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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
12 week programme of; 1\) Physiotherapy led aerobic and resistance exercise 2)1:1 Dietetics Counselling 3) Group Multidisciplinary Education Sessions
Trinity College Dublin
Dublin, Leinster, Ireland
Feasibility - Recruitment
Feasibility will be determined by recruitment rate, the number of eligible participants who consent to participation.
Time frame: Through study completion approx 1 year
Feasibility - adherence
Feasibility will also be determined by adherence to the trial intervention, the number of prescribed intervention sessions completed.
Time frame: From baseline (T0) to immediately after the program intervention (T1)
Feasibility - acceptability of the intervention (1)
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.
Time frame: Immediately after the program intervention (T1)
Feasibility - acceptability of the intervention (2)
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
Time frame: 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).
Change in Cardiorespiratory Fitness from Baseline
Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)
Time frame: Baseline (T0), Immediately after the program intervention (T1)
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Physical Performance
Physical Performance will be measured with the Short Physical Performance Battery
Time frame: Baseline (T0), Immediately after the program intervention (T1)
Hand Grip Strength
Hand Grip strength will be measured with hand held dynamometry
Time frame: Baseline (T0), Immediately after the program intervention (T1)
Physical Activity
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.
Time frame: Baseline (T0), Immediately after the program intervention (T1)
Weight
Weight will be recorded by standard measures and reported in kilograms (kg).
Time frame: Baseline (T0), Immediately after the program intervention (T1)
Height
Height will be recorded by standard measures and reported in meters (m)
Time frame: Baseline (T0), Immediately after the program intervention (T1)
Body Mass Index
Body Mass Index (BMI) will be calculated as weight (kg)/height (meters(m2)) and reported in kilograms/metres squared (kg/m2).
Time frame: Baseline (T0), Immediately after the program intervention (T1)
Circumferential Measurements
Mid-arm circumference and waist circumference will be measured with a flexible tape measure and reported in centimeters (cm)
Time frame: 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)
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.
Time frame: 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.
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.
Time frame: Baseline (T0), Immediately after the program intervention (T1)
Fatigue
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.
Time frame: Baseline (T0), Immediately after the program intervention (T1)
Bio-sample Collection
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.
Time frame: Baseline (T0), Immediately after the program intervention (T1)