Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced Cancer
- Sponsor
- Yonsei University
- Enrollment
- 780
- Locations
- 1
- Primary Endpoint
- Quality of life measured by the EORTC QLQ C-30
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •adult (age \>=19 years old),
- •cancer patients and their family
- •ECOG =\<2
Exclusion Criteria
- •patients with cognitive or psychiatric issue
Outcomes
Primary Outcomes
Quality of life measured by the EORTC QLQ C-30
Time Frame: at the visit for cycle 5 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)
Symptom 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)
Secondary Outcomes
- Self-efficacy measured by the Cancer Behavior Inventory 3.0(at 6 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 6 month)
- Coping measured by brief COPE(at 6 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))
- Survival(at 12 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))
- Symptom measured by the ESAS (Edmonton Symptom Assessment Scale+5 additional symptoms)(at 6 month)