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Improving Self-Management in Head and Neck Cancer

14 de enero de 2020 actualizado 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.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Baylor College of Medicine

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
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.
Sin intervención: Usual Medical Care (UMC)
Patients receive standard symptom management education by their health care team.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility of the CST intervention as assessed by recruitment and retention rates
Periodo de tiempo: 6 months
recruitment and retention rates
6 months
Acceptability of the CST intervention as assessed by the program evaluation questionnaire
Periodo de tiempo: 6 months
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
6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PROMIS short form anxiety and depression
Periodo de tiempo: 6 months
measures distress with Patient Reported Outcomes Measurement Information System (PROMIS) short form for anxiety and depression
6 months
Patient QOL measured by MD Anderson Symptom Inventory - Head and Neck (MDASI-HN)
Periodo de tiempo: 6 months
measures QOL for patients
6 months
Partners QOL measured by Short Form 12 (SF12)
Periodo de tiempo: 6 months
measures QOL for partners
6 months
Short Form Dyadic Adjustment Scale (DAS7)
Periodo de tiempo: 6 months
measures Relationship functioning
6 months
Healthcare utilization as assessed by number of hospitalizations and unplanned clinic visits
Periodo de tiempo: 6 months
number of hospitalizations and unplanned clinic visits
6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Hoda Badr, PhD, Icahn School of Medicine at Mount Sinai

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de noviembre de 2014

Finalización primaria (Actual)

1 de octubre de 2018

Finalización del estudio (Actual)

1 de abril de 2019

Fechas de registro del estudio

Enviado por primera vez

1 de abril de 2015

Primero enviado que cumplió con los criterios de control de calidad

3 de abril de 2015

Publicado por primera vez (Estimar)

6 de abril de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de enero de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

14 de enero de 2020

Última verificación

1 de enero de 2020

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • GCO 12-1641
  • R21CA178478 (Subvención/contrato del NIH de EE. UU.)
  • H-48778 (Otro identificador: Baylor College of Medicine)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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