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

NCT ID: NCT04603339

Last Updated: 2022-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oesophageal Cancer Gastric Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm feasibility study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Arm

Single arm trial, all participants will receive the intervention

Group Type EXPERIMENTAL

Multidisciplinary rehabilitation programme delivered via telehealth

Intervention Type OTHER

12 week programme of;

1\) Physiotherapy led aerobic and resistance exercise 2)1:1 Dietetics Counselling 3) Group Multidisciplinary Education Sessions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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%.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Health Research Board, Ireland

OTHER

Sponsor Role collaborator

University of Dublin, Trinity College

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof Juliette Hussey

Professor of Physiotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Juliette Hussey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Dublin, Trinity College

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Trinity College Dublin

Dublin, Leinster, Ireland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ireland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34046552 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DIFA-2018-009 - ReStOre@Home

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Symptomatic and Incidental RCC Detection
NCT07004426 NOT_YET_RECRUITING