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

NCT05584592 | Unknown

• 1 other identifier: 4-2020-0636
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Changes in patient's comprehensive quality of life composite

  Changes in patient's comprehensive quality of life (Trial Outcome Index=EORTC QLQ-C30 + EORTC QOL-ST022) at enrollment and 12-week follow-up The primary endpoint of this study was the change in the patient's comprehensive quality of life (Trial Outcome Index=EORTC QLQ-C30 + EORTC QOL-ST022) compared to the baseline outcome at week 12. The amount of change in the results at 12 weeks compared to the baseline result of the comprehensive quality of life (TOI) will be estimated in each group, and the effect size will be estimated for the difference in the amount of change between the two groups.

  12 weeks

Secondary Outcomes (5)

• Enotional disorders(HASA-D/A)

  2 years

• Objective Response Rate (ORR)

  2 years

• Progression-Free Survival (PFS)

  2 years

• Overall Survival (OS)

  2 years

• Skeletal muscle mass index (Skeletal muscle mass index, SMI) changes

  2 years

Study Arms (2)

Intergrate early palliatuve care + Conventional chemotherapy

EXPERIMENTAL

Other: Intergrate early palliatuve care + Conventional chemotherapy

Conventional chemotherapy

ACTIVE COMPARATOR

Other: Conventional chemotherapy

Interventions

Intergrate early palliatuve care + Conventional chemotherapy OTHER

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.

Intergrate early palliatuve care + Conventional chemotherapy

Conventional chemotherapy OTHER

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.

Conventional chemotherapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a histologically or cytologically advanced gastric cancer patients
• Those who are 19 years of age or older 3. Those who belong to ECOG performance status 0\~2
• \. Those who are planning to undergo 1st or 2nd palliative chemotherapy 5. Those who wish to participate in the research

You may not qualify if:

• Those who are judged by the doctor to be unable to conduct this investigation due to medically poor health conditions (shortness of breath, etc.)
• Those who have previously received palliative care or are receiving palliative care

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Cancer Center, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

Central Study Contacts

Minkyu Jung

CONTACT

82-2-2228-8129; minkjung@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: October 14, 2022
• First Posted: October 18, 2022
• Study Start: July 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: February 1, 2023
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)