Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer (EQUIP)
Pilot Trial of the Enhancing Quality of Life in Patients (EQUIP) Intervention for Patients With Advanced Lung Cancer
i. Project Background Patients with advanced lung cancer have a high symptom burden and low quality of life. Early palliative care improves patient outcomes in newly diagnosed advanced lung cancer patients, but previously tested models are not feasible for widespread adoption. Hence, the aim of this study is to pilot a more sustainable nurse-led intervention - Enhancing Quality of life in Patients (EQUIP).
ii. Hypothesis / Aim The aims of this study are three-fold. Firstly, the investigators aim to determine the feasibility and acceptability of the EQUIP intervention itself. Secondly, the investigators aim to obtain a tentative estimate of efficacy of the EQUIP intervention. Thirdly, the investigators aim to determine the data completion rate of patient reported outcome measures in the context of the EQUIP trial.
iii. Methods Patients with newly diagnosed stage 3 or stage 4 lung cancer will be recruited and randomized to the EQUIP intervention or usual care (control) group. Patients randomized to the EQUIP intervention group will receive four face-to-face sessions with a palliative care nurse. The content of these educational sessions will equip patients with the knowledge and skills to manage the three commonest symptoms of fatigue, breathlessness and anxiety.
All participants will complete the Functional Assessment of Cancer Therapy - Lung (FACT-L), the Hospital Anxiety and Depression Scale (HADS) and the stigma subscale at four time points: baseline, 4, 8 and 12 weeks after recruitment. Measures of healthcare use will also be recorded. Additionally, participants in the intervention group will complete a feedback survey after each intervention session.
A total sample of 60 patients (30 in each arm) will be recruited.
Clinical Significance
If successful, this study will lead to a larger scale phase III trial which tests various components of the EQUIP intervention, in order to develop a sustainable and effective model for the provision of palliative care to advanced lung cancer patients.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Singapore, Singapur, 169610
- National Cancer Centre Singapore
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria
- Has stage 3 or 4 lung cancer
- ECOG 0,1 or 2
- Able and willing to participate in the EQUIP programme
Exclusion criteria
- Unable to communicate in English or Mandarin
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention
Participants in the EQUIP intervention group will individually receive four face-to-face sessions with a palliative care nurse. For all participants, whether in intervention or control, usual care is provided - the primary oncologist may make a referral for palliative care input if deemed appropriate. |
Patients in the EQUIP intervention group will receive four face-to-face sessions.
The focus of these sessions is to equip patients with the skills and strategies needed to cope with common symptoms experienced by lung cancer patients.
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Sin intervención: Control
For all participants, whether in intervention or control, usual care is provided - the primary oncologist may make a referral for palliative care input if deemed appropriate.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quality of life
Periodo de tiempo: 4 weeks
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Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
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4 weeks
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Quality of life
Periodo de tiempo: 8 weeks
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Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
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8 weeks
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Quality of life
Periodo de tiempo: 12 weeks
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Patient quality of life will be measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire.
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12 weeks
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Psychological distress
Periodo de tiempo: 4 weeks
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Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
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4 weeks
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Psychological distress
Periodo de tiempo: 8 weeks
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Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
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8 weeks
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Psychological distress
Periodo de tiempo: 12 weeks
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Psychological distress will be measured by the Hospital Anxiety and Depression Scale (HADS).
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12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Number of participants with referral to palliative care services
Periodo de tiempo: 6 months
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6 months
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Number of hospital admissions
Periodo de tiempo: 6 months
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6 months
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Number of visits to the emergency department
Periodo de tiempo: 6 months
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6 months
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Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
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Sobrevivencia promedio
Periodo de tiempo: 1 año
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1 año
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Number of participants who died at home
Periodo de tiempo: 1 year
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1 year
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Number of participants with anti-cancer therapy in the last 4 weeks of life
Periodo de tiempo: Last four weeks of life
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Last four weeks of life
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NCCSPG-YR2016-JAN-15
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