Pre-operative Prehabilitation in Cancer Surgery - Objective Recovery Assessment (Popcorn)
26. februar 2022 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
90
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Bergthor Björnsson, MD, PhD
- Telefonnummer: +46703766890
- E-post: bergthor.bjornsson@liu.se
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 og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Prehabilitation
Prehabilitation with physical exercise, psychological support, nutritional support and smoking/alchohol stop
|
prehabilitation
|
|
Aktiv komparator: Standard care
Standard preoperative recomendations
|
No intervention
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
6 minute walk test (6mwt)
Tidsramme: 12 weeks
|
6 minute walk test (6mwt)
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total overlevelse
Tidsramme: 5 år
|
Total 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Bergthor Björnsson, MD, PhD, Linköping University
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 (Forventet)
1. mars 2022
Primær fullføring (Forventet)
1. desember 2023
Studiet fullført (Forventet)
1. desember 2023
Datoer for studieregistrering
Først innsendt
16. februar 2022
Først innsendt som oppfylte QC-kriteriene
26. februar 2022
Først lagt ut (Faktiske)
8. mars 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. mars 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. februar 2022
Sist bekreftet
1. februar 2022
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- POPCORN
Plan for individuelle deltakerdata (IPD)
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NEI
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