NCT04407013

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 780 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
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.
OTHER	Control group with usual care	Control group will receive usual care (symptom monitoring only)

Timeline

• Start date: 2020-06-23
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2020-05-29
• Last updated: 2022-09-10

Locations

1 site across 1 country: South Korea