- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03162718
A Feasibility Study of Unsupervised, Pre-operative Exercise Program for Patients Scheduled for Lung Cancer Surgery
The paradigm of pre-operative exercise as a neoadjuvant therapy to reduce morbidity is increasingly promoted within general surgery and surgical oncology.
Patients with lung cancer participating in pre-operative exercise have better aerobic capacity and pulmonary function and shorter hospital length-of-stay after surgery. Additionally, pre-operative exercise may increase the likelihood of resuming exercise post-surgery, thereby accelerating the pace of rehabilitation and recovery.
In order to translate the research findings into sustainable clinical practice, clinician-scientists need to develop pragmatic and effective home-based exercise protocols. Wearable fitness devices offer a way to approximate the supervision that occurs in exercise research.
Before the investigators can develop an intervention in which patients receive tailored support similar to what occurs with supervised exercise, they need to pilot test the monitoring aspect of the wearable fitness device in conjunction with the pre-operative exercise program. The investigators propose a mixed methods, 16 single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device. The proposed study of 30 patients scheduled for lung cancer surgery will identify the strengths, weaknesses, and utility of this approach.
Descripción general del estudio
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth-Hitchcock Medical Center
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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:
This study will recruit English-speaking patients who:
- Are over the age of 18 and diagnosed with Stage I-III lung cancer;
- Are able to tolerate surgery (i.e., segmentectomy, lobectomy or bilobectomy) as indicated by standard clinical pre-op evaluation, including pulmonary function tests and cardiac evaluation (if indicated);
- Access to either Wi-Fi or cellular service and permission/ability to download the wearable fitness device app on an apple device, android, or computer (or willingness to use a study-provided iPod to allow the data to be uploaded to the study team);
- Are able to provide voluntary, written consent.
Exclusion Criteria:
Participants will be excluded based on electronic health record (EHR) review (after obtaining HIPAA waiver) if they:
- Have a life expectancy of < 12 months or are receiving hospice services;
- Have a psychiatric diagnosis that would require significant study modification to meet their needs such as uncontrolled severe mental illness, substance abuse, or active suicidal ideation;
- Exhibit American College of Sports Medicine contraindications to exercise which include a resting heart rate of >120bpm, blood pressure >180/100mmHg or unstable angina;31
- Are unable to walk or to complete the 6-minute walk test. According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: single arm
exercise
|
single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Adherence to exercise:
Periodo de tiempo: Time 3, day of surgery
|
number of completed pre-operative exercise sessions divided by number of prescribed sessions, according to exercise log
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Time 3, day of surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Feasibility of recruitment:
Periodo de tiempo: Time 5, 16 weeks post-surgery
|
number of patients enrolled divided by number of patients eligible
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Time 5, 16 weeks post-surgery
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Acceptance of technology
Periodo de tiempo: Time 3, day of surgery
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number of hours the fitness tracker was worn in pre-operative period
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Time 3, day of surgery
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Participant perception of exercise program
Periodo de tiempo: Time 2, 3-5 days before surgery
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semi-structured interview regarding perceptions of the exercise program
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Time 2, 3-5 days before surgery
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Participant perception of fitness tracker
Periodo de tiempo: Time 2, 3-5 days before surgery
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semi-structured interview regarding perceptions of the fitness tracker
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Time 2, 3-5 days before surgery
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Subjective minutes spent in exercise
Periodo de tiempo: Time 3, day of surgery
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Number of minutes spent in exercise according to exercise log
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Time 3, day of surgery
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Objective minutes spent in exercise:
Periodo de tiempo: Time 3, day of surgery
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Number of minutes spent in exercise according to fitness tracker
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Time 3, day of surgery
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Aerobic capacity:
Periodo de tiempo: Time 3, day of surgery
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Six minute walk test
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Time 3, day of surgery
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Pulmonary function:
Periodo de tiempo: Time 2, 3-5 days before surgery
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Diffusion of lungs for carbon monoxide test
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Time 2, 3-5 days before surgery
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Subjective physical function:
Periodo de tiempo: Time 2, 3-5 days before surgery
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PROMIS (Patient-Reported Outcomes Measurement Information System) physical function scale
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Time 2, 3-5 days before surgery
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Objective physical function:
Periodo de tiempo: Time 3, day of surgery
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Grip strength per dynamometer
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Time 3, day of surgery
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Length of stay in hospital:
Periodo de tiempo: Time 4, 2 weeks post-surgery
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Number of days from surgery to discharge home
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Time 4, 2 weeks post-surgery
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Feasibility of Retention
Periodo de tiempo: 16 weeks post-surgery
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Number of patients completing all study assessments divided by the number enrolled
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16 weeks post-surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kathleen D Lyons, ScD, Dartmouth-Hitchcock Medical Center
- Investigador principal: David J Finley, MD, Dartmouth-Hitchcock Medical Center
Publicaciones y enlaces útiles
Publicaciones Generales
- Finley DJ, Stevens CJ, Emond JA, Batsis JA, Fay KA, Darabos C, Sacks OA, Cook SB, Lyons KD. Potential effectiveness of a surgeon-delivered exercise prescription and an activity tracker on pre-operative exercise adherence and aerobic capacity of lung cancer patients. Surg Oncol. 2021 Jun;37:101525. doi: 10.1016/j.suronc.2021.101525. Epub 2021 Mar 5.
- Finley DJ, Fay KA, Batsis JA, Stevens CJ, Sacks OA, Darabos C, Cook SB, Lyons KD. A feasibility study of an unsupervised, pre-operative exercise program for adults with lung cancer. Eur J Cancer Care (Engl). 2020 Jul;29(4):e13254. doi: 10.1111/ecc.13254. Epub 2020 May 29.
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 (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D17044
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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