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

Not Applicable

Recruiting

• Conditions: Advanced Cancer
• Interventions: Other: Control group with usual care; Other: Enhanced supportive care based on standardized care pathway

• Registration Number: NCT04407013
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-24
• Study First Posted: 2020-05-29
• Study Start: 2020-06-23
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-10
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 780

Inclusion Criteria

• adult (age >=19 years old),
• cancer patients and their family
• ECOG =<2

Exclusion Criteria

• patients with cognitive or psychiatric issue

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Control group with usual care	Control group with usual care (symptom monitoring only)
A	Enhanced supportive care based on standardized care pathway	Experimental group with application of the standardized care pathways and symptom management education

Primary Outcome Measures

Name	Time	Method
Quality of life measured by the EORTC QLQ C-30	at the visit for cycle 5 of chemotherapy (at average 3 month)
Coping measured by brief COPE	at the visit for cycle 5 of chemotherapy (at average 3 month)
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)

Secondary Outcome Measures

Name	Time	Method
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver	at 6 month
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation	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)
Self-efficacy measured by the Cancer Behavior Inventory 3.0	at 6 month
Symptom measured by the ESAS (Edmonton Symptom Assessment Scale+5 additional symptoms)	at 6 month

Trial Locations

Locations (1)

Yonsei University; 🇰🇷 Seoul, Korea, Republic of