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

NCT04603339 | Completed DMC

• 1 other identifier: DIFA-2018-009 - ReStOre@Home
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oesophageal Cancer; Gastric Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• 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)

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Single arm trial, all participants will receive the intervention

Other: Multidisciplinary rehabilitation programme delivered via telehealth

Interventions

Multidisciplinary rehabilitation programme delivered via telehealth OTHER

12 week programme of; 1\) Physiotherapy led aerobic and resistance exercise 2)1:1 Dietetics Counselling 3) Group Multidisciplinary Education Sessions

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be ≥ three months post oesophagectomy, total gastrectomy
• ± neo-adjuvant/adjuvant chemo/chemoradiotherapy with curative intent
• adjuvant therapy must be completed
• access to home broadband

You may not qualify if:

• 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%.

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• Health Research Board, Ireland: collaborator

Study Sites (1)

Trinity College Dublin

Dublin, Leinster, Ireland

Location

Related Publications (1)

• 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.

  PMID: 34046552 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Juliette Hussey, PhD

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physiotherapy

Model Details: Single arm feasibility study

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 26, 2020
• Study Start: May 1, 2021
• Primary Completion: October 30, 2021
• Study Completion: January 1, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)