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| Name | Class |
|---|---|
| Health Research Board, Ireland | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Single arm trial, all participants will receive the intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidisciplinary rehabilitation programme delivered via telehealth | Other | 12 week programme of; 1) Physiotherapy led aerobic and resistance exercise 2)1:1 Dietetics Counselling 3) Group Multidisciplinary Education Sessions |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Recruitment | Feasibility will be determined by recruitment rate, the number of eligible participants who consent to participation. | 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. | 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. | 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 | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiorespiratory Fitness from Baseline | Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET) | Baseline (T0), Immediately after the program intervention (T1) |
| Physical Performance |
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Inclusion Criteria:
Exclusion Criteria:
In addition those with any serious co-morbidity that would impact on exercise participation will be excluded including those with;
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| Name | Affiliation | Role |
|---|---|---|
| Juliette Hussey, PhD | University of Dublin, Trinity College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trinity College Dublin | Dublin | Leinster | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34046552 | Derived | O'Neill L, Guinan E, Brennan L, Doyle SL, O'Connor L, Sheill G, Smyth E, Fairman CM, Segurado R, Connolly D, O'Sullivan J, Reynolds JV, Hussey J. ReStOre@Home: Feasibility study of a virtually delivered 12-week multidisciplinary rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer - study protocol. HRB Open Res. 2021 May 4;3:86. doi: 10.12688/hrbopenres.13185.2. eCollection 2020. |
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Single arm feasibility study
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Physical Performance will be measured with the Short Physical Performance Battery
| Baseline (T0), Immediately after the program intervention (T1) |
| Hand Grip Strength | Hand Grip strength will be measured with hand held dynamometry | 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. | Baseline (T0), Immediately after the program intervention (T1) |
| Weight | Weight will be recorded by standard measures and reported in kilograms (kg). | Baseline (T0), Immediately after the program intervention (T1) |
| Height | Height will be recorded by standard measures and reported in meters (m) | 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). | 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) | 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. | 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. | 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. | 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. | Baseline (T0), Immediately after the program intervention (T1) |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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