Evidence-informed Choice for Women Participating in Mammography Screening

Not Applicable

Completed

• Conditions: Early Detection of Cancer
• Interventions: Other: Information

• Registration Number: NCT01335906
• Lead Sponsor: Andaluz Health Service

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-04-06
• Study First Submitted QC: 2011-04-14
• Study First Posted: 2011-04-15
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 332

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evidence-based informed consent	Information	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in knowledge of women participating in the screening program	Before randomization (baseline) and one month later	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

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Oncology Unit, Puerta del Mar University Hospital; 🇪🇸 Cádiz, Andalucía, Spain