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

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

Study Overview

• Status: Completed
• Conditions: Gastric Cancer; Oesophageal Cancer
• Intervention / Treatment: Other: Multidisciplinary rehabilitation programme delivered via telehealth

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Leinster
    • Dublin, Leinster, Ireland
      • Trinity College Dublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Single arm trial, all participants will receive the intervention	Other: Multidisciplinary 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College
• Collaborators: Health Research Board, Ireland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DIFA-2018-009 - ReStOre@Home

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No