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

Gastric Cancer Clinical Trial

— ReStOre@Home  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04603339
• Other study ID #: DIFA-2018-009 - ReStOre@Home
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: April 2022
• Source: University of Dublin, Trinity College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 1, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Gastric Cancer
• Oesophageal Cancer

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

Locations

Country	Name	City	State
Ireland	Trinity College Dublin	Dublin	Leinster

Sponsors (2)

Lead Sponsor	Collaborator
University of Dublin, Trinity College	Health Research Board, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - Recruitment	Feasibility will be determined by recruitment rate, the number of eligible participants who consent to participation.	Through study completion approx 1 year
Primary	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)
Primary	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)
Primary	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	Change in Cardiorespiratory Fitness from Baseline	Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)	Baseline (T0), Immediately after the program intervention (T1)
Secondary	Physical Performance	Physical Performance will be measured with the Short Physical Performance Battery	Baseline (T0), Immediately after the program intervention (T1)
Secondary	Hand Grip Strength	Hand Grip strength will be measured with hand held dynamometry	Baseline (T0), Immediately after the program intervention (T1)
Secondary	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)
Secondary	Weight	Weight will be recorded by standard measures and reported in kilograms (kg).	Baseline (T0), Immediately after the program intervention (T1)
Secondary	Height	Height will be recorded by standard measures and reported in meters (m)	Baseline (T0), Immediately after the program intervention (T1)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)