Evidence-informed Choice for Women Participating in Mammography Screening
This study is currently recruiting participants.
Verified March 2011 by Andaluz Health Service
Sponsor:
Andaluz Health Service
Information provided by:
Andaluz Health Service
ClinicalTrials.gov Identifier:
NCT01335906
First received: April 6, 2011
Last updated: April 14, 2011
Last verified: March 2011
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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.
| Estimated Enrollment: | 332 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2011 (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: 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.
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335906
Contacts
| Contact: Inmaculada Expósito, Chemistry | +34 956004821 | inma.expositoalvarez@gmail.com |
Locations
| Spain | |
| Oncology Unit, Puerta del Mar University Hospital | Recruiting |
| Cádiz, Andalucía, Spain, 11009 | |
| Contact: Inmaculada Expósito, Chemistry 34 956004821 inma.expositoalvarez@gmail.com | |
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 / Principal investigator, Servicio de Oncología Médica, Hospital Universitario Puerta del Mar, Cádiz |
| ClinicalTrials.gov Identifier: | NCT01335906 History of Changes |
| Other Study ID Numbers: | PI-0315-2010 |
| Study First Received: | April 6, 2011 |
| Last Updated: | April 14, 2011 |
| 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 June 18, 2013