Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Esophageal Cancer

Stomach Cancer

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

Multidisciplinary rehabilitation programme delivered via telehealth

Juliette Hussey, PhD

Feasibility study of a 12-week multidisciplinary telehealth rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer

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.

ReStOre@Home: Feasibility Study of a 12-week Multidisciplinary Telehealth Rehabilitation Programme for Survivors of Upper Gastrointestinal (UGI) Cancer

Feasibility will be determined by recruitment rate, the number of eligible participants who consent to participation.

Feasibility will also be determined by adherence to the trial intervention, the number of prescribed intervention sessions completed.

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.

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

Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)

Physical Performance will be measured with the Short Physical Performance Battery

Hand Grip strength will be measured with hand held dynamometry

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.

Weight will be recorded by standard measures and reported in kilograms (kg).

Height will be recorded by standard measures and reported in meters (m)

Body Mass Index (BMI) will be calculated as weight (kg)/height (meters(m2)) and reported in kilograms/metres squared (kg/m2).

Mid-arm circumference and waist circumference will be measured with a flexible tape measure and reported in centimeters (cm)

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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ReStOre@Home: Feasibility Study of a 12-week Multidisciplinary Telehealth Rehabilitation Programme for Survivors of Upper Gastrointestinal (UGI) Cancer	NCT04603339	Oesophageal Can... Gastric Cancer	Multidisciplina...	18 Years - 100 Years	University of Dublin, Trinity College
ReStOre@Home: Feasibility Study of a 12-week Multidisciplinary Telehealth Rehabilitation Programme for Survivors of Upper Gastrointestinal (UGI) Cancer	NCT04603339	Oesophageal Can... Gastric Cancer	Multidisciplina...	18 Years - 100 Years	University of Dublin, Trinity College
ReStOre@Home: Feasibility Study of a 12-week Multidisciplinary Telehealth Rehabilitation Programme for Survivors of Upper Gastrointestinal (UGI) Cancer	NCT04603339	Oesophageal Can... Gastric Cancer	Multidisciplina...	18 Years - 100 Years	University of Dublin, Trinity College

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