Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05584592 |
| Other study ID # |
4-2020-0636 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2020 |
| Est. completion date |
February 2023 |
Study information
| Verified date |
October 2022 |
| Source |
Yonsei University |
| Contact |
Minkyu Jung |
| Phone |
82-2-2228-8129 |
| Email |
minkjung[@]yuhs.ac |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
- Recruitment of research subjects: Outpatients and inpatients who meet the criteria for
research are explained about the research and recruited, and written consent is
obtained.
- Random assignment: The intervention group and the control group will be assigned 1:1,
and whether the recruited patients are HER2-positive (positive vs negative), systemic
activity (ECOG 0-1 vs 2), anticancer order [1st line vs 2nd] line (1st chemotherapy PFS
of more than 6 months in case of 2nd line vs. PFS of primary chemotherapy less than 6
months in case of 2nd line) was randomized as a stratification factor.
- Intervention group (integrated early palliative care): While receiving standard
chemotherapy, with the first meeting with the palliative care team within 4 weeks of
randomization, and during the course of treatment regularly, once every 3 weeks (± 1
week) for 12 weeks Provides advance care planning, symptom control, and palliative care
for other mental, social and spiritual problems. In the baseline survey, information
about the Eul palliative care center is provided.
- Control group (standard chemotherapy group): Allows patients to receive conventional
palliative care when they want or need it by medical staff. In other words, if a patient
assigned to a control group desires palliative care, they can receive conventional
palliative care.
- Data collection: The first questionnaire was conducted at the time of registration of
the study subjects, the follow-up questionnaire was conducted at about 12 weeks, and
survival was investigated after 1 year. The first questionnaire and follow-up
questionnaire surveyed quality of life (EORTC QLQ-C30, EORTC QOL-ST022) and emotional
disorder (HADS-D/A)
?Data Management: Keeping the completed subject questionnaire and recording the case
record.
- Outcome indicators: The primary outcome indicators are evaluated as changes in the
patient's comprehensive quality of life (Trial Outcome Index=EORTC QLQ-C30 + EORTC
QOL-ST022) at the time of enrollment and 12 weeks of follow-up. , anticancer side
effects, survival period, and changes in skeletal muscle mass index as secondary outcome
indicators
