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Oesophageal CancerReStOre@HomeNCT04603339

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

A study testing Multidisciplinary rehabilitation programme delivered via telehealth in people with Oesophageal Cancer and Gastric Cancer, run by University of Dublin, Trinity College at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Oesophageal Cancer, Gastric Cancer
What is being tested?
Multidisciplinary rehabilitation programme delivered via telehealth
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteIreland
Study dates
1 May 2021to 1 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Ireland1 site

  • Trinity College Dublin

    Dublin, Leinster

Other trials in Ireland

About this study

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

Read the 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.

Being tested
Multidisciplinary rehabilitation programme delivered via telehealth
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multidisciplinary rehabilitation programme delivered via telehealthOther

    12 week programme of;

    1. Physiotherapy led aerobic and resistance exercise 2)1:1 Dietetics Counselling 3) Group Multidisciplinary Education Sessions
Study groups in NCT04603339
Study groupRoleWhat they receive
Intervention ArmExperimentalSingle arm trial, all participants will receive the intervention
Receives: Other: Multidisciplinary rehabilitation programme delivered via telehealth

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility - Recruitment

    Feasibility will be determined by recruitment rate, the number of eligible participants who consent to participation.

    Measured: Through study completion approx 1 year

  2. Feasibility - adherence

    Feasibility will also be determined by adherence to the trial intervention, the number of prescribed intervention sessions completed.

    Measured: From baseline (T0) to immediately after the program intervention (T1)

  3. 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.

    Measured: Immediately after the program intervention (T1)

  4. 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

    Measured: 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)

  1. Change in Cardiorespiratory Fitness from Baseline

    Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)

    Measured: Baseline (T0), Immediately after the program intervention (T1)

  2. Physical Performance

    Physical Performance will be measured with the Short Physical Performance Battery

    Measured: Baseline (T0), Immediately after the program intervention (T1)

  3. Hand Grip Strength

    Hand Grip strength will be measured with hand held dynamometry

    Measured: Baseline (T0), Immediately after the program intervention (T1)

  4. Physical Activity

    Physical activity will be measured using the Godin Shepherd Leisure-Time Exercise Questionnaire. A score of 24 indicates the individual is active, 14-23 indicates moderately active, and less than 14 indicates sedentary/ insufficiently active.

    Measured: Baseline (T0), Immediately after the program intervention (T1)

  5. Weight

    Weight will be recorded by standard measures and reported in kilograms (kg).

    Measured: Baseline (T0), Immediately after the program intervention (T1)

  6. Height

    Height will be recorded by standard measures and reported in meters (m)

    Measured: Baseline (T0), Immediately after the program intervention (T1)

  7. Body Mass Index

    Body Mass Index (BMI) will be calculated as weight (kg)/height (meters(m2)) and reported in kilograms/metres squared (kg/m2).

    Measured: Baseline (T0), Immediately after the program intervention (T1)

  8. Circumferential Measurements

    Mid-arm circumference and waist circumference will be measured with a flexible tape measure and reported in centimeters (cm)

    Measured: Baseline (T0), Immediately after the program intervention (T1)

  9. 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)

    Quality of Life will be determined by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30).

    Scores are reported on a linear scale from 0-100. A high score in a functional scale indicates greater function. A high score in a symptom scale indicates greater symptom burden.

    Measured: Baseline (T0), Immediately after the program intervention (T1)

  10. 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.

    Oesophagogastric cancer specific quality of life will be determined by the EORTC-QLQ-OG25 subscale.

    Scores are reported on a linear scale from 0-100. A high score in a functional scale indicates greater function. A high score in a symptom scale indicates greater symptom burden.

    Measured: Baseline (T0), Immediately after the program intervention (T1)

  11. Fatigue

    Fatigue will be assessed using the Multidimensional Fatigue Inventory (MFI-20) questionnaire. It is scored from 0-20. A cut off score of >or =13 indicates severe fatigue.

    Measured: Baseline (T0), Immediately after the program intervention (T1)

  12. Bio-sample Collection

    Serum, Plasma and Whole Blood samples will be collected at each time-point to establish a survivorship Biobank for UGI cancer. These samples will be stored in the biobank for future to be determined studies.

    Measured: Baseline (T0), Immediately after the program intervention (T1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2020
  2. Study start1 May 2021
  3. Primary completion30 Oct 2021
  4. Study completion1 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm feasibility study
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04603339
Sponsor's protocol ID
DIFA-2018-009 - ReStOre@Home
Acronym
ReStOre@Home
Status last verified
Apr 2022
First submitted
21 Sep 2020
Last updated
13 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34046552

Questions about this trial

What is this clinical trial studying?

A study testing Multidisciplinary rehabilitation programme delivered via telehealth in people with Oesophageal Cancer and Gastric Cancer, run by University of Dublin, Trinity College at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - Recruitment (time frame: Through study completion approx 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04603339, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.

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