- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07584239
Prehabilitation Physical Therapy and Relaxation Intervention Program to Promote Resiliency and Operative Success Among Adults Receiving Lung Cancer Surgery, ROAR-LCS Trial
LiveWellLung: A Prehabilitation Intervention Program to Promote Resiliency and Operative Success Among Adults Receiving Lung Cancer Surgery (ROAR-LCS) With Biospecimen Collection
Descripción general del estudio
Estado
Intervención / Tratamiento
- Procedimiento: Colección de muestras biológicas
- Otro: Administración de encuestas
- Otro: Exercise Intervention
- Otro: Exercise Intervention
- Otro: Exercise Intervention
- Procedimiento: Physical Therapy
- Conductual: Relaxation Technique
- Otro: Internet-Based Intervention
- Otro: Text Message-Based Navigation Intervention
Descripción detallada
PRIMARY OBJECTIVE:
I. To evaluate feasibility of the two peri-operative programs, as defined by participant adherence and retention rates within their respective interventions.
EXPLORATORY OBJECTIVE:
I. Associating gut microbiome diversity and T cell senescence profiles (peripheral blood) at baseline and end of study as potential biomarkers of treatment-related toxicity and tumor response to treatment among other clinical secondary outcomes (e.g. surgical complications, overall survival).
OUTLINE: Patients choose which arm (I or II) they would like to participate in, depending upon availability.
ARM I (ROAR-LCS): Patients complete in person physical therapy sessions during weeks with regularly scheduled clinic visits, at first session after surgery, and the final session. These sessions include 10 minutes of a cardiovascular warm up followed up core exercise and resistance training. Patients also complete virtual physical therapy sessions in a similar fashion during weeks in between regularly scheduled clinic visits. Patients complete 6-8 sessions prior to surgery and 12 sessions total (over 3-4 months). Patients receive a portable exercise peddler and resistance bands for at home exercise. Patients complete the exercises at home as instructed during their sessions, at first weekly then increased to twice then three times weekly depending upon tolerance. Patients also complete progressive muscle relaxation exercises during a guided virtual session once weekly and at home individually 3-5 times per week. Patients also undergo blood sample collection on study.
ARM II (BeFitMe): Patients receive access to the BeFitMe application (app) on their smartphone and an Apple watch and exercise flip book for 9 months. Patients are assigned exercises, lasting at least 3 minutes, and receive access to self guided exercise videos. Patients receive motivational text messages to encourage their completion of the exercises once daily. Patients track their exercise and step counts using the app. Patients also undergo blood sample collection on study.
After completion of study intervention, patients are followed up at 1 and 2 years.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: The Ohio State University Comprehensive Cancer Center
- Número de teléfono: 800-293-5066
- Correo electrónico: OSUCCCClinicaltrials@osumc.edu
Ubicaciones de estudio
-
-
Ohio
-
Columbus, Ohio, Estados Unidos, 43210
- Reclutamiento
- Ohio State University Comprehensive Cancer Center
-
Contacto:
- Carolyn J. Presley, MD
- Número de teléfono: 614-293-6453
- Correo electrónico: carolyn.presley@osumc.edu
-
Investigador principal:
- Carolyn J. Presley, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age ≥ 18 years
- Diagnosed with: potentially resectable non small cell lung cancer (NSCLC) stage (9th edition: IB-IIIB)
- Intent to receive surgery following neoadjuvant systemic therapy from the Ohio State University Comprehensive Cancer Center (OSUCCC) Thoracic Oncology Clinic
- Patients who are at least 6 weeks out of the surgery date are eligible to participate
- Willingness to participate and adhere to the study intervention program
- Ability to understand and willingness to sign an informed consent document
Exclusion Criteria:
- Prisoners are excluded from participation
- There is NO exclusion criteria pertaining to Eastern Cooperative Oncology Group (ECOG) performance status, laboratory values, or prior cancer diagnoses
- Patients already enrolled on a therapeutic clinical trial will be excluded from this study as to not confound any exploratory outcomes associated with this trial and/or any clinical trials evaluating novel anti-cancer therapies unless granted permission by the local site principal investigator (PI)
Plan de estudios
¿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 |
|---|---|
|
Experimental: Arm I (ROAR-LCS)
Patients complete in person physical therapy sessions during weeks with regularly scheduled clinic visits, at first session after surgery, and the final session.
These sessions include 10 minutes of a cardiovascular warm up followed up core exercise and resistance training.
Patients also complete virtual physical therapy sessions in a similar fashion during weeks in between regularly scheduled clinic visits.
Patients complete 6-8 sessions prior to surgery and 12 sessions total (over 3-4 months).
Patients receive a portable exercise peddler and resistance bands for at home exercise.
Patients complete the exercises at home as instructed during their sessions, at first weekly then increased to twice then three times weekly depending upon tolerance.
Patients also complete progressive muscle relaxation exercises during a guided virtual session once weekly and at home individually 3-5 times per week.
Patients also undergo blood sample collection on study.
|
Someterse a la recolección de muestras de sangre
Otros nombres:
Estudios complementarios
Complete exercises at home
Receive portable exercise peddler and resistance bands
Complete assigned exercises
Complete physical therapy sessions
Otros nombres:
Complete progressive muscle relaxation
|
|
Experimental: Arm II (BeFitMe)
Patients receive access to the BeFitMe app on their smartphone and an Apple watch and exercise flip book for 9 months.
Patients are assigned exercises, lasting at least 3 minutes, and receive access to self guided exercise videos.
Patients receive motivational text messages to encourage their completion of the exercises once daily.
Patients track their exercise and step counts using the app.
Patients also undergo blood sample collection on study.
|
Someterse a la recolección de muestras de sangre
Otros nombres:
Estudios complementarios
Complete exercises at home
Receive portable exercise peddler and resistance bands
Complete assigned exercises
Receive access to the BeFitMe application
Receive motivational text messages
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Adherence (feasibility)
Periodo de tiempo: At 12 week follow up session
|
Defined as completion of ≥ 8 of the program sessions (Resiliency and Operative Success among Adults Receiving Lung Cancer Surgery [ROAR-LCS]) and 3 out of the 5 repeated assessments (BeFitMe) at the end of the study period, whichever occurs first.
|
At 12 week follow up session
|
|
Retention (feasibility)
Periodo de tiempo: Up to 6 months post recruitment
|
Defined as the percentage of participants not lost to follow-up at 12 weeks (pre-operative), post-operative (around 12 weeks), and 6 months post recruitment.
|
Up to 6 months post recruitment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Carolyn J Presley, MD, Ohio State University Comprehensive Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
- Técnicas de investigación
- Terapéutica
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Terapias de la mente-cuerpo
- Terapias complementarias
- Terapia conductual
- Psicoterapia
- Disciplinas y actividades de comportamiento
- Rehabilitación
- Manejo de muestras
- Modalidades de fisioterapia
- Terapia de relajación
Otros números de identificación del estudio
- OSU-24288 (Otro identificador: Ohio State University Comprehensive Cancer Center)
- NCI-2026-02426 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
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.
producto fabricado y exportado desde los EE. UU.
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. .
Ensayos clínicos sobre Colección de muestras biológicas
-
Cliniques universitaires Saint-Luc- Université...Université de LiègeReclutamientoFibrosis quística | BiomarcadoresBélgica