Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway
6. september 2022 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
780
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: Jiyeon Lee, Ph.D
- Telefonnummer: 82-2-2228-3255
- E-post: jiyeonest@yuhs.ac
Studiesteder
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Seoul, Korea, Republikken
- Rekruttering
- Yonsei University
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Ta kontakt med:
- Jiyeon Lee, Ph.D
- Telefonnummer: 82-2-2228-3255
- E-post: jiyeonest@yuhs.ac
-
-
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
19 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: A
Experimental group with application of the standardized care pathways and symptom management education
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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.
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Annen: B
Control group with usual care (symptom monitoring only)
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Control group will receive usual care (symptom monitoring only)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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)
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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)
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Coping measured by brief COPE
Tidsramme: at the visit for cycle 5 of chemotherapy (at average 3 month)
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at the visit for cycle 5 of chemotherapy (at average 3 month)
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Quality of life measured by the EORTC QLQ C-30
Tidsramme: at the visit for cycle 5 of chemotherapy (at average 3 month)
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at the visit for cycle 5 of chemotherapy (at average 3 month)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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)
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at the visit for cycle 5 of chemotherapy (at average 3 month)
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Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation
Tidsramme: at 6 month
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at 6 month
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Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver
Tidsramme: at the visit for cycle 5 of chemotherapy (at average 3 month)
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at the visit for cycle 5 of chemotherapy (at average 3 month)
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Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver
Tidsramme: at 6 month
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at 6 month
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Self-efficacy measured by the Cancer Behavior Inventory 3.0
Tidsramme: at the visit for cycle 5 of chemotherapy (at average 3 month)
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at the visit for cycle 5 of chemotherapy (at average 3 month)
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Self-efficacy measured by the Cancer Behavior Inventory 3.0
Tidsramme: at 6 month
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at 6 month
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Survival
Tidsramme: at 6 month
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at 6 month
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Survival
Tidsramme: at 12 month
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at 12 month
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Symptom measured by the ESAS (Edmonton Symptom Assessment Scale+5 additional symptoms)
Tidsramme: at 6 month
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at 6 month
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Coping measured by brief COPE
Tidsramme: at 6 month
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at 6 month
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Quality of life measured by the EORTC QLQ C-30
Tidsramme: at 6 month
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at 6 month
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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)
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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)
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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)
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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)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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)
23. juni 2020
Primær fullføring (Forventet)
1. februar 2024
Studiet fullført (Forventet)
1. februar 2024
Datoer for studieregistrering
Først innsendt
18. mai 2020
Først innsendt som oppfylte QC-kriteriene
24. mai 2020
Først lagt ut (Faktiske)
29. mai 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. september 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. september 2022
Sist bekreftet
1. september 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 4-2020-0304
Plan for individuelle deltakerdata (IPD)
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NEI
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Nei
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