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

U

University of Dublin, Trinity College

Status

Completed

Conditions

Oesophageal Cancer
Gastric Cancer

Treatments

Other: Multidisciplinary rehabilitation programme delivered via telehealth

Study type

Interventional

Funder types

Other

Identifiers

NCT04603339
DIFA-2018-009 - ReStOre@Home

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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%.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Intervention Arm
Experimental group
Description:
Single arm trial, all participants will receive the intervention
Treatment:
Other: Multidisciplinary rehabilitation programme delivered via telehealth

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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