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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04407013
• Other study ID #: 4-2020-0304
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2020
• Est. completion date: February 2024

Study information

• Verified date: September 2022
• Source: Yonsei University
• Contact: Jiyeon Lee, Ph.D
• Phone: 82-2-2228-3255
• Email: jiyeonest[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 780
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• adult (age >=19 years old),

• cancer patients and their family

• ECOG =<2

Exclusion Criteria:

• patients with cognitive or psychiatric issue

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

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.
• Control group with usual care
Control group will receive usual care (symptom monitoring only)

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Coping measured by brief COPE		at the visit for cycle 5 of chemotherapy (at average 3 month)
Primary	Quality of life measured by the EORTC QLQ C-30		at the visit for cycle 5 of chemotherapy (at average 3 month)
Secondary	Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation		at the visit for cycle 5 of chemotherapy (at average 3 month)
Secondary	Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation		at 6 month
Secondary	Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver		at the visit for cycle 5 of chemotherapy (at average 3 month)
Secondary	Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver		at 6 month
Secondary	Self-efficacy measured by the Cancer Behavior Inventory 3.0		at the visit for cycle 5 of chemotherapy (at average 3 month)
Secondary	Self-efficacy measured by the Cancer Behavior Inventory 3.0		at 6 month
Secondary	Survival		at 6 month
Secondary	Survival		at 12 month
Secondary	Symptom measured by the ESAS (Edmonton Symptom Assessment Scale+5 additional symptoms)		at 6 month
Secondary	Coping measured by brief COPE		at 6 month
Secondary	Quality of life measured by the EORTC QLQ C-30		at 6 month
Secondary	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)
Secondary	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)