Early Detection of CancerNCT01335906
Evidence-informed Choice for Women Participating in Mammography Screening
A study testing Information in people with Early Detection of Cancer, run by Andaluz Health Service at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 45 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early Detection of Cancer
- What is being tested?
- Information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women with a history of breast cancer
Trial locations and contacts
1 site in 1 country.
Spain1 site
Oncology Unit, Puerta del Mar University Hospital
Cadiz, Andalusia, 11009
About this study
Official title: 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.
- Conditions
- Early Detection of Cancer
- Being tested
- Information
- Keywords
- Cancer Screening Tests, Early Diagnosis of Cancer, Mammography, Informed Consent, Consent Forms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InformationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Evidence-based informed consent | Experimental | Not described Receives: Other: Information |
| Usual information | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before randomization (baseline) and one month later
Secondary outcomes (1)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Detection of CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andaluz Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, José Manuel Baena Cañada, Andaluz Health Service
- Investigators
- José M Baena-Cañada, MD, PhD, Study chair, Oncology Unit, University Hospital Puerta del Mar, CádizPetra Rosado, MD, Study director, Oncology Unit, University Hospital Puerta del Mar, CádizInmaculada Expósito, Chemistry, Principal investigator, Oncology Unit, University Hospital Puerta del Mar, CádizMaría del Carmen Díaz, Chemistry, Principal investigator, Oncology Unit, University Hospital Puerta del Mar, CádizJuan Nieto, MD, Principal investigator, Health District Bay of Cádiz-La Janda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335906
- Sponsor's protocol ID
- PI-0315-2010
- Status last verified
- Jun 2014
- First submitted
- 6 Apr 2011
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of an Evidence-informed Choice Based on Appreciation of Risks and Benefits for Women Participating in Mammography Screening
- ClinicalTrials.gov ID
- NCT01335906
- Acronym / sponsor ID
- PI-0315-2010
- Conditions
- Early Detection of Cancer
- Keywords
- Cancer Screening Tests, Early Diagnosis of Cancer, Mammography, Informed Consent, Consent Forms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Andaluz Health ServiceOther government
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evidence-based informed consent | Experimental | Other: Information |
| Usual information | No intervention | – |
Who may qualify
- Ages
- 45 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Women with a history of breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InformationThe 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. | Other | Evidence-based informed consent |
Primary outcome
Change from baseline in knowledge of women participating in the screening program
Time frame: 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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José M Baena-Cañada, MD, PhD study chair
Oncology Unit, University Hospital Puerta del Mar, Cádiz
Petra Rosado, MD study director
Oncology Unit, University Hospital Puerta del Mar, Cádiz
Inmaculada Expósito, Chemistry principal investigator
Oncology Unit, University Hospital Puerta del Mar, Cádiz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information in people with Early Detection of Cancer, run by Andaluz Health Service at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in knowledge of women participating in the screening program (time frame: Before randomization (baseline) and one month later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2014.