Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors
12. juli 2013 oppdatert av: 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
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
4
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
Duarte, California, Forente stater, 91010
- City of Hope Medical Center
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Gloria Juarez, PhD, City of Hope Medical Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2012
Primær fullføring (Faktiske)
1. juli 2013
Studiet fullført (Faktiske)
1. juli 2013
Datoer for studieregistrering
Først innsendt
25. juni 2012
Først innsendt som oppfylte QC-kriteriene
25. juni 2012
Først lagt ut (Anslag)
27. juni 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
16. juli 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. juli 2013
Sist bekreftet
1. juli 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 12175
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