- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00594282
Use of a Radiolucent Pad to Reduce Mammography Among African Americans
10. september 2008 opdateret af: University of Kansas
The objective of this study is to assess whether use of a mammography breast plate cushion will significantly decrease the level of discomfort experienced by African American women during routine screening mammograms.
The primary hypothesis is that use of the breast plate cushion will result in less mammography-related discomfort.
The secondary hypotheses are that women who anticipate high levels of discomfort will experience greater reductions in discomfort when a breast plate cushion is used and participants who received mammograms using a breast plate cushion will have greater intentions to return for a routine mammogram than the control group.
Studieoversigt
Detaljeret beskrivelse
Despite improvements over the past decade, routine mammography screening rates among African American women remain suboptimal.
This is especially troubling in light of the fact that African American women have higher breast cancer mortality rates than White and Hispanic women.
Multiple studies have revealed that women experience varying levels of pain during mammography, however, African American women report higher levels of mammography-related pain than their White counterparts.
In fact, the fear of pain associated with mammography is so prominent that it prevents some women from undergoing routine screenings or follow-ups.
Since pain is a major barrier for many African American women in the screening process, studies to assess methods to reduce mammography-related pain are imperative.
An FDA-approved radiolucent breast plate cushion has been developed for use during mammography to increase comfort during the exam.
The purpose of this study is to evaluate whether use of this radiolucent cushion will decrease the level of pain experienced by African American women undergoing routine screening mammography, positively impact routine mammography screening intentions, and result in greater mammography satisfaction among African American women.
304 women scheduled for mammograms at three community metropolitan mammography facilities participated in this study.
One-half of the women were randomized to an Enhanced Mammography (EM) condition in which a radiolucent cushion was used during mammograms.
The other half were randomized to a Routine Mammography (RM) condition during which typical exam protocol is followed and no radiolucent cushion was used.
Pre- and post-exam surveys assessed anticipated and experienced exam-related pain and discomfort, intentions to return for a future routine mammogram, and general visit satisfaction.
A follow-up telephone interview will be conducted with study participants to determine whether they received a follow-up routine screening mammogram 12 to 18 months after they were enrolled in the study (at the time of their last routine screening mammogram) and where they received their mammogram (e.g. did they return to the same facility).
If they did not obtain an on-time routine screening mammogram barriers were assessed.
The RM and EM groups will be compared for differences.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
300
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Medical Center
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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
38 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- African American women
- 40 years of age or older who presented for a routine screening mammogram
Exclusion Criteria:
- Males
- race other than African American
- younger than 40 years of age
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 1
Enhanced Mammography (EM) - Women who are randomized to the Enhanced Mammography (EM) condition will receive a mammogram in which a MammoPad radiolucent breast plate cushion is used.
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MammoPad radiolucent breast plate cushion used during mammogram
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Ingen indgriben: 2
Routine Mammography (RM) - Women who are randomized to the Routine Mammography (RM) condition will obtain a routine, un-altered mammogram during which typical exam protocol will be followed and no radiolucent cushion is used.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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A Pre-Mammography Survey and Post-Mammography Survey to assess anticipated and actual discomfort
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Sekundære resultatmål
Resultatmål |
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Pre-Mammography Survey, Post-Mammography Survey to assess barriers
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Kim K. Engelman, PhD, University of Kansas Medical Center
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. september 2005
Primær færdiggørelse (Faktiske)
1. juli 2007
Datoer for studieregistrering
Først indsendt
2. januar 2008
Først indsendt, der opfyldte QC-kriterier
14. januar 2008
Først opslået (Skøn)
15. januar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
12. september 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. september 2008
Sidst verificeret
1. september 2008
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 9673 (Anden identifikator: CTEP)
- POP053504
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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