Gastric Cancer, Oesophageal Cancer
Conditions
Brief summary
Feasibility study of a 12-week multidisciplinary telehealth rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer
Detailed description
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.
Interventions
OTHERMultidisciplinary rehabilitation programme delivered via telehealth
12 week programme of; 1\) Physiotherapy led aerobic and resistance exercise 2)1:1 Dietetics Counselling 3) Group Multidisciplinary Education Sessions
Sponsors
Health Research Board, Ireland
University of Dublin, Trinity College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Recruitment | Through study completion approx 1 year | Feasibility will be determined by recruitment rate, the number of eligible participants who consent to participation. |
| Feasibility - adherence | 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. |
| Feasibility - acceptability of the intervention (1) | 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. |
| Feasibility - acceptability of the intervention (2) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Baseline (T0), Immediately after the program intervention (T1) | Weight will be recorded by standard measures and reported in kilograms (kg). |
| Height | Baseline (T0), Immediately after the program intervention (T1) | Height will be recorded by standard measures and reported in meters (m) |
| Body Mass Index | 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). |
| Circumferential Measurements | 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) |
| Change in Cardiorespiratory Fitness from Baseline | Baseline (T0), Immediately after the program intervention (T1) | Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET) |
| 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. | 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. |
| Fatigue | 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. |
| Bio-sample Collection | 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. |
| 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) | 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. |
| Physical Performance | Baseline (T0), Immediately after the program intervention (T1) | Physical Performance will be measured with the Short Physical Performance Battery |
| Hand Grip Strength | Baseline (T0), Immediately after the program intervention (T1) | Hand Grip strength will be measured with hand held dynamometry |
| Physical Activity | 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. |
Countries
Ireland
Outcome results
None listed