Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors
12 juli 2013 uppdaterad 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
4
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
Duarte, California, Förenta staterna, 91010
- City of Hope Medical Center
-
-
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
21 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Determine the feasibility of implementation of a Bilingual Breast Cancer Education Intervention (BBCEI)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Gloria Juarez, PhD, City of Hope Medical Center
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 augusti 2012
Primärt slutförande (Faktisk)
1 juli 2013
Avslutad studie (Faktisk)
1 juli 2013
Studieregistreringsdatum
Först inskickad
25 juni 2012
Först inskickad som uppfyllde QC-kriterierna
25 juni 2012
Första postat (Uppskatta)
27 juni 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 juli 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 juli 2013
Senast verifierad
1 juli 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 12175
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