Advanced Cancer
Conditions
Brief summary
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.
Interventions
OTHEREnhanced supportive care based on standardized care pathway
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)
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* adult (age \>=19 years old), * cancer patients and their family * ECOG =\<2
Exclusion criteria
* patients with cognitive or psychiatric issue
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Survival | at 6 month |
| Symptom measured by the ESAS (Edmonton Symptom Assessment Scale+5 additional symptoms) | at 6 month |
| Coping measured by brief COPE | at 6 month |
| Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation | at the visit for cycle 5 of chemotherapy (at average 3 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) |
| Quality of life measured by the EORTC QLQ C-30 | 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) |
| Self-efficacy measured by the Cancer Behavior Inventory 3.0 | at the visit for cycle 5 of chemotherapy (at average 3 month) |
Countries
South Korea
Contacts
Primary ContactJiyeon Lee, Ph.D
Outcome results
None listed