- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02222337
Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers
Nueva Vida Intervention: Improving QOL in Latina Breast Cancer Survivors and Their Caregivers
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
What is the Nueva Vida Intervention? The "Nueva Vida Intervention: Improving Quality of Life in Latina Breast Cancer Survivors and Their Caregivers" is a randomized controlled trial (RCT) that was co-developed by a Latina breast cancer survivor who is trained as a mental health professional. The program was developed for Nueva Vida, a community-based organization (CBO) in the Washington, DC metropolitan area that serves Latina breast cancer survivors and their families. We are comparing the intervention to the usual services provided at our four partner community-based organizations.
How is the Nueva Vida Intervention Structured? The 8-session psycho-educational quality of life intervention includes group-based skill-building workshops in which Latina survivors and their caregivers are part of concurrently-held but separate groups (survivors in one room; caregivers in another). This separation meets the needs of Latino participants by encouraging them to freely share their experiences and feelings without worrying about upsetting the other person. Five of the eight sessions address core topics: Introduction and The Impact of Cancer on the Family, Stress Management, Improving Communication: Family, Friends, and Providers, Spirituality and Cancer, and Balancing Physical and Emotional Needs.
The remaining three sessions are selected by the intervention participants based on their own needs and interests from the following options: Anger Management, Intimacy after Cancer: Emotional and Sexual, Trauma and Cancer, Role Changes, Understanding Distress and Depression, Myths and Cancer, Including Others in Helping Caregivers, and Putting Our Lives in Order. At the end of the intervention everyone participates in a graduation ceremony.
How does the Nueva Vida Intervention Reflect Latino Values? The Nueva Vida intervention reflects Latino values, including personalismo (warm, personal relationships), familismo (emphasizing the family unit in managing a cancer diagnosis) and framing the sessions as workshops to avoid stigma associated with mental health care.
Where will the Nueva Vida Intervention Study take place? We will evaluate the Nueva Vida Intervention within a multi-site RCT at four community-based organizations in Washington, DC (Nueva Vida), New York, New York (SHARE, Gilda's Club New York City), and San Jose, California (Latinas Contra Cancer).
What is Involved in Study Participation? Latina survivors and their caregivers will be assigned by chance (randomized) to either the Nueva Vida Intervention or to usual care. Survivors and caregivers assigned to usual care can take part in any and all of the services provided at one of the four community-based organizations who are study partners. Both survivors and caregivers will complete informed consent forms and telephone surveys at the beginning of the study, about 4 months later, and again 6 months later. Survivors and caregivers receive gift cards in appreciation of their time for completing the surveys.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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San Jose, California, Estados Unidos, 95110
- Latinas Contra Cancer
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20007
- Nueva Vida
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New York
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New York, New York, Estados Unidos, 10014
- Gilda's Club New York City
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New York, New York, Estados Unidos, 95110
- SHARE
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Survivors: Latina, has been diagnosed with breast cancer, speaks English or Spanish, has a Caregiver who is willing to participate.
- Caregivers: a primary caregiver for a Latina breast cancer survivor, speak English or Spanish
Exclusion Criteria:
- Inability to understand spoken English and/or Spanish and/or
- Cognitive impairment that precludes informed consent (determined by the PIs or Co-Investigators who are mental health professionals).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: Nueva Vida Intervention
Nueva Vida Intervention consists of 8 sessions of a skills-building group held twice a month for 4 months.
Latina survivors and their caregivers arrive at the group together, separate into different rooms to learn the coping and communication skills, and then join together for discussion of the topic.
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The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic.
This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond.
The specific topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.
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Sem intervenção: Usual Care
Usual care as provided by each of our 4 community-based organization partners.
Usual care can include but is not limited to support groups, patient navigation, individual, couple or family therapy.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
PROMIS Physical Functioning
Prazo: 6 months
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Measure Quality of Life physical functioning; 6 items; Sum and then use IRT to standardize the score.
Mean of 50; SD of 10.
Range of the raw score = 6-28; A higher score = higher physical functioning
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6 months
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PROMIS Satisfaction With Social Roles
Prazo: 6 months
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Measure Quality of Life satisfaction with social roles domain; 6 items; Sum and then use IRT to standardize the score.
Mean of 50; SD of 10; Range of the raw score = 6-30; A higher score = higher satisfaction with social roles
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6 months
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PROMIS Anxiety
Prazo: 6 months
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Quality of life: Anxiety; 6 items; Sum and then use IRT to standardize the score.
Mean of 50; SD of 10.
Range of the raw score = 6 to 30.
A higher score = higher anxiety
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6 months
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PROMIS Depression
Prazo: 6 months
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Quality of life: depression; 6 items; Sum and then use IRT to standardize the score.
Mean of 50; SD of 10.
Range of the raw score = 6-30; A higher score = higher depression
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6 months
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PROMIS Fatigue
Prazo: 6 months
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Quality of life: fatigue; 4 items; Sum and then use IRT to standardize the score.
Mean of 50; SD of 10.
Range of the raw score = 4-20; A higher score = higher fatigue
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6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale)
Prazo: 6-months
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Communication with providers in terms of overall satisfaction with communication.
Range for subscale is 1-5; higher scores indicate higher communication satisfaction.
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6-months
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Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)
Prazo: 6 Months
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Self-efficacy; cancer survivors' confidence in coping with cancer and its treatment
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6 Months
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Satisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL)
Prazo: 6-months
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Satisfaction with health care received by the breast cancer survivor from her oncology health care providers or general health care providers
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6-months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kristi D Graves, Ph.D., Georgetown University
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AD-13-5635
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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