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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Experimental group with application of the standardized care pathways and symptom management education |
|
| B | Other | Control group with usual care (symptom monitoring only) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced supportive care based on standardized care pathway | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms) | 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 | at the visit for cycle 5 of chemotherapy (at average 3 month) | |
| Quality of life measured by the EORTC QLQ C-30 | at the visit for cycle 5 of chemotherapy (at average 3 month) |
| Measure | Description | Time Frame |
|---|---|---|
| Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation | at the visit for cycle 5 of chemotherapy (at average 3 month) | |
| Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiyeon Lee, Ph.D | Contact | 82-2-2228-3255 | jiyeonest@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41946322 | Derived | Hong B, Choi YY, Lee HS, Lee J. Mechanisms underlying the effect of nurse-led enhanced supportive care for advanced cancer patients: A mediation analysis of randomized controlled trial data. Eur J Oncol Nurs. 2026 Jun;82:103186. doi: 10.1016/j.ejon.2026.103186. Epub 2026 Apr 2. | |
| 40378811 | Derived | Choi YY, Hong B, Rha SY, Cho S, Lee HS, Lee J. The effect of nurse-led enhanced supportive care as an early primary palliative care approach for patients with advanced cancer: A randomized controlled trial. Int J Nurs Stud. 2025 Aug;168:105102. doi: 10.1016/j.ijnurstu.2025.105102. Epub 2025 May 1. |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| Control group with usual care | Other | Control group will receive usual care (symptom monitoring only) |
|
| at 6 month |
| Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver | at the visit for cycle 5 of chemotherapy (at average 3 month) |
| Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver | at 6 month |
| Self-efficacy measured by the Cancer Behavior Inventory 3.0 | at the visit for cycle 5 of chemotherapy (at average 3 month) |
| Self-efficacy measured by the Cancer Behavior Inventory 3.0 | at 6 month |
| Survival | at 6 month |
| Survival | at 12 month |
| Symptom measured by the ESAS (Edmonton Symptom Assessment Scale+5 additional symptoms) | at 6 month |
| Coping measured by brief COPE | at 6 month |
| Quality of life measured by the EORTC QLQ C-30 | at 6 month |
| Symptom change measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms): from baseline to 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 | 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) |
| 36461000 | Derived | Choi YY, Rha SY, Cho S, Lee HS, Hong B, Lee J. Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trial. BMC Nurs. 2022 Dec 2;21(1):338. doi: 10.1186/s12912-022-01097-5. |
| D008722 | Methods |