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Collaborative Network to Take Responsibility for Oral Anticancer Therapy (CONTACT)

15 de abril de 2019 actualizado por: Lise-Marie Kinnaer, KU Leuven

CONTACT: A Prospective Interventional Multicentre Before-after Study for the Implementation of a Care Pathway to Increase Self-management of Patients With Cancer Who Are Treated With Oral Anticancer Medications

This study aims to develop, implement and evaluate a care pathway for patients with cancer who are treated with oral anticancer drugs (OACD).

The care pathway will be developed in six hospitals in Flanders, and will be adapted to the local setting and situation.

The investigators hypothesize that the implementation of a care pathway will increase the quality of the drug therapy, the communication between health care professionals (HCPs) and patients, and will lead to an improved level of self-management and adherence. Moreover, the invesitgators hypothesize that the care pathway will facilitate the communication between HCPs in the hospital setting and in ambulatory care, and will improve counseling skills, self-efficacy and self-confidence of HCPs.

At the end of the study, a roadmap for the nation-wide implementation of a similar care pathway will be constructed based on the experiences of the participating hospitals. This roadmap will certainly include an e-learning platform for healthcare professionals.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

For each hospital, an individual care pathway will be developed following the 7-phase model by Vanhaecht et al., 2011. This methodology aims to offer a systematic approach in 7 phases for the support of an interdisciplinary team in the development of new care pathways or in the improvement of existing ones.

The before-part of the study includes phases 1 to 4 that aim to map current practice in detail and to translate these findings into the development of a care pathway. Current practice will be investigated using mixed methods comprising:

  • surveys evaluating care on the level of the hospital
  • semi-structured interviews with healthcare professionals (HCP) and patients
  • outcome assessments in patients included in the study (self-management, adherence, satisfaction with care, satisfaction with information, quality of life) using validated questionnaires at the start of the therapy, after 1 month and after three months
  • outcome assessments in healthcare professionals at baseline (self-efficacy and perceptions on self-management) using validated questionnaires
  • training and feedback sessions on counseling for HCPs

Based upon these findings, a care pathway in each hospital will be developed by a local project team of different stakeholders from different disciplines.

The after-part of the study includes phase 5-7 in which the care pathway is implemented, evaluated and continuously followed up.

Implementation and evaluation take place at the same time. The evaluation includes:

  • outcome assessments in patients (newly recruited) at the start of the therapy, after 1 month and after three months
  • outcome assessments in HCPs (follow up)
  • evaluation of counseling skills
  • focus group discussions and interviews with HCPs to evaluate the development and implementation of the care pathway.

At the end of the study a comparison of outcomes before and after the implementation will be made to study the impact of the care pathway on the before mentioned aspects (see "Brief Summary").

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

228

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

  • Bélgica
    • Antwerpen
      • Turnhout, Antwerpen, Bélgica, 2300
        • Reclutamiento
        • AZ Turnhout
        • Contacto:
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Bélgica, 9000
        • Reclutamiento
        • Maria Middelares GENT
        • Contacto:
    • Vlaams-Brabant
      • Bonheiden, Vlaams-Brabant, Bélgica, 2820
        • Reclutamiento
        • Imelda Bonheiden
        • Contacto:
    • West-Vlaanderen
      • Kortrijk, West-Vlaanderen, Bélgica, 8000

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:

  • a hematological cancer of solid tumor
  • starting an oral anticancer drug for the first time
  • able to understand and speak Dutch

Exclusion Criteria:

  • patients following an adjuvant oral anticancer therapy (e.g. tamoxifen)
  • patients following a therapy with a study drug

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: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Non-care pathway

This arm comprises patients before the implementation of the care pathway. Patients starting with an oral anticancer therapy participate in the current care process. Outcomes are assessed at start of treatment, after 1 and after 3 months.

The decision to start with an oral anticancer therapy depends solely on the treating physician.
Experimental: Care Pathway

This arm comprises patients after the implementation of the care pathway. Patients starting with an oral anticancer therapy in this arm, receive care as is described by the novel designed care pathway. Outcomes are again assessed at start of treatment, after 1 and after 3 months.

The decision to start with an oral anticancer therapy depends solely on the treating physician.
Otro: Implementation of a care pathway
The care pathway will consist of procedures of care in the hospital (e.g. consultations with doctors, contact moments with nurses, ...) that describe the initiation of an oral anticancer therapy and the further follow up. The care pathway should describe how care can efficiently be organised.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in self-management skills
Periodo de tiempo: at the start of the therapy, after one and three months

There is no gold standard to define self-management. A definition from Barlow et al., 2002 (2) defines self-management as follows: the ability of an individual to manage the symptoms, treatment, physical and psychosocial consequences and life style changes due to his/her condition. Adequate self-management refers to the ability to monitor one's condition and to effect cognitive, behavioural and emotional responses necessary to maintain a satisfactory quality of life.

The studied self-management skills in this project comprise "social integration and support", "health service navigation", "constructive attitudes and approaches", "skill and technique acquisition" and "emotional distress".
at the start of the therapy, after one and three months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in medication Adherence
Periodo de tiempo: after one and three months of therapy
after one and three months of therapy
Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ)
Periodo de tiempo: after one and three months
after one and three months
Change in patient satisfaction with care using Out-patsat 35
Periodo de tiempo: at the start of the therapy, after one and three months
The outpatsat is a questionnaire for ambulatory cancer patients in which they are asked to rate in different subscales their perceptions on care delivered by doctors, nurses and rate te overall organisation (accessibility of the hospital, ease of reaching the hospital by telephone, ...) during their stay at day hospital of consultations
at the start of the therapy, after one and three months
Health Related Quality of Life
Periodo de tiempo: at the start of the therapy, after one and three months
at the start of the therapy, after one and three months
Change in Distress using the Distress Barometer
Periodo de tiempo: at the start of the therapy, after one and three months
at the start of the therapy, after one and three months
Efficacy of treatment Using ECOG performance scale and RECIST criteria
Periodo de tiempo: at the start of the therapy, after one and three months
at the start of the therapy, after one and three months
Toxicity of treatment
Periodo de tiempo: at the start of the therapy, after one and three months
Summarizing adverse drug events
at the start of the therapy, after one and three months
Cost of care
Periodo de tiempo: at the start of the therapy, after one and three months
Prospective report on health care expenditures (use of healthcare and other services, use of medicines, …)
at the start of the therapy, after one and three months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Self-efficacy in HCPs using the Self-efficacy and Performance in Self-management Instrument (SEPSS)
Periodo de tiempo: at baseline (before the implementation of the care pathway) and after 24 months (during implementation)
SEPSS investigates the ability of a HCP to evaluate their own performance in daily practice and caregiving.
at baseline (before the implementation of the care pathway) and after 24 months (during implementation)
Change in perceptions on self-management in HCPs using the Clinician Support for Patient activation measure
Periodo de tiempo: at baseline (before the implementation of the care pathway) and after 24 months (during implementation)
at baseline (before the implementation of the care pathway) and after 24 months (during implementation)

Colaboradores e Investigadores

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

Patrocinador

KU Leuven

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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

1 de noviembre de 2015

Finalización primaria (Anticipado)

1 de noviembre de 2022

Finalización del estudio (Anticipado)

1 de noviembre de 2022

Fechas de registro del estudio

Enviado por primera vez

2 de agosto de 2016

Primero enviado que cumplió con los criterios de control de calidad

5 de agosto de 2016

Publicado por primera vez (Estimar)

10 de agosto de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de abril de 2019

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

15 de abril de 2019

Última verificación

1 de abril de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • LMK15022016

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

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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