Evidence-informed Choice for Women Participating in Mammography Screening

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
José Manuel Baena Cañada, Andaluz Health Service
ClinicalTrials.gov Identifier:
NCT01335906
First received: April 6, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Early Detection of Cancer
Other: Information

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Randomized Trial of an Evidence-informed Choice Based on Appreciation of Risks and Benefits for Women Participating in Mammography Screening

Resource links provided by NLM:


Further study details as provided by Andaluz Health Service:

Primary Outcome Measures:
  • Change from baseline in knowledge of women participating in the screening program [ Time Frame: Before randomization (baseline) and one month later ] [ Designated as safety issue: No ]
    The primary outcome measure is the level of knowledge obtained in a specific questionnaire, in which there are 7 questions, of which 3 are quantitative with no assumptions and are scored with 2 points. There are also 4 qualitative questions that have 3 assumptions which are scored with 1 point. The maximum score is 10 and minimum 0. It is considered that a woman has made ​​a choice based on adequate knowledge if she gets a score of 6 or more.


Secondary Outcome Measures:
  • Attitudes, intention to participate, fear and anxiety of women participating in the screening program [ Time Frame: 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 ] [ Designated as safety issue: No ]
    The investigators will investigate whether the attitudes of women towards mammography screening are positive or negative. They will respond to 4 questions that are scored from 0 to 6. To know their decision whether to participate in mammography screening they will answer "I am determined to participate" "I am determined not to participate" and "I am undecided". Effective participation will be investigated 2 years later. The level of anxiety and fear of cancer will be measured by "Hospital Anxiety and depression" scale.


Enrollment: 332
Study Start Date: January 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Evidence-based informed consent 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.
No Intervention: Usual information

  Eligibility

Ages Eligible for Study:   45 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335906

Locations
Spain
Oncology Unit, Puerta del Mar University Hospital
Cádiz, Andalucía, Spain, 11009
Sponsors and Collaborators
Andaluz Health Service
Investigators
Study Chair: José M Baena-Cañada, MD, PhD Oncology Unit, University Hospital Puerta del Mar, Cádiz
Study Director: Petra Rosado, MD Oncology Unit, University Hospital Puerta del Mar, Cádiz
Principal Investigator: Inmaculada Expósito, Chemistry Oncology Unit, University Hospital Puerta del Mar, Cádiz
Principal Investigator: María del Carmen Díaz, Chemistry Oncology Unit, University Hospital Puerta del Mar, Cádiz
Principal Investigator: Juan Nieto, MD Health District Bay of Cádiz-La Janda
  More Information

No publications provided

Responsible Party: José Manuel Baena Cañada, MD, PhD, Andaluz Health Service
ClinicalTrials.gov Identifier: NCT01335906     History of Changes
Other Study ID Numbers: PI-0315-2010
Study First Received: April 6, 2011
Last Updated: June 23, 2014
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Andaluz Health Service:
Cancer Screening Tests
Early Diagnosis of Cancer
Mammography
Informed Consent
Consent Forms

ClinicalTrials.gov processed this record on August 28, 2014