Lung Cancer - Non Small CellNCT06786468
Standard Care With or Without Early Palliative Care Provided by Palliative Care Specialist in Advanced Non-small Cell Lung Cancer Patients
A study testing Early palliative care integration and Standard systemic treatment for advanced lung cancer in people with Lung Cancer - Non Small Cell and Lung Cancer (NSCLC), run by Mahidol University at 1 site in Thailand.
Trial summary
Early palliative care has been shown to improve the survival of advanced lung cancer patients. However, most of the clinical studies were performed in the era when systemic treatment options for this disease were limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer - Non Small Cell, Lung Cancer (NSCLC)
- What is being tested?
- Early palliative care integration and Standard systemic treatment for advanced lung cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteThailand
- Study dates
- 2 Apr 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 18 years old
- Pathologically confirmed advanced non-small cell lung cancer
- Plan to receive systemic treatment for lung cancer within three weeks
- ECOG performance status 0-2 with estimated life expectancy > 24 weeks
- Having at least 4 scores according to Edmonton Symptom Assessment System (ESAS)
- Able to complete the questionnaires
Who cannot join
- Had received systemic treatment for advanced lung cancer before
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital
Bangkok, 10700
Lucksamon Thamlikitkul, MD, PhD, +6624194489, lucksamon.tha@mahidol.edu
Lucksamon Thamlikitkul, MD, PhD
About this study
Official title: Randomized Controlled Trial of Standard Care With or Without Early Palliative Care Provided by Palliative Care Specialist in Advanced Non-small Cell Lung Cancer Patients
Early palliative care has been shown to improve the survival of advanced lung cancer patients. However, most of the clinical studies were performed in the era when systemic treatment options for this disease were limited. Currently, many effective treatment options are available, including targeted therapy and immunotherapy. These novel agents improve the treatment outcomes while having less toxicity compared to conventional chemotherapy. Moreover, medical oncologists are now trained to provide palliative care for patients. This study was designed to demonstrate whether early palliative care provided by the palliative care specialist still improves the quality of life or survival of advanced lung cancer patients compared to standard care provided by the medical oncologist.
Read the detailed description
Advanced non-small cell lung cancer patients initiating a systemic treatment will be randomized to the early palliative care arm (attending a palliative care clinic once a month during the first three months concurrently with oncology clinic appointment) or the standard care arm (attending oncology clinic only). The patients will be asked to complete the quality of life questionnaires (FACT-L, EQ-5D-5L), mental health questionnaire (PHQ-9), and pain assessment once a month for three months and at the sixth month.
- Conditions
- Lung Cancer - Non Small Cell, Lung Cancer (NSCLC)
- Being tested
- Early palliative care integration, Standard systemic treatment for advanced lung cancer
- Keywords
- early palliative care, palliative care, lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early palliative care integrationOther
The patients will attend palliative care clinic once a month during the first three months together with routine oncology clinic visits
Standard systemic treatment for advanced lung cancerDrug
Standard systemic treatment for advanced lung cancer
| Study group | Role | What they receive |
|---|---|---|
| Early palliative care with standard care | Experimental | The patients will attend palliative care clinic once a month during the first three months together with oncology clinic visits Receives: Other: Early palliative care integration; Drug: Standard systemic treatment for advanced lung cancer |
| Standard care | Active comparator | The patients will attend oncology clinic as usual Receives: Drug: Standard systemic treatment for advanced lung cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life score (FACT-L Total Score)
The patients were asked to assess their Health-related Quality Of Life (HRQoL) using FACT-L (Functional Assessment of Cancer Therapy - Lung) questionnaire. The score ranges from 0-136 with higher score indicating better HRQoL.
Measured: 12 weeks after treatment
Secondary outcomes (7)
Change in quality of life (FACT-L Total Scores)
The patients were asked to assess their Health-related Quality Of Life (HRQoL) using FACT-L (Functional Assessment of Cancer Therapy - Lung) questionnaire. The score ranges from 0-136 with higher score indicating better HRQoL. Change in FACT-L Total Scores defined as the difference between FACT-L Total Score at a specified time point minus baseline FACT-L Total Score.
Measured: 12 and 24 weeks after treatment
Change in mental health score (PHQ-9)
The patients were asked to assess their depression levels using a Patient Health Questionnaire 9 (PHQ-9). The score ranges from 0-27 with 0 indicating no depression and 27 indicating severe depression.
Measured: 12 and 24 weeks after treatment
Change in pain score
The patients were asked to assess their pain using a Numerical Rating Scale (NRS). The score ranges from 0-10 with 0 indicating no pain and 10 indicating worst pain imaginable.
Measured: 12 and 24 weeks after treatment
One-year survival rate
Measured: One year after treatment
Two-year survival rate
Measured: Two years after treatment
Proportion of patients who have advanced care plan
Measured: six months
Change in utility score measured by EQ-5D-5L questionnaire
Measured: 12 and 24 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start2 Apr 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer - Non Small CellStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucksamon Thamlikitkul, MD, PhD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786468
- Sponsor's protocol ID
- 068/2567(IRB3)
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 22 Jan 2025
- 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 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Standard Care With or Without Early Palliative Care Provided by Palliative Care Specialist in Advanced Non-small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT06786468
- Acronym / sponsor ID
- 068/2567(IRB3)
- Conditions
- Lung Cancer - Non Small Cell, Lung Cancer (NSCLC)
- Keywords
- early palliative care, palliative care, lung cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 22 Jan 2025 (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.
Early palliative care has been shown to improve the survival of advanced lung cancer patients. However, most of the clinical studies were performed in the era when systemic treatment options for this disease were limited. Currently, many effective treatment options are available, including targeted therapy and immunotherapy. These novel agents improve the treatment outcomes while having less toxicity compared to conventional chemotherapy. Moreover, medical oncologists are now trained to provide palliative care for patients. This study was designed to demonstrate whether early palliative care provided by the palliative care specialist still improves the quality of life or survival of advanced lung cancer patients compared to standard care provided by the medical oncologist.
Detailed description
Advanced non-small cell lung cancer patients initiating a systemic treatment will be randomized to the early palliative care arm (attending a palliative care clinic once a month during the first three months concurrently with oncology clinic appointment) or the standard care arm (attending oncology clinic only). The patients will be asked to complete the quality of life questionnaires (FACT-L, EQ-5D-5L), mental health questionnaire (PHQ-9), and pain assessment once a month for three months and at the sixth month.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early palliative care with standard care | Experimental | Other: Early palliative care integration, Drug: Standard systemic treatment for advanced lung cancerThe patients will attend palliative care clinic once a month during the first three months together with oncology clinic visits |
| Standard care | Active comparator | Drug: Standard systemic treatment for advanced lung cancerThe patients will attend oncology clinic as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age at least 18 years old
- Pathologically confirmed advanced non-small cell lung cancer
- Plan to receive systemic treatment for lung cancer within three weeks
- ECOG performance status 0-2 with estimated life expectancy > 24 weeks
- Having at least 4 scores according to Edmonton Symptom Assessment System (ESAS)
Key exclusion criteria (1 listed)
- Had received systemic treatment for advanced lung cancer before
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 |
|---|---|---|
| Early palliative care integrationThe patients will attend palliative care clinic once a month during the first three months together with routine oncology clinic visits | Other | Early palliative care with standard care |
| Standard systemic treatment for advanced lung cancerStandard systemic treatment for advanced lung cancer | Drug | Early palliative care with standard care, Standard care |
Primary outcome
Quality of life score (FACT-L Total Score)
Time frame: 12 weeks after treatment
The patients were asked to assess their Health-related Quality Of Life (HRQoL) using FACT-L (Functional Assessment of Cancer Therapy - Lung) questionnaire. The score ranges from 0-136 with higher score indicating better HRQoL.
7 secondary outcomes
Change in quality of life (FACT-L Total Scores)
Time frame: 12 and 24 weeks after treatment
Change in mental health score (PHQ-9)
Time frame: 12 and 24 weeks after treatment
Change in pain score
Time frame: 12 and 24 weeks after treatment
One-year survival rate
Time frame: One year after treatment
Two-year survival rate
Time frame: Two years after treatment
Proportion of patients who have advanced care plan
Time frame: six months
Change in utility score measured by EQ-5D-5L questionnaire
Time frame: 12 and 24 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- 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.
Lucksamon Thamlikitkul, MD, PhD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early palliative care integration and Standard systemic treatment for advanced lung cancer in people with Lung Cancer - Non Small Cell and Lung Cancer (NSCLC), run by Mahidol University at 1 site in Thailand.
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 6 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: looking for participants now, as of the sponsor's last update on 22 Jan 2025. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucksamon Thamlikitkul, MD, PhD (+6624194489, lucksamon.tha@mahidol.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life score (FACT-L Total Score) (time frame: 12 weeks after treatment). 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 22 Jan 2025.