- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01335906
Evidence-informed Choice for Women Participating in Mammography Screening
23. juni 2014 opdateret af: 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.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
332
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Andalucía
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Cádiz, Andalucía, Spanien, 11009
- Oncology Unit, Puerta del Mar University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
45 år til 69 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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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Ingen indgriben: Usual information
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change from baseline in knowledge of women participating in the screening program
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Attitudes, intention to participate, fear and anxiety of women participating in the screening program
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: José M Baena-Cañada, MD, PhD, Oncology Unit, University Hospital Puerta del Mar, Cádiz
- Studieleder: Petra Rosado, MD, Oncology Unit, University Hospital Puerta del Mar, Cádiz
- Ledende efterforsker: Inmaculada Expósito, Chemistry, Oncology Unit, University Hospital Puerta del Mar, Cádiz
- Ledende efterforsker: María del Carmen Díaz, Chemistry, Oncology Unit, University Hospital Puerta del Mar, Cádiz
- Ledende efterforsker: Juan Nieto, MD, Health District Bay of Cádiz-La Janda
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2011
Primær færdiggørelse (Faktiske)
1. december 2013
Studieafslutning (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
6. april 2011
Først indsendt, der opfyldte QC-kriterier
14. april 2011
Først opslået (Skøn)
15. april 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. juni 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2014
Sidst verificeret
1. juni 2014
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- PI-0315-2010
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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