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Recruiting NCT06786468

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

No phase Interventional Lung Cancer - Non Small Cell Lung Cancer (NSCLC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early palliative care integration, Standard systemic treatment for advanced lung cancer.
Who it may be relevant to
Registry conditions: Lung Cancer - Non Small Cell, Lung Cancer (NSCLC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Other Early palliative care integration
    The patients will attend palliative care clinic once a month during the first three months together with routine oncology clinic visits
  • Drug Standard systemic treatment for advanced lung cancer
    Standard systemic treatment for advanced lung cancer

Primary outcome measures

  • Quality of life score (FACT-L Total Score) [Time frame: 12 weeks after treatment]
Secondary outcome measures (7)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Thailand · 1 center
  • Siriraj Hospital — Bangkok

Identifiers

NCT: NCT06786468 · 068/2567(IRB3)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗