Clinical trial NCT06786468: Standard Care With or Without Early Palliative Care Provided by Palliative Care Specialist in Advanced Non-small Cell Lung Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer - Non Small Cell
Lung Cancer (NSCLC)
Keywords: early palliative care
palliative care
lung cancer
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Had received systemic treatment for advanced lung cancer before

Primary outcomes:
measure: Quality of life score (FACT-L Total Score)
timeFrame: 12 weeks after treatment
Secondary outcomes:
measure: Change in quality of life (FACT-L Total Scores)
timeFrame: 12 and 24 weeks after treatment
measure: Change in mental health score (PHQ-9)
timeFrame: 12 and 24 weeks after treatment
measure: Change in pain score
timeFrame: 12 and 24 weeks after treatment
measure: One-year survival rate
timeFrame: One year after treatment
measure: Two-year survival rate
timeFrame: Two years after treatment
measure: Proportion of patients who have advanced care plan
timeFrame: six months
measure: Change in utility score measured by EQ-5D-5L questionnaire
timeFrame: 12 and 24 weeks after treatment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Lucksamon Thamlikitkul, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: