Evidence-informed Choice for Women Participating in Mammography Screening
23 juni 2014 uppdaterad av: José Manuel Baena Cañada, Andaluz Health Service
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.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
332
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Andalucía
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Cádiz, Andalucía, Spanien, 11009
- Oncology Unit, Puerta del Mar University Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
45 år till 69 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Evidence-based informed consent
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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.
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Inget ingripande: Usual information
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from baseline in knowledge of women participating in the screening program
Tidsram: Before randomization (baseline) and one month later
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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.
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Before randomization (baseline) and one month later
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Attitudes, intention to participate, fear and anxiety of women participating in the screening program
Tidsram: 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
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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.
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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
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: José M Baena-Cañada, MD, PhD, Oncology Unit, University Hospital Puerta del Mar, Cádiz
- Studierektor: Petra Rosado, MD, Oncology Unit, University Hospital Puerta del Mar, Cádiz
- Huvudutredare: Inmaculada Expósito, Chemistry, Oncology Unit, University Hospital Puerta del Mar, Cádiz
- Huvudutredare: María del Carmen Díaz, Chemistry, Oncology Unit, University Hospital Puerta del Mar, Cádiz
- Huvudutredare: Juan Nieto, MD, Health District Bay of Cádiz-La Janda
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2011
Primärt slutförande (Faktisk)
1 december 2013
Avslutad studie (Faktisk)
1 december 2013
Studieregistreringsdatum
Först inskickad
6 april 2011
Först inskickad som uppfyllde QC-kriterierna
14 april 2011
Första postat (Uppskatta)
15 april 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
24 juni 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 juni 2014
Senast verifierad
1 juni 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- PI-0315-2010
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .