Evidence-informed Choice for Women Participating in Mammography Screening

A Randomized Trial of an Evidence-informed Choice Based on Appreciation of Risks and Benefits for Women Participating in Mammography Screening

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.

Study Overview

• Status: Completed
• Conditions: Early Detection of Cancer
• Intervention / Treatment: Other: Information

• Study Type: Interventional
• Enrollment (Actual): 332
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Andalucía
    • Cádiz, Andalucía, Spain, 11009
      • Oncology Unit, Puerta del Mar University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in knowledge of women participating in the screening program	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.	Before randomization (baseline) and one month later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attitudes, intention to participate, fear and anxiety of women participating in the screening program	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.	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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: April 6, 2011
• First Submitted That Met QC Criteria: April 14, 2011
• First Posted (Estimate): April 15, 2011

Study Record Updates

• Last Update Posted (Estimate): June 24, 2014
• Last Update Submitted That Met QC Criteria: June 23, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Mammography; Informed Consent; Cancer Screening Tests; Early Diagnosis of Cancer; Consent Forms
• Other Study ID Numbers: PI-0315-2010