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

Study Overview
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Brief Summary
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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.

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

Conditions
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Advanced Cancer

Intervention / Treatment
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* Other: Enhanced supportive care based on standardized care pathway
* Other: Control group with usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult (age >=19 years old), cancer patients and their family ECOG =<2 Exclusion Criteria: patients with cognitive or psychiatric issue

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Experimental group with application of the standardized care pathways and symptom management education | Other: Enhanced supportive care based on standardized care pathway<br>* 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.<br>|
| Other: B<br>Control group with usual care (symptom monitoring only) | Other: Control group with usual care<br>* Control group will receive usual care (symptom monitoring only)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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) |