Evidence-informed Choice for Women Participating in Mammography Screening

Early Detection of Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335906
• Other study ID #: PI-0315-2010
• Status: Completed
• Phase: N/A
• First received: April 6, 2011
• Last updated: June 23, 2014
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: Andaluz Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 69 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Early Detection of Cancer

Intervention

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.

Locations

Country	Name	City	State
Spain	Oncology Unit, Puerta del Mar University Hospital	Cádiz	Andalucía

Sponsors (1)

Lead Sponsor	Collaborator
Andaluz Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No