ReStOre@Home: Feasibility Study of a 12-week Multidisciplinary Telehealth Rehabilitation Programme for Survivors of Upper Gastrointestinal (UGI) Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Oesophageal Cancer
- Sponsor
- University of Dublin, Trinity College
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Feasibility - Recruitment
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Prof Juliette Hussey
Professor of Physiotherapy
University of Dublin, Trinity College
Eligibility Criteria
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%.
Outcomes
Primary Outcomes
Feasibility - Recruitment
Time Frame: Through study completion approx 1 year
Feasibility will be determined by recruitment rate, the number of eligible participants who consent to participation.
Feasibility - adherence
Time Frame: 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)
Time Frame: 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)
Time Frame: 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 Outcomes
- Change in Cardiorespiratory Fitness from Baseline(Baseline (T0), Immediately after the program intervention (T1))
- Physical Performance(Baseline (T0), Immediately after the program intervention (T1))
- Hand Grip Strength(Baseline (T0), Immediately after the program intervention (T1))
- Physical Activity(Baseline (T0), Immediately after the program intervention (T1))
- Weight(Baseline (T0), Immediately after the program intervention (T1))
- Height(Baseline (T0), Immediately after the program intervention (T1))
- Body Mass Index(Baseline (T0), Immediately after the program intervention (T1))
- Circumferential Measurements(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)(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.(Baseline (T0), Immediately after the program intervention (T1))
- Fatigue(Baseline (T0), Immediately after the program intervention (T1))
- Bio-sample Collection(Baseline (T0), Immediately after the program intervention (T1))