Clinical trial NCT04603339: ReStOre@Home: Feasibility Study of a 12-week Multidisciplinary Telehealth Rehabilitation Programme for Survivors of Upper Gastrointestinal (UGI) Cancer
Official title: ReStOre@Home: Feasibility Study of a 12-week Multidisciplinary Telehealth Rehabilitation Programme for Survivors of Upper Gastrointestinal (UGI) Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oesophageal Cancer
Gastric Cancer
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Health Research Board, Ireland
First posted: 2020-10-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm feasibility study
Primary purpose: TREATMENT

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.

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%.

Primary outcomes:
measure: Feasibility - Recruitment
timeFrame: Through study completion approx 1 year
measure: Feasibility - adherence
timeFrame: From baseline (T0) to immediately after the program intervention (T1)
measure: Feasibility - acceptability of the intervention (1)
timeFrame: Immediately after the program intervention (T1)
measure: Feasibility - acceptability of the intervention (2)
timeFrame: 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 outcomes:
measure: Change in Cardiorespiratory Fitness from Baseline
timeFrame: Baseline (T0), Immediately after the program intervention (T1)
measure: Physical Performance
timeFrame: Baseline (T0), Immediately after the program intervention (T1)
measure: Hand Grip Strength
timeFrame: Baseline (T0), Immediately after the program intervention (T1)
measure: Physical Activity
timeFrame: Baseline (T0), Immediately after the program intervention (T1)
measure: Weight
timeFrame: Baseline (T0), Immediately after the program intervention (T1)
measure: Height
timeFrame: Baseline (T0), Immediately after the program intervention (T1)
measure: Body Mass Index
timeFrame: Baseline (T0), Immediately after the program intervention (T1)
measure: Circumferential Measurements
timeFrame: Baseline (T0), Immediately after the program intervention (T1)
measure: 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)
timeFrame: Baseline (T0), Immediately after the program intervention (T1)
measure: 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.
timeFrame: Baseline (T0), Immediately after the program intervention (T1)
measure: Fatigue
timeFrame: Baseline (T0), Immediately after the program intervention (T1)
measure: Bio-sample Collection
timeFrame: Baseline (T0), Immediately after the program intervention (T1)
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Trinity College Dublin
state: Leinster
Study officials:
affiliation: University of Dublin, Trinity College
name: Juliette Hussey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.