Evidence-informed Choice for Women Participating in Mammography Screening

NCT01335906 | Completed

• 1 other identifier: PI-0315-2010
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cancer Screening Tests; Early Diagnosis of Cancer; Mammography; Informed Consent; Consent Forms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Attitudes, intention to participate, fear and anxiety of women participating in the screening program

  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

Study Arms (2)

Evidence-based informed consent

EXPERIMENTAL

Other: Information

Usual information

NO INTERVENTION

Interventions

Information 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.

Evidence-based informed consent

Eligibility Criteria

• Age: 45 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women with a history of breast cancer

Sponsors & Collaborators

• Andaluz Health Service: lead

Study Sites (1)

Oncology Unit, Puerta del Mar University Hospital

Cadiz, Andalusia, 11009, Spain

Location

Study Officials

• José M Baena-Cañada, MD, PhD

  Oncology Unit, University Hospital Puerta del Mar, Cádiz

  STUDY CHAIR

• Petra Rosado, MD

  Oncology Unit, University Hospital Puerta del Mar, Cádiz

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 15, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 24, 2014

Record last verified: 2014-06

Locations

ES (1)