ReStOre@Home: Feasibility Study of a 12-week Multidisciplinary Telehealth Rehabilitation Programme for Survivors of Upper Gastrointestinal (UGI) Cancer (ReStOre@Home)
5. april 2022 oppdatert 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
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
12
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Leinster
-
Dublin, Leinster, Irland
- Trinity College Dublin
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 100 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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)
|
Samarbeidspartnere og etterforskere
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Samarbeidspartnere
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mai 2021
Primær fullføring (Faktiske)
30. oktober 2021
Studiet fullført (Faktiske)
1. januar 2022
Datoer for studieregistrering
Først innsendt
21. september 2020
Først innsendt som oppfylte QC-kriteriene
23. oktober 2020
Først lagt ut (Faktiske)
26. oktober 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. april 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. april 2022
Sist bekreftet
1. april 2022
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- DIFA-2018-009 - ReStOre@Home
Plan for individuelle deltakerdata (IPD)
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