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Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway

6. september 2022 opdateret af: Yonsei University

The purpose of this study is to evaluate the efficacy of the standardized care pathway which provides enhanced supportive care for patients with advanced cancer.

A pilot study (single arm pre-post test) will be conducted to evaluate feasibility of applying standardized care pathway to provide enhanced supportive care. A Randomized Controlled Trial will be conducted by randomly allocating participants in a 1:1 ratio to intervention arm (receiving enhanced supportive care according to the standardized care pathway) or control arm (receiving usual care: symptom monitoring only). Participants in the intervention arm will receive enhanced supportive care consisted of symptom management and coping enhancement counseling for 5 times. Data from advanced cancer patients will be collected at baseline (before start of chemotherapy), during chemotherapy (intervention arm), at the visit for cycle 5 of chemotherapy, at 6 month, and at 12 month Data from caregivers will be collected at baseline, 3 month, and 6 month. Primary outcomes will be measured as advanced cancer patients' symptom, coping and quality of life.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

780

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

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

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • adult (age >=19 years old),
  • cancer patients and their family
  • ECOG =<2

Exclusion Criteria:

  • patients with cognitive or psychiatric issue

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: A
Experimental group with application of the standardized care pathways and symptom management education
Andet: Enhanced supportive care based on standardized care pathway
Enhanced supportive care based on standard care pathway is consisted of 1) symptom management (symptom assessment and according management) and 2) coping enhancement (nurse-led counseling). The enhanced supportive care will be provided 5 times, according to the standardized care pathway.
Andet: B
Control group with usual care (symptom monitoring only)
Andet: Control group with usual care
Control group will receive usual care (symptom monitoring only)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Symptom measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms)
Tidsramme: at the visit for cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen) of chemotherapy (at average 3 month)
at the visit for cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen) of chemotherapy (at average 3 month)
Coping measured by brief COPE
Tidsramme: at the visit for cycle 5 of chemotherapy (at average 3 month)
at the visit for cycle 5 of chemotherapy (at average 3 month)
Quality of life measured by the EORTC QLQ C-30
Tidsramme: at the visit for cycle 5 of chemotherapy (at average 3 month)
at the visit for cycle 5 of chemotherapy (at average 3 month)

Sekundære resultatmål

Resultatmål
Tidsramme
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation
Tidsramme: at the visit for cycle 5 of chemotherapy (at average 3 month)
at the visit for cycle 5 of chemotherapy (at average 3 month)
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation
Tidsramme: at 6 month
at 6 month
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver
Tidsramme: at the visit for cycle 5 of chemotherapy (at average 3 month)
at the visit for cycle 5 of chemotherapy (at average 3 month)
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver
Tidsramme: at 6 month
at 6 month
Self-efficacy measured by the Cancer Behavior Inventory 3.0
Tidsramme: at the visit for cycle 5 of chemotherapy (at average 3 month)
at the visit for cycle 5 of chemotherapy (at average 3 month)
Self-efficacy measured by the Cancer Behavior Inventory 3.0
Tidsramme: at 6 month
at 6 month
Survival
Tidsramme: at 6 month
at 6 month
Survival
Tidsramme: at 12 month
at 12 month
Symptom measured by the ESAS (Edmonton Symptom Assessment Scale+5 additional symptoms)
Tidsramme: at 6 month
at 6 month
Coping measured by brief COPE
Tidsramme: at 6 month
at 6 month
Quality of life measured by the EORTC QLQ C-30
Tidsramme: at 6 month
at 6 month
Symptom change measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms): from baseline to 3 month
Tidsramme: At baseline, at the beginning of Cycle 2, Cycle 3, Cycle 4, Cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)(at average 3 month)
At baseline, at the beginning of Cycle 2, Cycle 3, Cycle 4, Cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)(at average 3 month)
Depression change measured by the HADS (Hospital Anxiety and Depression Scale): from baseline to 3 month
Tidsramme: At baseline, at the beginning of Cycle 2, Cycle 3, Cycle 4, Cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)(at average 3 month)
At baseline, at the beginning of Cycle 2, Cycle 3, Cycle 4, Cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)(at average 3 month)

Samarbejdspartnere og efterforskere

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

Sponsor

Yonsei 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 (Faktiske)

23. juni 2020

Primær færdiggørelse (Forventet)

1. februar 2024

Studieafslutning (Forventet)

1. februar 2024

Datoer for studieregistrering

Først indsendt

18. maj 2020

Først indsendt, der opfyldte QC-kriterier

24. maj 2020

Først opslået (Faktiske)

29. maj 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. september 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. september 2022

Sidst verificeret

1. september 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 4-2020-0304

Plan for individuelle deltagerdata (IPD)

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