Advanced Gastric CancerNCT05584592
A Randomized Controlled Trial of Integrated Early Palliative Care for Advanced Gastric Cancer Patients
A study testing Intergrate early palliatuve care + Conventional chemotherapy and Conventional chemotherapy in people with Advanced Gastric Cancer, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- Intergrate early palliatuve care + Conventional chemotherapy and Conventional chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2020to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 4. Those who are planning to undergo 1st or 2nd palliative chemotherapy 5. Those who wish to participate in the research
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei Cancer Center, Yonsei University College of Medicine
Seoul
Minkyu Jung, 82-2-2228-8129, minkjung@yuhs.ac
About this study
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.
Read the detailed 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
- Conditions
- Advanced Gastric Cancer
- Being tested
- Intergrate early palliatuve care + Conventional chemotherapy, Conventional chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intergrate early palliatuve care + Conventional chemotherapyOther
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.
Conventional chemotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intergrate early palliatuve care + Conventional chemotherapy | Experimental | Not described Receives: Other: Intergrate early palliatuve care + Conventional chemotherapy |
| Conventional chemotherapy | Active comparator | Not described Receives: Other: Conventional chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
Enotional disorders(HASA-D/A)
Both the intervention group and the control group are evaluated by Questionnaire evaluation tool (HADS-D/A) .
Measured: 2 years
Objective Response Rate (ORR)
Objective response rate is defined as the number of patients with at least one confirmed visit response of CR or PR.
Measured: 2 years
Progression-Free Survival (PFS)
To evaluate the treatment effect of Integrated Early Palliative Care group vs standard chemotherapy group on progression-free survival (PFS) rate.
Measured: 2 years
Overall Survival (OS)
The time from the date of first dose and the date of death from any cause.
Measured: 2 years
Skeletal muscle mass index (Skeletal muscle mass index, SMI) changes
Both the intervention group and the control group are evaluated by measuring skeletal muscle mass index (SMI) through Inbody®
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Jul 2020
- Primary completionNov 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584592
- Sponsor's protocol ID
- 4-2020-0636
- Status last verified
- Oct 2022
- First submitted
- 14 Oct 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Integrated Early Palliative Care for Advanced Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT05584592
- Acronym / sponsor ID
- 4-2020-0636
- Conditions
- Advanced Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intergrate early palliatuve care + Conventional chemotherapy | Experimental | Other: Intergrate early palliatuve care + Conventional chemotherapy |
| Conventional chemotherapy | Active comparator | Other: Conventional chemotherapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- 4. Those who are planning to undergo 1st or 2nd palliative chemotherapy 5. Those who wish to participate in the research
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intergrate early palliatuve care + Conventional chemotherapySixty 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 | Intergrate early palliatuve care + Conventional chemotherapy |
| Conventional chemotherapypatients 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. | Other | Conventional chemotherapy |
Primary outcome
Changes in patient's comprehensive quality of life composite
Time frame: 12 weeks
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.
5 secondary outcomes
Enotional disorders(HASA-D/A)
Time frame: 2 years
Objective Response Rate (ORR)
Time frame: 2 years
Progression-Free Survival (PFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Skeletal muscle mass index (Skeletal muscle mass index, SMI) changes
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intergrate early palliatuve care + Conventional chemotherapy and Conventional chemotherapy in people with Advanced Gastric Cancer, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minkyu Jung (82-2-2228-8129, minkjung@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in patient's comprehensive quality of life composite (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.