Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway
6 september 2022 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
780
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jiyeon Lee, Ph.D
- Telefonnummer: 82-2-2228-3255
- E-post: jiyeonest@yuhs.ac
Studieorter
-
-
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Seoul, Korea, Republiken av
- Rekrytering
- Yonsei University
-
Kontakt:
- Jiyeon Lee, Ph.D
- Telefonnummer: 82-2-2228-3255
- E-post: jiyeonest@yuhs.ac
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
19 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- adult (age >=19 years old),
- cancer patients and their family
- ECOG =<2
Exclusion Criteria:
- patients with cognitive or psychiatric issue
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
|
|
Övrig: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Symptom measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms)
Tidsram: 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)
|
|
Coping measured by brief COPE
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
|
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver
Tidsram: at 6 month
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at 6 month
|
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Self-efficacy measured by the Cancer Behavior Inventory 3.0
Tidsram: 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
Tidsram: at 6 month
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at 6 month
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Survival
Tidsram: at 6 month
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at 6 month
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Survival
Tidsram: 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)
Tidsram: at 6 month
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at 6 month
|
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Coping measured by brief COPE
Tidsram: at 6 month
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at 6 month
|
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Quality of life measured by the EORTC QLQ C-30
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
23 juni 2020
Primärt slutförande (Förväntat)
1 februari 2024
Avslutad studie (Förväntat)
1 februari 2024
Studieregistreringsdatum
Först inskickad
18 maj 2020
Först inskickad som uppfyllde QC-kriterierna
24 maj 2020
Första postat (Faktisk)
29 maj 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 september 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 september 2022
Senast verifierad
1 september 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 4-2020-0304
Plan för individuella deltagardata (IPD)
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NEJ
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