VOICE: Values and Options in Cancer Care (VOICE)
8 de janeiro de 2019 atualizado por: Ronald Epstein, University of Rochester
Randomized Controlled Trial(RCT)of Patient, Caregiver and Physician Communication Coaching in Advanced Cancer
The purpose of this study is to determine whether a combined intervention for patients, caregivers and oncologists improves communication, quality of life, and quality of care.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The purpose of this study is to (a) determine whether a combined intervention for patients, caregivers and physicians improves communication regarding treatment choices and prognosis in cancer, (b) to determine whether the intervention improves patient and caregiver well-being, quality of life and sense of peace, and (c) to determine whether the intervention affects health services utilization.
Tipo de estudo
Intervencional
Inscrição (Real)
485
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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New York
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Rochester, New York, Estados Unidos, 14642
- University of Rochester
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
21 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria: Physicians
- Currently in clinical practice at participating institutions
- Oncologist that cares for patients with solid tumors
- Not planning to leave the practice during the next 6 months
Inclusion Criteria: Patients
- Currently a patient of an enrolled physician
- Age 21 years or older
- Diagnosis of advanced cancer
- Able to understand spoken English (study personnel will read materials to low literacy patients)
Inclusion Criteria: Caregivers
- Caregiver of a patient currently enrolled in the study
- Age 21 years or older
- Able to understand spoken English (study personnel will read materials to low literacy patients)
Exclusion Criteria: Physicians
- Non Physicians and physicians who are not oncologists
- Oncologists who exclusively care for patients with hematological malignancies
- Prior involvement in health-related coaching interventions
Exclusion Criteria: Patients
- Unable to complete orally-administered surveys in English
- Hospitalized or in hospice care at the time of recruitment
- Prior involvement in health-related coaching interventions
- Anticipating bone marrow transplantation or diagnosed with leukemia or lymphoma
Exclusion Criteria: Caregiver
Unable to complete orally-administered surveys in English
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intervention
Oncologists will receive communication training.
Patients will be coached to make the most of the oncologist visit.
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Oncologists will receive communication training.
Patients will be coached to make the most of the oncologist visit.
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Sem intervenção: Control
Patients will receive usual care
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean Patient-centered Communication in Advanced Cancer Score
Prazo: 3 years
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We audio recorded the first physician visit after the coaching session (for intervention) or after study entry (control).The primary outcome was a composite of 4 pre-specified communication measures: 1. engaging patients in consultations, responding to patients' emotions, informing patients about prognosis and treatment choices and balanced framing of decisions.
Coding of the 4 measures was performed by teams of trained university students who were audited continuously and blinded to study hypotheses and group assignment.
We transformed each of the 4 component scores to z scores based on the pre-randomization phase sample means (SDs): z = (Raw Score - Pre-randomization Phase Mean)/Pre-randomization Phase SD.
The 4-component z-scores were averaged to form the primary outcome.
A higher Z score indicates better communication.
The maximum possible Z-score ranged from -0.69 to 20.08.
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3 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13
Prazo: 7 months
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The prolonged grief (PG-13) instrument was used to measure prolonged grief.
The tool is a sum of ten items that measure separation distress, duration of grief, cognitive, emotional, and behavioral symptoms and impairment criterion.
The range of the score is 10-50 with higher scores indicating more severe symptoms.
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7 months
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Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians
Prazo: 3 years
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Patients and physicians were asked what the likelihood of survival in 2 years would be for the patient.
They chose from 0, 10, 25, 50, 75, 90, 100% chance of survival in two years.
A value of 0-6 was assigned to each pair of data.
0 indicating no difference in the reported value between patient and physician and 6 indicating the largest difference.
For example if the physician said 100% and the patient said 0% the score was 6.
The mean scores were reported by arm.
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3 years
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Aim 2 Patient Well-being
Prazo: 3 years
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Original McGill quality of life and the FACT-G assessment tools were used.
For the McGill tool scores range from 1 to 10 with higher scores indicating better outcome.
For FACT-G scores range from 0 to 4. Higher score means a better outcome.
Different parts of the McGill and FACT-G tools were used to create 5 standardized z scores: McGill QOL Scale single item, McGill Psychological Well-Being sub-scale, McGill Existential Well-Being sub-scale, FACT-G Physical Functioning sub-scale and FACT-G Social Functioning sub-scale.
Sum of the five standardized z-scores is the Aggregate QOL score.
A higher Z score indicates better outcomes.
The maximum possible Z-score ranged from -3.54 to 1.24.
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3 years
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Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment
Prazo: 7 months
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SF-12 scores are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
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7 months
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Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life
Prazo: 3 years
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Patient charts were audited for 3 outcomes : 1) chemotherapy use, 2) aggressive treatments and 3) emergency department or hospital utilization.
The total scores ranged from 0-6 with higher scores indicated worse outcomes.
The sums of the means for the 3 outcomes were added to provide the total score.
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3 years
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ronald Epstein, MD, University of Rochester
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Epstein RM, Duberstein PR, Fenton JJ, Fiscella K, Hoerger M, Tancredi DJ, Xing G, Gramling R, Mohile S, Franks P, Kaesberg P, Plumb S, Cipri CS, Street RL Jr, Shields CG, Back AL, Butow P, Walczak A, Tattersall M, Venuti A, Sullivan P, Robinson M, Hoh B, Lewis L, Kravitz RL. Effect of a Patient-Centered Communication Intervention on Oncologist-Patient Communication, Quality of Life, and Health Care Utilization in Advanced Cancer: The VOICE Randomized Clinical Trial. JAMA Oncol. 2017 Jan 1;3(1):92-100. doi: 10.1001/jamaoncol.2016.4373.
- Hoerger M, Epstein RM, Winters PC, Fiscella K, Duberstein PR, Gramling R, Butow PN, Mohile SG, Kaesberg PR, Tang W, Plumb S, Walczak A, Back AL, Tancredi D, Venuti A, Cipri C, Escalera G, Ferro C, Gaudion D, Hoh B, Leatherwood B, Lewis L, Robinson M, Sullivan P, Kravitz RL. Values and options in cancer care (VOICE): study design and rationale for a patient-centered communication and decision-making intervention for physicians, patients with advanced cancer, and their caregivers. BMC Cancer. 2013 Apr 9;13:188. doi: 10.1186/1471-2407-13-188.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de abril de 2011
Conclusão Primária (Real)
31 de dezembro de 2017
Conclusão do estudo (Real)
31 de dezembro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
30 de novembro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de dezembro de 2011
Primeira postagem (Estimativa)
5 de dezembro de 2011
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de janeiro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de janeiro de 2019
Última verificação
1 de janeiro de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 35388
- R01CA140419-01A2 (Concessão/Contrato do NIH dos EUA)
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