Advanced CancerNCT04407013
Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway
A study testing Enhanced supportive care based on standardized care pathway in people with Advanced Cancer, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Enhanced supportive care based on standardized care pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jun 2020to Feb 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult (age >=19 years old),
- cancer patients and their family
- ECOG =<2
Who cannot join
- patients with cognitive or psychiatric issue
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University
Seoul
Jiyeon Lee, Ph.D, 82-2-2228-3255, jiyeonest@yuhs.ac
About this study
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.
- Conditions
- Advanced Cancer
- Being tested
- Enhanced supportive care based on standardized care pathway, Control group with usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced supportive care based on standardized care pathwayOther
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 careOther
Control group will receive usual care (symptom monitoring only)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Experimental group with application of the standardized care pathways and symptom management education Receives: Other: Enhanced supportive care based on standardized care pathway |
| B | Other | Control group with usual care (symptom monitoring only) Receives: Other: Control group with usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms)
Measured: 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)
Coping measured by brief COPE
Measured: at the visit for cycle 5 of chemotherapy (at average 3 month)
Quality of life measured by the EORTC QLQ C-30
Measured: at the visit for cycle 5 of chemotherapy (at average 3 month)
Secondary outcomes (13)
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation
Measured: at the visit for cycle 5 of chemotherapy (at average 3 month)
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation
Measured: at 6 month
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver
Measured: at the visit for cycle 5 of chemotherapy (at average 3 month)
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver
Measured: at 6 month
Self-efficacy measured by the Cancer Behavior Inventory 3.0
Measured: at the visit for cycle 5 of chemotherapy (at average 3 month)
Self-efficacy measured by the Cancer Behavior Inventory 3.0
Measured: at 6 month
Survival
Measured: at 6 month
Survival
Measured: at 12 month
Symptom measured by the ESAS (Edmonton Symptom Assessment Scale+5 additional symptoms)
Measured: at 6 month
Coping measured by brief COPE
Measured: at 6 month
Quality of life measured by the EORTC QLQ C-30
Measured: at 6 month
Symptom change measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms): from baseline to 3 month
Measured: 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)
Depression change measured by the HADS (Hospital Anxiety and Depression Scale): from baseline to 3 month
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start23 Jun 2020
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advanced 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
- 780 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
- NCT04407013
- Sponsor's protocol ID
- 4-2020-0304
- Status last verified
- Sep 2022
- First submitted
- 18 May 2020
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hong B, Choi YY, Lee HS, Lee J. Mechanisms underlying the effect of nurse-led enhanced supportive care for advanced cancer patients: A mediation analysis of randomized controlled trial data. Eur J Oncol Nurs. 2026 Jun;82:103186. doi: 10.1016/j.ejon.2026.103186. Epub 2026 Apr 2.
PubMed 41946322Choi YY, Hong B, Rha SY, Cho S, Lee HS, Lee J. The effect of nurse-led enhanced supportive care as an early primary palliative care approach for patients with advanced cancer: A randomized controlled trial. Int J Nurs Stud. 2025 Aug;168:105102. doi: 10.1016/j.ijnurstu.2025.105102. Epub 2025 May 1.
PubMed 40378811Choi YY, Rha SY, Cho S, Lee HS, Hong B, Lee J. Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trial. BMC Nurs. 2022 Dec 2;21(1):338. doi: 10.1186/s12912-022-01097-5.
PubMed 36461000
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway
- ClinicalTrials.gov ID
- NCT04407013
- Acronym / sponsor ID
- 4-2020-0304
- Conditions
- Advanced Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 29 May 2020 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Enhanced supportive care based on standardized care pathwayExperimental group with application of the standardized care pathways and symptom management education |
| B | Other | Other: Control group with usual careControl group with usual care (symptom monitoring only) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult (age >=19 years old),
- cancer patients and their family
- ECOG =<2
Key exclusion criteria (1 listed)
- patients with cognitive or psychiatric issue
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 |
|---|---|---|
| Enhanced supportive care based on standardized care pathwayEnhanced 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. | Other | A |
| Control group with usual careControl group will receive usual care (symptom monitoring only) | Other | B |
Primary outcome
Symptom measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms)
Time frame: 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)
Coping measured by brief COPE
Time frame: at the visit for cycle 5 of chemotherapy (at average 3 month)
Quality of life measured by the EORTC QLQ C-30
Time frame: at the visit for cycle 5 of chemotherapy (at average 3 month)
13 secondary outcomes
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation
Time frame: at the visit for cycle 5 of chemotherapy (at average 3 month)
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation
Time frame: at 6 month
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver
Time frame: at the visit for cycle 5 of chemotherapy (at average 3 month)
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver
Time frame: at 6 month
Self-efficacy measured by the Cancer Behavior Inventory 3.0
Time frame: at the visit for cycle 5 of chemotherapy (at average 3 month)
Self-efficacy measured by the Cancer Behavior Inventory 3.0
Time frame: at 6 month
Survival
Time frame: at 6 month
Survival
Time frame: at 12 month
Symptom measured by the ESAS (Edmonton Symptom Assessment Scale+5 additional symptoms)
Time frame: at 6 month
Coping measured by brief COPE
Time frame: at 6 month
Quality of life measured by the EORTC QLQ C-30
Time frame: at 6 month
Symptom change measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms): from baseline to 3 month
Time frame: 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)
Depression change measured by the HADS (Hospital Anxiety and Depression Scale): from baseline to 3 month
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Derived from this study: PubMed 41946322Hong B, Choi YY, Lee HS, Lee J. Mechanisms underlying the effect of nurse-led enhanced supportive care for advanced cancer patients: A mediation analysis of randomized controlled trial data. Eur J Oncol Nurs. 2026 Jun;82:103186. doi: 10.1016/j.ejon.2026.103186. Epub 2026 Apr 2.
- Derived from this study: PubMed 40378811Choi YY, Hong B, Rha SY, Cho S, Lee HS, Lee J. The effect of nurse-led enhanced supportive care as an early primary palliative care approach for patients with advanced cancer: A randomized controlled trial. Int J Nurs Stud. 2025 Aug;168:105102. doi: 10.1016/j.ijnurstu.2025.105102. Epub 2025 May 1.
- Derived from this study: PubMed 36461000Choi YY, Rha SY, Cho S, Lee HS, Hong B, Lee J. Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trial. BMC Nurs. 2022 Dec 2;21(1):338. doi: 10.1186/s12912-022-01097-5.
- 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 Enhanced supportive care based on standardized care pathway in people with Advanced 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 1 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 10 Sep 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 Jiyeon Lee, Ph.D (82-2-2228-3255, jiyeonest@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms) (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04407013, which also lists 3 linked publications.
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 10 Sep 2022.