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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Standard care | Active Comparator | The patients will attend oncology clinic as usual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early palliative care integration | Other | The patients will attend palliative care clinic once a month during the first three months together with routine oncology clinic visits |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucksamon Thamlikitkul, MD, PhD | Contact | +6624194489 | lucksamon.tha@mahidol.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lucksamon Thamlikitkul, MD, PhD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Recruiting | Bangkok | 10700 | Thailand |
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| Standard systemic treatment for advanced lung cancer | Drug | Standard systemic treatment for advanced lung cancer |
|
| 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. | 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. | 12 and 24 weeks after treatment |
| One-year survival rate | One year after treatment |
| Two-year survival rate | Two years after treatment |
| Proportion of patients who have advanced care plan | six months |
| Change in utility score measured by EQ-5D-5L questionnaire | 12 and 24 weeks after treatment |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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