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

5. april 2022 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention Arm
Single arm trial, all participants will receive the intervention
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility - Recruitment
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Cardiorespiratory Fitness from Baseline
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Dublin, Trinity College

Samarbejdspartnere

Health Research Board, Ireland

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2021

Primær færdiggørelse (Faktiske)

30. oktober 2021

Studieafslutning (Faktiske)

1. januar 2022

Datoer for studieregistrering

Først indsendt

21. september 2020

Først indsendt, der opfyldte QC-kriterier

23. oktober 2020

Først opslået (Faktiske)

26. oktober 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • DIFA-2018-009 - ReStOre@Home

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Kliniske forsøg med Mavekræft

Kliniske forsøg med Multidisciplinary rehabilitation programme delivered via telehealth

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

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Placeringer

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