Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway
NCT ID: NCT04407013
Last Updated: 2022-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
780 participants
INTERVENTIONAL
2020-06-23
2024-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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A
Experimental group with application of the standardized care pathways and symptom management education
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.
B
Control group with usual care (symptom monitoring only)
Control group with usual care
Control group will receive usual care (symptom monitoring only)
Interventions
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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.
Control group with usual care
Control group will receive usual care (symptom monitoring only)
Eligibility Criteria
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Inclusion Criteria
* cancer patients and their family
* ECOG =\<2
Exclusion Criteria
19 Years
ALL
Yes
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Yonsei University
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Choi YY, Hong B, Rha SY, Cho S, Lee HS, Lee J. The effect of nurse-led enhanced supportive care as an early primary palliative care approach for patients with advanced cancer: A randomized controlled trial. Int J Nurs Stud. 2025 Aug;168:105102. doi: 10.1016/j.ijnurstu.2025.105102. Epub 2025 May 1.
Choi YY, Rha SY, Cho S, Lee HS, Hong B, Lee J. Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trial. BMC Nurs. 2022 Dec 2;21(1):338. doi: 10.1186/s12912-022-01097-5.
Other Identifiers
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4-2020-0304
Identifier Type: -
Identifier Source: org_study_id
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