemistry · Oncology Unit, University Hospital Puerta del Mar, Cádiz

  • María del Carmen Díaz, Chemistry · Oncology Unit, University Hospital Puerta del Mar, Cádiz

  • Juan Nieto, MD · Health District Bay of Cádiz-La Janda

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01335906 on ClinicalTrials.gov