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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Other: Enhanced supportive care based on standardized care pathway; Other: Control group with usual care

• Study Type: Interventional
• Enrollment (Anticipated): 780
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiyeon Lee, Ph.D; Phone Number: 82-2-2228-3255; Email: jiyeonest@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei University
    • Contact: Jiyeon Lee, Ph.D; Phone Number: 82-2-2228-3255; Email: jiyeonest@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• patients with cognitive or psychiatric issue

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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 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
Symptom measured by the ESAS (Edmonton Symptom Assessment Scale+5 additional symptoms)	at 6 month
Coping measured by brief COPE	at 6 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)
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)

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 24, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 4-2020-0304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No