Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

5 april 2022 uppdaterad av: Prof Juliette Hussey, University of Dublin, Trinity College
Feasibility study of a 12-week multidisciplinary telehealth rehabilitation programme for survivors of upper gastrointestinal (UGI) cancer

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

12

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Leinster
      • Dublin, Leinster, Irland
        • Trinity College Dublin

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 100 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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%.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intervention Arm
Single arm trial, all participants will receive the intervention

12 week programme of;

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility - Recruitment
Tidsram: Through study completion approx 1 year
Feasibility will be determined by recruitment rate, the number of eligible participants who consent to participation.
Through study completion approx 1 year
Feasibility - adherence
Tidsram: 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.
From baseline (T0) to immediately after the program intervention (T1)
Feasibility - acceptability of the intervention (1)
Tidsram: 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.

Immediately after the program intervention (T1)
Feasibility - acceptability of the intervention (2)
Tidsram: 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
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).

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Cardiorespiratory Fitness from Baseline
Tidsram: Baseline (T0), Immediately after the program intervention (T1)
Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)
Baseline (T0), Immediately after the program intervention (T1)
Physical Performance
Tidsram: Baseline (T0), Immediately after the program intervention (T1)
Physical Performance will be measured with the Short Physical Performance Battery
Baseline (T0), Immediately after the program intervention (T1)
Hand Grip Strength
Tidsram: Baseline (T0), Immediately after the program intervention (T1)
Hand Grip strength will be measured with hand held dynamometry
Baseline (T0), Immediately after the program intervention (T1)
Physical Activity
Tidsram: 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.
Baseline (T0), Immediately after the program intervention (T1)
Weight
Tidsram: Baseline (T0), Immediately after the program intervention (T1)
Weight will be recorded by standard measures and reported in kilograms (kg).
Baseline (T0), Immediately after the program intervention (T1)
Height
Tidsram: Baseline (T0), Immediately after the program intervention (T1)
Height will be recorded by standard measures and reported in meters (m)
Baseline (T0), Immediately after the program intervention (T1)
Body Mass Index
Tidsram: 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).
Baseline (T0), Immediately after the program intervention (T1)
Circumferential Measurements
Tidsram: 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)
Baseline (T0), Immediately after the program intervention (T1)
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)
Tidsram: 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.

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

Baseline (T0), Immediately after the program intervention (T1)
Fatigue
Tidsram: 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.
Baseline (T0), Immediately after the program intervention (T1)
Bio-sample Collection
Tidsram: 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.
Baseline (T0), Immediately after the program intervention (T1)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2021

Primärt slutförande (Faktisk)

30 oktober 2021

Avslutad studie (Faktisk)

1 januari 2022

Studieregistreringsdatum

Först inskickad

21 september 2020

Först inskickad som uppfyllde QC-kriterierna

23 oktober 2020

Första postat (Faktisk)

26 oktober 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 april 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 april 2022

Senast verifierad

1 april 2022

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • DIFA-2018-009 - ReStOre@Home

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera