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

Not Applicable

Completed

• Conditions: Gastric Cancer; Oesophageal Cancer
• Interventions: Other: Multidisciplinary rehabilitation programme delivered via telehealth

• Registration Number: NCT04603339
• Lead Sponsor: University of Dublin, Trinity College

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.

Study Timeline

• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-10-23
• Study First Posted: 2020-10-26
• Study Start: 2021-05-01
• Primary Completion: 2021-10-30
• Study Completion: 2022-01-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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%.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Multidisciplinary rehabilitation programme delivered via telehealth	Single arm trial, all participants will receive the intervention

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in Cardiorespiratory Fitness from Baseline	Baseline (T0), Immediately after the program intervention (T1)	Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)
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.
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)
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.
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.

Trial Locations

Locations (1)

Trinity College Dublin; 🇮🇪 Dublin, Leinster, Ireland