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

NCT04407013 | Unknown DMC

• 1 other identifier: 4-2020-0304
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• 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)

Study Arms (2)

A

EXPERIMENTAL

Experimental group with application of the standardized care pathways and symptom management education

Other: Enhanced supportive care based on standardized care pathway

B

OTHER

Control group with usual care (symptom monitoring only)

Other: Control group with usual care

Interventions

Enhanced supportive care based on standardized care pathway OTHER

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.

A

Control group with usual care OTHER

Control group will receive usual care (symptom monitoring only)

B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients with cognitive or psychiatric issue

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University

Seoul, South Korea

RECRUITING

Related Publications (2)

• 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.

  PMID: 40378811 DERIVED

• 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.

  PMID: 36461000 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Jiyeon Lee, Ph.D

CONTACT

82-2-2228-3255; jiyeonest@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 29, 2020
• Study Start: June 23, 2020
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)