Pre-operative Prehabilitation in Cancer Surgery - Objective Recovery Assessment (Popcorn)
26. februar 2022 opdateret af: Bergthor Björnsson, Linkoeping University
To compare prehabilitation with physical exercise, psychological support, nutritional support and smoke/alchol stop to "standard of care" before canceer surgery.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
90
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Bergthor Björnsson, MD, PhD
- Telefonnummer: +46703766890
- E-mail: bergthor.bjornsson@liu.se
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Patients, aged 18 or older, who have been evaluated as eligible for surgery for malignancy in the esophagus, rectum or liver (only metastases from colorectal cancer) will be evaluated for participation.
Exclusion Criteria:
- Surgery is scheduled in less than 12 weeks.
- Paralytic or completely immobilized patient, condition making physical training impractical.
- Cognitive disability making participation impossible.
- Not speaking or understanding the Swedish language well enough to read and understand the informed consent form.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Prehabilitation
Prehabilitation with physical exercise, psychological support, nutritional support and smoking/alchohol stop
|
prehabilitation
|
|
Aktiv komparator: Standard care
Standard preoperative recomendations
|
No intervention
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
6 minute walk test (6mwt)
Tidsramme: 12 weeks
|
6 minute walk test (6mwt)
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Samlet overlevelse
Tidsramme: 5 år
|
Samlet overlevelse
|
5 år
|
|
30 s chair stand test
Tidsramme: 12 weeks
|
30 s chair stand test
|
12 weeks
|
|
Test of hand grip strength
Tidsramme: 12 weeks
|
Test of hand grip strength
|
12 weeks
|
|
International Physical Activity Questionnaire
Tidsramme: 12 weeks
|
International Physical Activity Questionnaire
|
12 weeks
|
|
Cardiopulmonary exercise test with ventilatory gas analysis
Tidsramme: 12 weeks
|
Cardiopulmonary exercise test with ventilatory gas analysis making it possible to calculate VOmax as well as other established measures of cardiopulmonary function
|
12 weeks
|
|
The presence of malnutrition evaluated with the Global Leadership Initiative on Malnutrition (GLM) criteria
Tidsramme: 12 weeks
|
The presence of malnutrition evaluated with the Global Leadership Initiative on Malnutrition (GLM) criteria
|
12 weeks
|
|
Appetite and eating behavior is evaluated with Eating Symptom Questionnaire (ESQ)
Tidsramme: 12 weeks
|
Appetite and eating behavior is evaluated with Eating Symptom Questionnaire (ESQ)
|
12 weeks
|
|
Appetite and eating behavior is evaluated with Disease Related Appetite Questionnaire (DRAQ)
Tidsramme: 12 weeks
|
Appetite and eating behavior is evaluated with Disease Related Appetite Questionnaire (DRAQ)
|
12 weeks
|
|
4-week point prevalence of smoking abstinence (among baseline smokers)
Tidsramme: 12 weeks
|
4-week point prevalence of smoking abstinence (among baseline smokers), measured with Fagerstroms scale
|
12 weeks
|
|
Weekly alcohol consumption
Tidsramme: 12 weeks
|
Weekly alcohol consumption as reported in standard units
|
12 weeks
|
|
Episodes of heavy drinking per month
Tidsramme: 12 weeks
|
Episodes of heavy drinking per month as reported in standard units at a single occation
|
12 weeks
|
|
The most severe complication occurring
Tidsramme: 90d after surgery
|
The most severe complication occurring (according to the Clavien-Dindo scale) until 90 days after surgery
|
90d after surgery
|
|
Sum of all complications in each patient (comprehensive complication index, CCI)
Tidsramme: 90d after surgery
|
Sum of all complications in each patient (comprehensive complication index, CCI) occuring up to 90 days after surgery
|
90d after surgery
|
|
Length of hospitalization
Tidsramme: 90d after surgery
|
Length of hospitalization
|
90d after surgery
|
|
Time to functional recovery of physical status as compared to baseline values
Tidsramme: 90d after surgery
|
Defined as number of days after surgery until the patient has reached all of the following: being mobile at the preoperative level, having sufficient pain control with only oral or transdermal medication, being able to maintain food intake without intravenous fluids and not being in need of intravenous medications
|
90d after surgery
|
|
Clinical Frailty Scale
Tidsramme: 12 weeks
|
Clinical Frailty Scale
|
12 weeks
|
|
Grade of sarcopenia
Tidsramme: 12 weeks
|
Grade of sarcopenia
|
12 weeks
|
|
The frequency of failures to go through the full treatment program as planned at the first MDT (including, but not limited to, the full oncological chemotherapy program, radiation treatment and final surgery)
Tidsramme: 90 days
|
The frequency of failures to go through the full treatment program as planned at the first MDT (including, but not limited to, the full oncological chemotherapy program, radiation treatment and final surgery)
|
90 days
|
|
Time from surgery until the day of first dose of adjuvant chemotherapy (among liver and rectal cancer patients for whom postoperative chemotherapy is planned)
Tidsramme: 90 day after surgery
|
Time from surgery until the day of first dose of adjuvant chemotherapy (among liver and rectal cancer patients for whom postoperative chemotherapy is planned)
|
90 day after surgery
|
|
Proportion of patients not able to receive all treatment despite no dissemination of disease
Tidsramme: 90 day after surgery
|
Proportion of patients not able to receive all treatment despite no dissemination of disease
|
90 day after surgery
|
|
Quality of Life (QoL)
Tidsramme: 2 years after surgery
|
Quality of Life (QoL)
|
2 years after surgery
|
|
Incremental cost-effectiveness ratio
Tidsramme: 2 years after surgery
|
Incremental cost-effectiveness ratio, calculated as the median cost divided by the quality adjusted life years obtained until 2 years after surgery
|
2 years after surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Bergthor Björnsson, MD, PhD, Linkoping University
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 (Forventet)
1. marts 2022
Primær færdiggørelse (Forventet)
1. december 2023
Studieafslutning (Forventet)
1. december 2023
Datoer for studieregistrering
Først indsendt
16. februar 2022
Først indsendt, der opfyldte QC-kriterier
26. februar 2022
Først opslået (Faktiske)
8. marts 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. marts 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. februar 2022
Sidst verificeret
1. februar 2022
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- POPCORN
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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