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Completed

NCT Number: NCT04603339

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

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

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Key information

Conditions

Oesophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trinity College Dublin

Dublin, Leinster, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

Multidisciplinary rehabilitation programme delivered via telehealth

Other

12 week programme of;

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

Primary outcomes

  1. Feasibility - Recruitment

    Time frame: Through study completion approx 1 year

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

  2. Feasibility - adherence

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

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

  3. Feasibility - acceptability of the intervention (1)

    Time frame: Immediately after the program intervention (T1)

    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.

  4. Feasibility - acceptability of the intervention (2)

    Time frame: 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).

    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

Secondary outcomes

  1. Change in Cardiorespiratory Fitness from Baseline

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

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

  2. Physical Performance

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

    Physical Performance will be measured with the Short Physical Performance Battery

  3. Hand Grip Strength

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

    Hand Grip strength will be measured with hand held dynamometry

  4. Physical Activity

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

    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.

  5. Weight

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

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

  6. Height

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

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

  7. Body Mass Index

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

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

  8. Circumferential Measurements

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

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

  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)

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

    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.

  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.

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

    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.

  11. Fatigue

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

    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.

  12. Bio-sample Collection

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

    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.

Sponsors and collaborators

Lead sponsor

University of Dublin, Trinity College

Other

Collaborators

  • Health Research Board, Ireland

Registry information

Acronym: ReStOre@Home

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Oct 26, 2020
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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