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Lung Cancer Nurse Model: a Phase II Study (LCN-II)

7 de febrero de 2015 actualizado por: Dr Manuela Eicher, University of Freiburg

Development and Feasibility of a Lung Cancer Nurse Model During Early Treatment: a Phase II Study

Lung cancer patients experience significant physical symptoms, psychological distress and have many supportive care needs that impact on quality of life. Implementing the role of a Lung Cancer Nurse (LCN) is a response to meet the needs of patients and caregivers.

Primary aim is to assess the feasibility of a LCN intervention and feasibility to collect longitudinal patient self-assessment questionnaires at the Thoracic Cancer Centre of the University Hospital of Lausanne.

Secondary aims are: i) to describe self-reported changes in self-efficacy, symptoms and unmet supportive care needs across three time points during the first line therapy and ii) to explore professional acceptability of the new LCN model evaluating the perceptions of barriers and facilitators of the model by the LCN and the other multidisciplinary members of the comprehensive lung cancer care team.

An exact single-stage (no interim analysis) design will be applied to determine feasibility for further studies to be undertaken. Secondary outcomes will be analyzed descriptively at each data collection (Baseline, Time1, Time2) time point and professional acceptability will be explored by focus groups with selected members of the interdisciplinary team.

Descripción general del estudio

Estado

Desconocido

Condiciones

Descripción detallada

To develop adequate self-care strategies, patients with lung cancer and their families are in need of emotional, informational and behavioural supportive care. Supportive care in cancer can reduce symptom burden and improve patients and their families self-management skills. As lung cancer incidence continues to rise, and increased attention is given to early diagnosis, research on early involvement of lung cancer nurse (LCN) in care, the feasibility and impact on patient outcomes is needed.

Primary aim is to assess the feasibility of a LCN intervention and feasibility to collect longitudinal (Baseline, Time1, Time2) patient self-assessment questionnaires at the Thoracic Cancer Centre of the University Hospital of Lausanne.

Secondary aims are: i) to describe self-reported changes in self-efficacy, symptoms and unmet supportive care needs across three time points during the first line therapy and ii) to explore professional acceptability of the new LCN model evaluating the perceptions of barriers and facilitators of the model by the LCN and the other multidisciplinary members of the comprehensive lung cancer care team.

An exact single-stage (no interim analysis) design will be applied to determine feasibility for further studies to be undertaken. Lung cancer patients with planned systemic therapy with or without radiotherapy will be recruited at the thoracic cancer center in a Swiss University Hospital. The LCN model of care consists of two face-to-face consultations alternating with two telephone consultations during systemic therapy. LCN consultations will comprise focused assessment of physical and psychological symptoms, information (printed and oral) about disease and its treatment, therapeutic education concerning strategies to manage physical and psychosocial symptoms and review of available support resources. Participants will be invited to complete the validated patient reported Lung Cancer Symptom Scale, Supportive Care Needs Screening Tool 9 and Self-Efficacy Scale for Lung Cancer. Study data will be collected at baseline (day 1 of systemic therapy), time 1 (week 3 of systemic therapy) and time 2 (week 11 of systemic therapy). Participants will be categorized as adherent if they complete all their scheduled LCN consultations and questionnaires. For a 5% probability of accepting a poor feasibility (alpha) and a 20% probability of rejecting an acceptable feasibility (beta) we then need to enroll 71 patients. Feasibility will be considered as acceptable for further studies if at least 36 patients will be compliant. Secondary outcomes will be analyzed descriptively for each variable (self-efficacy, symptoms and supportive care needs) across each time point. At the end of quantitative data collection, a focus group will be conducted to explore acceptability of the new role among health professionals working with the LCN in order to identify perceived barriers and facilitators for collaborative work with the new role.

Tipo de estudio

De observación

Inscripción (Anticipado)

71

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.

Estudio Contacto

  • Nombre: Andrea Serena, MScN
  • Número de teléfono: 0041 21 314 76 74
  • Correo electrónico: andrea.serena@hefr.ch

Copia de seguridad de contactos de estudio

  • Nombre: Manuela Eicher, Dr.
  • Número de teléfono: 0041 26 429 60 55
  • Correo electrónico: manuela.eicher@hefr.ch

Ubicaciones de estudio

      • Lausanne, Suiza, 1004
        • Reclutamiento
        • University Hospital of Lausanne
        • Contacto:

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

Método de muestreo

Muestra no probabilística

Población de estudio

Lung cancer patients newly diagnosed receiving systemic therapy

Descripción

Inclusion Criteria:

  • Patients newly diagnosed lung cancer (NSCLC or SCLC)
  • Patients capable of speaking and writing in French
  • Patients undergoing programmed a systemic treatment (with or without radiotherapy treatment)
  • Estimated life expectancy more than 6-months
  • Signing the written informed consent document

Exclusion Criteria:

  • Patients diagnosed with lung cancer receiving only surgery treatment or only a radiotherapy treatment
  • Patients not physically or emotionally capable of participating in the trial as determined by their oncologist (existing mental illness or severe physical disability)

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

  • Modelos observacionales: Grupo
  • Perspectivas temporales: Futuro

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility
Periodo de tiempo: 11 weeks
For a 5% probability of accepting a poor feasibility and a 20% probability of rejecting an acceptable feasibility we need to enroll 71 patients. Feasibility will be considered as acceptable for further studies if at least 36 patients reach the end of the study completing their scheduled Lung Cancer Nurse consultations and patients completed the three questionnaire at each data collect time (baseline, time 1 and time 2)
11 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Lung cancer symptoms
Periodo de tiempo: Baseline-Week 3- Week 11
Symptoms will be measured by the Lung Cancer Symptom Scale .This inventory consists of 9 items relating to appetite, fatigue, cough, dyspnea, hemoptysis, and pain related to lung malignancies and three summary items on symptom distress, interference with activity level, and global health-related quality of life. Each item is scored on a visual scale 0-100 (0=no symptom; 100 symptom as bad as can be).
Baseline-Week 3- Week 11
Unmet Supportive Care Need
Periodo de tiempo: Baseline-Week 3- Week 11
Unmet Supportive Care Needs will be measured by the the Supportive Care Needs Survey Screening Tool 9 (SCNS ST 9). The 9 items of the scale fall into five analytically derived factor domains: i) psychological, ii) health system and information, iii) physical and daily living, iv) patient care and support, and v) sexuality. Each item is rated on a 5-point Likert-type scale (not applicable=1; satisfied=2; low need=3; moderate need=4; High need=5).
Baseline-Week 3- Week 11
Self-efficacy
Periodo de tiempo: Baseline-Week 3- Week 11
Self-efficacy will be measured by the Self-Efficacy Scale for lung cancer. This scale is composed by 16 items regarding patients' perceived ability to manage a variety of symptoms on a scale of 10 (not at all certain) to 100 (completely certain). The instrument includes three subscale concerning: i) self-efficacy for managing pain, ii) self-efficacy for managing other symptoms, and iii) self-efficacy for functions.
Baseline-Week 3- Week 11

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Director de estudio: Manuela Eicher, Dr, University of Freiburg

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 enero de 2015

Finalización primaria (Anticipado)

1 de septiembre de 2015

Finalización del estudio (Anticipado)

1 de diciembre de 2015

Fechas de registro del estudio

Enviado por primera vez

7 de febrero de 2015

Primero enviado que cumplió con los criterios de control de calidad

7 de febrero de 2015

Publicado por primera vez (Estimar)

12 de febrero de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

12 de febrero de 2015

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

7 de febrero de 2015

Última verificación

1 de febrero de 2015

Más información

Términos relacionados con este estudio

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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