ReStOre@Home: Feasibility Study of a 12-week Multidisciplinary Telehealth Rehabilitation Programme for Survivors of Upper Gastrointestinal (UGI) Cancer (ReStOre@Home)
5 de abril de 2022 actualizado por: Prof Juliette Hussey, University of Dublin, Trinity College
Feasibility study of a 12-week multidisciplinary telehealth rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
A single arm feasibility study will be conducted to examine the feasibility of delivering the 12-week ReStOre programme (aerobic and resistance physiotherapy led-exercise, 1:1 dietary counselling and group education sessions) via telehealth to a cohort of upper gastrointestinal cancer survivors.
Tipo de estudio
Intervencionista
Inscripción (Actual)
12
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
-
-
Leinster
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Dublin, Leinster, Irlanda
- Trinity College Dublin
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-
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 a 100 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- be ≥ three months post oesophagectomy, total gastrectomy
- ± neo-adjuvant/adjuvant chemo/chemoradiotherapy with curative intent
- adjuvant therapy must be completed
- access to home broadband
Exclusion Criteria:
- Ongoing serious post-operative morbidity
- Evidence of active or recurrent disease.
In addition those with any serious co-morbidity that would impact on exercise participation will be excluded including those with;
- Uncontrolled hypertension (resting systolic blood pressure >180mmHg and/or diastolic >100mmHg)
- Recent serious cardiovascular events (within 12 months) including, but not limited to cerebrovascular accident, and myocardial infarction
- Unstable cardiac, renal, lung, liver or other severe chronic disease
- Uncontrolled atrial fibrillation
- Left ventricular function <50%.
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: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention Arm
Single arm trial, all participants will receive the intervention
|
12 week programme of; 1) Physiotherapy led aerobic and resistance exercise 2)1:1 Dietetics Counselling 3) Group Multidisciplinary Education Sessions |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility - Recruitment
Periodo de tiempo: Through study completion approx 1 year
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Feasibility will be determined by recruitment rate, the number of eligible participants who consent to participation.
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Through study completion approx 1 year
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Feasibility - adherence
Periodo de tiempo: From baseline (T0) to immediately after the program intervention (T1)
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Feasibility will also be determined by adherence to the trial intervention, the number of prescribed intervention sessions completed.
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From baseline (T0) to immediately after the program intervention (T1)
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Feasibility - acceptability of the intervention (1)
Periodo de tiempo: Immediately after the program intervention (T1)
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Feasibility will also be determined by the acceptability of the programme. Acceptability of the telehealth programme will be assessed by the Telehealth Usability Questionnaire (TUQ). The Telehealth Usability scale is a 5 point likert scale where 1 = completely disagree, and 5 =fully agree, Higher ratings indicate better usability. |
Immediately after the program intervention (T1)
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Feasibility - acceptability of the intervention (2)
Periodo de tiempo: Duration of the trial i.e. From enrolment of the first participant until completion of the final participants post-intervention assessment (Time period of up to 12 months).
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Acceptability of the intervention will be further determined by a qualitative approach.Interviews will be carried out with participants post-intervention to gain their perspectives of the impact of the program on physical and mental well-being and the suitability of the programme to delivery via telehealth
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Duration of the trial i.e. From enrolment of the first participant until completion of the final participants post-intervention assessment (Time period of up to 12 months).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Cardiorespiratory Fitness from Baseline
Periodo de tiempo: Baseline (T0), Immediately after the program intervention (T1)
|
Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)
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Baseline (T0), Immediately after the program intervention (T1)
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Physical Performance
Periodo de tiempo: Baseline (T0), Immediately after the program intervention (T1)
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Physical Performance will be measured with the Short Physical Performance Battery
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Baseline (T0), Immediately after the program intervention (T1)
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Hand Grip Strength
Periodo de tiempo: Baseline (T0), Immediately after the program intervention (T1)
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Hand Grip strength will be measured with hand held dynamometry
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Baseline (T0), Immediately after the program intervention (T1)
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Physical Activity
Periodo de tiempo: Baseline (T0), Immediately after the program intervention (T1)
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Physical activity will be measured using the Godin Shepherd Leisure-Time Exercise Questionnaire.
A score of 24 indicates the individual is active, 14-23 indicates moderately active, and less than 14 indicates sedentary/ insufficiently active.
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Baseline (T0), Immediately after the program intervention (T1)
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Weight
Periodo de tiempo: Baseline (T0), Immediately after the program intervention (T1)
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Weight will be recorded by standard measures and reported in kilograms (kg).
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Baseline (T0), Immediately after the program intervention (T1)
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Height
Periodo de tiempo: Baseline (T0), Immediately after the program intervention (T1)
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Height will be recorded by standard measures and reported in meters (m)
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Baseline (T0), Immediately after the program intervention (T1)
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Body Mass Index
Periodo de tiempo: Baseline (T0), Immediately after the program intervention (T1)
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Body Mass Index (BMI) will be calculated as weight (kg)/height (meters(m2)) and reported in kilograms/metres squared (kg/m2).
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Baseline (T0), Immediately after the program intervention (T1)
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Circumferential Measurements
Periodo de tiempo: Baseline (T0), Immediately after the program intervention (T1)
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Mid-arm circumference and waist circumference will be measured with a flexible tape measure and reported in centimeters (cm)
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Baseline (T0), Immediately after the program intervention (T1)
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Health Related Quality of Life measured by the European Organisation for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30)
Periodo de tiempo: Baseline (T0), Immediately after the program intervention (T1)
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Quality of Life will be determined by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30). Scores are reported on a linear scale from 0-100. A high score in a functional scale indicates greater function. A high score in a symptom scale indicates greater symptom burden. |
Baseline (T0), Immediately after the program intervention (T1)
|
|
Oesophago-gastric cancer specific Health Related Quality of Life will measured by the European Organisation for the Research and Treatment of Cancer Oesophago-gastric Cancer Subscale the EORTC-QLQ-OG25.
Periodo de tiempo: Baseline (T0), Immediately after the program intervention (T1)
|
Oesophagogastric cancer specific quality of life will be determined by the EORTC-QLQ-OG25 subscale. Scores are reported on a linear scale from 0-100. A high score in a functional scale indicates greater function. A high score in a symptom scale indicates greater symptom burden. |
Baseline (T0), Immediately after the program intervention (T1)
|
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Fatigue
Periodo de tiempo: Baseline (T0), Immediately after the program intervention (T1)
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Fatigue will be assessed using the Multidimensional Fatigue Inventory (MFI-20) questionnaire.
It is scored from 0-20.
A cut off score of >or =13 indicates severe fatigue.
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Baseline (T0), Immediately after the program intervention (T1)
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Bio-sample Collection
Periodo de tiempo: Baseline (T0), Immediately after the program intervention (T1)
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Serum, Plasma and Whole Blood samples will be collected at each time-point to establish a survivorship Biobank for UGI cancer.
These samples will be stored in the biobank for future to be determined studies.
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Baseline (T0), Immediately after the program intervention (T1)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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.
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 (Actual)
1 de mayo de 2021
Finalización primaria (Actual)
30 de octubre de 2021
Finalización del estudio (Actual)
1 de enero de 2022
Fechas de registro del estudio
Enviado por primera vez
21 de septiembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
23 de octubre de 2020
Publicado por primera vez (Actual)
26 de octubre de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de abril de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
5 de abril de 2022
Última verificación
1 de abril de 2022
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- DIFA-2018-009 - ReStOre@Home
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
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. .