- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04603339
ReStOre@Home: Feasibility Study of a 12-week Multidisciplinary Telehealth Rehabilitation Programme for Survivors of Upper Gastrointestinal (UGI) Cancer (ReStOre@Home)
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Leinster
-
Dublin, Leinster, Irlandia
- Trinity College Dublin
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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 |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Feasibility - Recruitment
Ramy czasowe: Through study completion approx 1 year
|
Feasibility will be determined by recruitment rate, the number of eligible participants who consent to participation.
|
Through study completion approx 1 year
|
|
Feasibility - adherence
Ramy czasowe: From baseline (T0) to immediately after the program intervention (T1)
|
Feasibility will also be determined by adherence to the trial intervention, the number of prescribed intervention sessions completed.
|
From baseline (T0) to immediately after the program intervention (T1)
|
|
Feasibility - acceptability of the intervention (1)
Ramy czasowe: Immediately after the program intervention (T1)
|
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)
|
|
Feasibility - acceptability of the intervention (2)
Ramy czasowe: 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).
|
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
|
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).
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Cardiorespiratory Fitness from Baseline
Ramy czasowe: Baseline (T0), Immediately after the program intervention (T1)
|
Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)
|
Baseline (T0), Immediately after the program intervention (T1)
|
|
Physical Performance
Ramy czasowe: Baseline (T0), Immediately after the program intervention (T1)
|
Physical Performance will be measured with the Short Physical Performance Battery
|
Baseline (T0), Immediately after the program intervention (T1)
|
|
Hand Grip Strength
Ramy czasowe: Baseline (T0), Immediately after the program intervention (T1)
|
Hand Grip strength will be measured with hand held dynamometry
|
Baseline (T0), Immediately after the program intervention (T1)
|
|
Physical Activity
Ramy czasowe: Baseline (T0), Immediately after the program intervention (T1)
|
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.
|
Baseline (T0), Immediately after the program intervention (T1)
|
|
Weight
Ramy czasowe: Baseline (T0), Immediately after the program intervention (T1)
|
Weight will be recorded by standard measures and reported in kilograms (kg).
|
Baseline (T0), Immediately after the program intervention (T1)
|
|
Height
Ramy czasowe: Baseline (T0), Immediately after the program intervention (T1)
|
Height will be recorded by standard measures and reported in meters (m)
|
Baseline (T0), Immediately after the program intervention (T1)
|
|
Body Mass Index
Ramy czasowe: Baseline (T0), Immediately after the program intervention (T1)
|
Body Mass Index (BMI) will be calculated as weight (kg)/height (meters(m2)) and reported in kilograms/metres squared (kg/m2).
|
Baseline (T0), Immediately after the program intervention (T1)
|
|
Circumferential Measurements
Ramy czasowe: Baseline (T0), Immediately after the program intervention (T1)
|
Mid-arm circumference and waist circumference will be measured with a flexible tape measure and reported in centimeters (cm)
|
Baseline (T0), Immediately after the program intervention (T1)
|
|
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)
Ramy czasowe: Baseline (T0), Immediately after the program intervention (T1)
|
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.
Ramy czasowe: 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)
|
|
Fatigue
Ramy czasowe: Baseline (T0), Immediately after the program intervention (T1)
|
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.
|
Baseline (T0), Immediately after the program intervention (T1)
|
|
Bio-sample Collection
Ramy czasowe: Baseline (T0), Immediately after the program intervention (T1)
|
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.
|
Baseline (T0), Immediately after the program intervention (T1)
|
Współpracownicy i badacze
Współpracownicy
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- DIFA-2018-009 - ReStOre@Home
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .