Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: A Experimental group with application of the standardized care pathways and symptom management education |
Other: Enhanced 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.
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Other: B Control group with usual care (symptom monitoring only) |
Other: Control group with usual care
Control group will receive usual care (symptom monitoring only)
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Outcome Measures
Primary Outcome Measures
- Symptom measured by the ESAS (Edmonton Symptom Assessment Scale) [at Baseline (before start of chemotherapy)]
- Symptom measured by the ESAS (Edmonton Symptom Assessment Scale) [At the beginning of Cycle 2 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)]
- Symptom measured by the ESAS (Edmonton Symptom Assessment Scale) [At the beginning of Cycle 3 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)]
- Symptom measured by the ESAS (Edmonton Symptom Assessment Scale) [At the beginning of Cycle 4 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)]
- Symptom measured by the ESAS (Edmonton Symptom Assessment Scale) [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)]
- Symptom measured by the ESAS (Edmonton Symptom Assessment Scale) [at 6 month]
- Coping measured by brief COPE [Baseline (at enrollment)]
- Coping measured by brief COPE [at the visit for cycle 5 of chemotherapy (at average 3 month)]
- Coping measured by brief COPE [at 6 month]
- Quality of life measured by the EORTC QLQ C-30 [Baseline (at enrollment)]
- Quality of life measured by the EORTC QLQ C-30 [at the visit for cycle 5 of chemotherapy (at average 3 month)]
- Quality of life measured by the EORTC QLQ C-30 [at 6 month]
Secondary Outcome Measures
- Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation [at Baseline (before start of chemotherapy)]
- Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation [At the beginning of Cycle 2 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)]
- Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation [At the beginning of Cycle 3 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)]
- Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation [At the beginning of Cycle 4 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)]
- 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 Baseline (before start of chemotherapy)]
- 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 Baseline (before start of chemotherapy)]
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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adult (age >=19 years old),
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cancer patients and their family
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ECOG =<2
Exclusion Criteria:
- patients with cognitive or psychiatric issue
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Yonsei University | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Yonsei University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4-2020-0304