- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02409485
Improving Self-Management in Head and Neck Cancer
14 de janeiro de 2020 atualizado por: Hoda Badr, Baylor College of Medicine
By teaching skills to improve the coordination of care and support in couples coping with head and neck cancer (HNC), this couple-based psychosocial intervention holds great promise for improving self-management, reducing costly hospitalizations and treatment interruptions, and improving both partners' quality of life.
Home-based delivery will enhance future dissemination and outreach to those who do not have access to psychosocial services or live far away from their care centers.
If found effective, the intervention may also have salutary downstream effects on the health and well-being of HNC patients and their partners.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Patients treated with radiation (XRT) for head and neck cancers (HNCs) experience significant side effects such as abnormally reduced salivation, difficulty swallowing, and taste changes even after they have been definitively treated.
To control side effects and minimize discomfort, intensive self-care protocols are prescribed, but adherence is poor.
Partners (spouses/significant others) can play a critical role in supporting adherence, but often lack knowledge, experience high rates of distress, and display poor communication (e.g., critical or controlling), that can interfere with patient self-care.
The investigators have developed a home-based couples skills-training (CST) intervention that teaches: 1) self-management skills to control/prevent side-effects; 2) communication skills to facilitate coordination of care and support; and 3) strategies to improve communal coping and confidence in the ability to work as a team.
The goal is to reduce healthcare utilization and improve multiple domains of patient and partner QOL.
Specific aims are to: develop and evaluate the content and materials of the CST intervention (AIM 1) and evaluate its feasibility and acceptability (AIM 2).
The multidisciplinary team will review and evaluate the content we have already developed based on the ongoing work with HNC couples (K07).
Once content is finalized, tailored manuals will be developed for patients and partners and evaluated through two focus groups (AIM 1).
The investigators expect that most couples (> 60%) approached will agree to participate and that CST will be well-accepted (AIM 2).
Knowledge gained will be used to refine CST and to collect data on effect sizes and variation for a larger trial.
Innovation: CST takes a multiple-behavioral approach to addressing and preventing HNC treatment side effects and, in the process, seeks to improve multiple domains of QOL.
It is also the first program in HNC that actively involves both members of the couple to address barriers in the home environment in which self-management occurs.
Finally, this study conceptualizes the couple relationship as a resource and leverages that resource to improve patient care and outcomes.
Impact: Home-based delivery will enhance future dissemination and outreach to the target population.
Overall, CST holds great promise for improving patient self-management behaviors, reducing costly hospitalizations and treatment interruptions, and improving multiple aspects of patient and partner QOL.
Tipo de estudo
Intervencional
Inscrição (Real)
60
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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Texas
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Houston, Texas, Estados Unidos, 77030
- Baylor College of Medicine
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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
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- patient is initiating radiotherapy for HNC
- patient has Karnofsky score > 50 (ambulatory & capable of self-care)
- patient lives with a partner (spouse/significant other - includes homo- and heterosexual couples)
- patient/partner is able to provide informed consent
- patient/partner is > age 18.
Exclusion Criteria:
- patient has significant comorbidities (e.g., HIV, transplant), or another illness that may require hospitalization
- patient/partner cannot read or communicate using spoken English.
- individuals with diminished mental capacity
- prisoners
- pregnant women
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: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Couples Skill-Training (CST)
CST provides education about acute and long-term side-effects of HNC and teaches: 1) self-management skills to control/prevent side-effects; 2) communication skills to facilitate coordination of care; and, 3) strategies to improve communal coping and confidence in the ability to work as a team.
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Patients and partners each receive a workbook and 6 one-hour telephone sessions with a Masters level trained interventionist.
Manual content is tailored based on role (patient or partner).
Couples participate together via speaker phone for half the sessions and patients and partners receive separate (individual) intervention calls for the other half of the sessions.
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Sem intervenção: Usual Medical Care (UMC)
Patients receive standard symptom management education by their health care team.
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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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Feasibility of the CST intervention as assessed by recruitment and retention rates
Prazo: 6 months
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recruitment and retention rates
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6 months
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Acceptability of the CST intervention as assessed by the program evaluation questionnaire
Prazo: 6 months
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satisfaction with the intervention by completing a program evaluation questionnaire developed by the study team that asks about perceived skills mastery and satisfaction with program content and logistics
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6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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PROMIS short form anxiety and depression
Prazo: 6 months
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measures distress with Patient Reported Outcomes Measurement Information System (PROMIS) short form for anxiety and depression
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6 months
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Patient QOL measured by MD Anderson Symptom Inventory - Head and Neck (MDASI-HN)
Prazo: 6 months
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measures QOL for patients
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6 months
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Partners QOL measured by Short Form 12 (SF12)
Prazo: 6 months
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measures QOL for partners
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6 months
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Short Form Dyadic Adjustment Scale (DAS7)
Prazo: 6 months
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measures Relationship functioning
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6 months
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Healthcare utilization as assessed by number of hospitalizations and unplanned clinic visits
Prazo: 6 months
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number of hospitalizations and unplanned clinic visits
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6 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Hoda Badr, PhD, Icahn School of Medicine at Mount Sinai
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 novembro de 2014
Conclusão Primária (Real)
1 de outubro de 2018
Conclusão do estudo (Real)
1 de abril de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
1 de abril de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de abril de 2015
Primeira postagem (Estimativa)
6 de abril de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de janeiro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de janeiro de 2020
Última verificação
1 de janeiro de 2020
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- GCO 12-1641
- R21CA178478 (Concessão/Contrato do NIH dos EUA)
- H-48778 (Outro identificador: Baylor College of Medicine)
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