MedTrace Logo

A Randomized Controlled Trial of Integrated Early Palliative Care for Advanced Gastric Cancer Patients

NCT05584592 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2022-10-18

No results posted yet for this study

Summary

Cancer patients and their families constantly face physical, psychosocial, economic, and existential problems, but palliative care to solve and prevent them is currently applied only at a late stage in Korean medical practice, which and has many limitations in solving practical difficulties. In order to solve the physical, mental, social, and spiritual health problems experienced by cancer patients in a situation where the cancer incidence rate is increasing every year, the timing and standard of providing palliative care in consideration of the current medical reality and the current status of chemotherapy There is an urgent need for research on a valid medical basis for a new Korean-style early palliative care program.

Early palliative care intervention study in patients with advanced cancer (Zimmermann et al, Lancet, 2014) and comparative study of early versus delayed palliative care intervention in patients with advanced cancer \[Project ENABLE III\] (Bakitas et al, JCO, 2015) The study started the intervention immediately after diagnosis of advanced or metastatic cancer. This is done earlier than traditional hospice palliative care, and provides professional services to not only proactively manage symptoms and improve quality of life, but also identify and implement the preferences, values, goals, and needs of patients and families. Although there are studies on the effect of early palliative care in multicenters for patients with locally advanced/metastatic gastric cancer, in the case of studies conducted at multicenters, there is no way to standardize the quality of palliative care at each research institute, so the intervention group is passive treatment. In many cases, it is difficult to obtain homogeneous results when the control group is cross-mixed with the intervention group. Thus, several factors are well-controlled and systematically Through this study, it is necessary to verify the effect of early palliative care in patients with gastric cancer, which occurs the most every year in Koreans.

About 170 patients with advanced gastric cancer who were histologically or cytologically diagnosed with gastric cancer at the participating institution are targeted. About 170 recruited patients will be randomly assigned to two groups, the intervention group and the control group.

Conditions

  • Advanced Gastric Cancer

Interventions

OTHER

Intergrate early palliatuve care + Conventional chemotherapy

Sixty patients with gastric and pancreatic cancer will be eligible, and 30 patients will be randomly assigned to the exercise therapy + high protein supplement group and 30 patients to the exercise therapy + placebo supplement group.

OTHER

Conventional chemotherapy

patients to receive routine palliative care when they want it or when it is needed by health care providers. In other words, if a patient assigned to the control group desires palliative care, they can receive conventional palliative care.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-11-30
Completion
2023-02-28

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05584592 on ClinicalTrials.gov