- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01628887
Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors
12. juli 2013 opdateret af: City of Hope Medical Center
This clinical trial studies a supportive education program for Latina breast cancer survivors.
The Bilingual Breast Cancer Education Intervention (BBCEI) may help Latina breast cancer survivors know what to expect after completing breast cancer treatment and prepare them to cope with cancer related survivorship issues
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
PRIMARY OBJECTIVES: I. Describe the feasibility of implementing the BBCEI.
II.
Describe the cultural and linguistic appropriateness of the BBCEI.
III.
Determine topics requiring further emphasis in the BBCEI.
IV.
Identify ways to enhance program content, format, and materials.
OUTLINE: Participants undergo 2 tailored BBCEI sessions within 1 month.
At the beginning of the first session the research nurse will present the participants with a list of common physical and social concerns.
The participant will then be asked to identify 3 topics that she wants to discuss.
The research nurse will discuss with the participant any relevant supportive care resources and make the appropriate referrals.
At the second session the focus of the BBCEI will be on psychological and spiritual well-being.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
4
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Duarte, California, Forenede Stater, 91010
- City of Hope Medical Center
-
-
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
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
The population will consist of Latinas with breast cancer who have completed primary cancer treatment. A total of 10 subjects will be accrued.
Inclusion Criteria:
- Diagnosis of Stage I, II or III.
- Self-identification as Hispanic/Latina.
- Able to read and understand English or Spanish to participate in the education sessions.
- Ability to read and/or understand the study protocol requirements, and provide written informed consent
- Subjects maybe be on hormonal therapy after treatment for initial breast cancer.
Exclusion Criteria:
- Actively receiving treatment with surgery, radiation therapy, or chemotherapy.
- Patients who have recurrence, metastasis, or a second primary cancer
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Supportive Care (BBCEI)
Participants undergo 2 tailored BBCEI sessions within 1 month.
At the beginning of the first session the research nurse will present the participants with a list of common physical and social concerns.
The participant will then be asked to identify 3 topics that she wants to discuss.
The research nurse will discuss with the participant any relevant supportive care resources and make the appropriate referrals.
At the second session the focus of the BBCEI will be on psychological and spiritual well-being.
|
Undergo Bilingual Breast Cancer Educational Intervention
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Determine the feasibility of implementation of a Bilingual Breast Cancer Education Intervention (BBCEI)
Tidsramme: 2 months after completion of the educational session
|
A semi-structured interview guide will be used to describe participant satisfaction with the BBCEI.
It allows the patient to describe in their own words whether the BBCEI was effective for their QOL concerns, helpfulness of intervention content, describe the cultural and linguistic appropriateness and identify ways to enhance program content, format and materials.
|
2 months after completion of the educational session
|
Determine the cultural and linguistic appropriateness of the BBCEI
Tidsramme: 2 months after completion of the educational session
|
A semi-structured interview guide will be used to describe participant satisfaction with the BBCEI.
It allows the patient to describe in their own words whether the BBCEI was effective for their QOL concerns, helpfulness of intervention content, describe the cultural and linguistic appropriateness and identify ways to enhance program content, format and materials
|
2 months after completion of the educational session
|
Determine topics requiring further emphasis in the BBCEI
Tidsramme: 2 months after completion of the educational session
|
A semi-structured interview guide will be used to describe participant satisfaction with the BBCEI.
It allows the patient to describe in their own words whether the BBCEI was effective for their QOL concerns, helpfulness of intervention content, describe the cultural and linguistic appropriateness and identify ways to enhance program content, format and materials
|
2 months after completion of the educational session
|
Determine ways to enhance program content, format and materials
Tidsramme: 2 months after completion of the educational session
|
A semi-structured interview guide will be used to describe participant satisfaction with the BBCEI.
It allows the patient to describe in their own words whether the BBCEI was effective for their QOL concerns, helpfulness of intervention content, describe the cultural and linguistic appropriateness and identify ways to enhance program content, format and materials
|
2 months after completion of the educational session
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Gloria Juarez, PhD, City of Hope 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. august 2012
Primær færdiggørelse (Faktiske)
1. juli 2013
Studieafslutning (Faktiske)
1. juli 2013
Datoer for studieregistrering
Først indsendt
25. juni 2012
Først indsendt, der opfyldte QC-kriterier
25. juni 2012
Først opslået (Skøn)
27. juni 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. juli 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juli 2013
Sidst verificeret
1. juli 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 12175
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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