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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
780
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.
Control group will receive usual care (symptom monitoring only)
Yonsei University
Seoul, South Korea
RECRUITINGSymptom measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms)
Time frame: 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
Time frame: at the visit for cycle 5 of chemotherapy (at average 3 month)
Quality of life measured by the EORTC QLQ C-30
Time frame: at the visit for cycle 5 of chemotherapy (at average 3 month)
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation
Time frame: at the visit for cycle 5 of chemotherapy (at average 3 month)
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation
Time frame: at 6 month
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver
Time frame: at the visit for cycle 5 of chemotherapy (at average 3 month)
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver
Time frame: at 6 month
Self-efficacy measured by the Cancer Behavior Inventory 3.0
Time frame: at the visit for cycle 5 of chemotherapy (at average 3 month)
Self-efficacy measured by the Cancer Behavior Inventory 3.0
Time frame: at 6 month
Survival
Time frame: at 6 month
Survival
Time frame: at 12 month
Symptom measured by the ESAS (Edmonton Symptom Assessment Scale+5 additional symptoms)
Time frame: at 6 month
Coping measured by brief COPE
Time frame: at 6 month
Quality of life measured by the EORTC QLQ C-30
Time frame: at 6 month
Symptom change measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms): from baseline to 3 month
Time frame: 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
Time frame: 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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