Choices for Latinas and Clinical Trials
20 luglio 2016 aggiornato da: Amelie Ramirez, The University of Texas Health Science Center at San Antonio
Choices: Increasing Access of Latinas Into Breast Cancer Clinical Trials
"Increasing Access of Latinas into Breast Cancer Clinical Trials" aims to develop and pilot test a multi-communications approach - using a culturally relevant computer video, a tailored booklet and a patient navigator (PN) - to empower Latinas to make informed decisions about breast cancer clinical trials (BCCTs).
Latinos represent 15% of the U.S. population but only 5.6% of participants in National Cancer Institute (NCI) treatment clinical trials, resulting in disparities in cancer outcomes and jeopardizing the generalizability of trial findings.
In response, this study will develop and evaluate communication and health-system-change strategies to facilitate Latinas' access to BCCTs at the Cancer Therapy and Research Center at The University of Texas Health Science Center at San Antonio (CTRC-UTHSCSA).
The CTRC-UTHSCSA, an NCI-designated Cancer Center located in South Texas, serves a culturally and ethnically diverse population that historically has low participation in clinical trials, especially among those with breast cancer, the No. 1 cancer killer of Latinas.
Panoramica dello studio
Descrizione dettagliata
This study features a cohort design with random assignment of 112 Latina breast cancer patients from the CTRC to an intervention (56) or usual care control group (56). The intervention group will receive three components: 1) a culturally sensitive and individually tailored, 30-minute computer-based BCCT educational video; 2) a bilingual, low literacy booklet that encourages patients to communicate with family and friends; and 3) support from a patient navigator. The usual care control group will receive usual care breast cancer clinical trial information materials offered by the CTRC to its eligible patients. The intervention is based in two proven theories - Stages of Change and Social Cognitive Theory - and will feature basic components of individual empowerment, including knowledge, attitudes, skills and self-efficacy beliefs and expectations.
The study has three main phases: Phase 1: Formative Research; Phase 2: Intervention; and Phase 3: Evaluation.
Purpose:
To empower Latinas to make informed decisions about breast cancer clinical trials (BCCTs) by enhancing their knowledge, attitudes, skills and self-efficacy required to support discussion of CT as a treatment option with doctors and family members.
Specific Objectives:
- Increase patient education and awareness, positive attitudes and self-efficacy to enhance their decision-making skills to participate in BCCTs.
- Provide decisional support to make an informed decision regarding participation in BCCTs by encouraging discussion of BCCTs as a treatment option with medical team, family and friends.
- Test the efficacy of a multi-communication intervention to assist Latina breast cancer patients in their decision making process regarding participation in BCCTs.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
77
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Texas
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San Antonio, Texas, Stati Uniti, 78229
- Cancer Therapy and Research Center - CTRC
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
Inclusion Criteria:
- English and Spanish speaking Latinas diagnosed with breast cancer who: attend the CTRC breast clinic and/or other CTRC clinics, have not had their initial doctor consultation to discuss treatment options, have not participated in a clinical trial before, and are eligible to participate in one of the Phase III, Phase IV or selective Phase II breast cancer clinical trials (BCCT) open at the CTRC at the time of diagnosis.
Exclusion Criteria:
- Non-Hispanic women
- Children
- Men
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Intervention
The intervention group will receive three components: 1) a culturally sensitive, individually tailored, 30-minute computer-based BCCT video; 2) a bilingual, low-literacy booklet aimed at encouraging patients to communicate with family and friends and 3) assistance from a patient navigator.
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Intervention includes 1) a 30-minute computer-based video (in English/Spanish), featuring instructional screens, graphics and animation to help participants understand the concepts presented.
It will feature breast cancer patients who have participated in CTs, patients talking to their doctor or nurse and a bilingual narrator to guide participants.
Video content will address common barriers and concerns regarding clinical trials, as well as the informed consent process, and how clinical trials are monitored and reviewed; 2) a bilingual easy to understand booklet with tailored information on clinical trials.
The booklet will include many of the elements and messages featured in the video program; and 3) assistance from a trained, bilingual, bicultural, nurse navigator.
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Nessun intervento: Usual Care
The usual care control group will receive the usual care breast cancer clinical trial information materials offered by the CTRC to their eligible patients.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Attitudes towards clinical trials
Lasso di tempo: Baseline and post intervention survey within 3 months from baseline
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Eight-item scale measuring attitudes towards clinical trials (staging questions)
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Baseline and post intervention survey within 3 months from baseline
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Self-efficacy
Lasso di tempo: Baseline and post intervention survey within 3 months from baseline
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14-item scale measuring self-efficacy regarding seeking information about clinical trials, communication with doctors, family members and friends, confidence in the system, decision making and expectations if enrolled in a clinical trial.
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Baseline and post intervention survey within 3 months from baseline
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Enrollment in a Clinical Trial
Lasso di tempo: within 6 months from baseline
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Participants' medical records will be reviewed to determine enrollment in a CT
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within 6 months from baseline
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Amelie G. Ramirez, DrPH, The University of Texas Health Science Center at San Antonio
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Chalela P, Muñoz E, Gallion JK, Karnad A, Ramirez AG. Empowering Latina breast cancer patients to make informed decisions about clinical trials: A multicommunication approach. Cancer Epidemiol Biomarkers Prev 24(10 Suppl), 2015 [abstract]
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 febbraio 2012
Completamento primario (Effettivo)
1 dicembre 2015
Completamento dello studio (Effettivo)
1 dicembre 2015
Date di iscrizione allo studio
Primo inviato
11 agosto 2015
Primo inviato che soddisfa i criteri di controllo qualità
18 agosto 2015
Primo Inserito (Stima)
20 agosto 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
21 luglio 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 luglio 2016
Ultimo verificato
1 luglio 2016
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HSC20090165H
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .