Standard Care With or Without Early Palliative Care Provided by Palliative Care Specialist in Advanced Non-small Cell Lung Cancer Patients

Mahidol University

Status: Enrolling

Conditions: Lung Cancer (NSCLC); Lung Cancer - Non Small Cell

Treatments: Drug: Standard systemic treatment for advanced lung cancer; Other: Early palliative care integration

Study type: Interventional

Funder types: Other

Identifiers

NCT06786468

068/2567(IRB3)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Early palliative care with standard care

Experimental group

Description:

The patients will attend palliative care clinic once a month during the first three months together with oncology clinic visits

Treatment:

Drug: Standard systemic treatment for advanced lung cancer

Other: Early palliative care integration

Standard care

Active Comparator group

Description:

The patients will attend oncology clinic as usual

Treatment:

Drug: Standard systemic treatment for advanced lung cancer