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NCT Number: NCT06786468

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.

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Key information

Conditions

Lung Cancer - Non Small Cell Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Cancer (NSCLC) Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siriraj Hospital

Bangkok, 10700, Thailand

Location status: Recruiting

Location contact

Lucksamon Thamlikitkul, MD, PhD

CONTACT

[email protected]

+6624194489

Lucksamon Thamlikitkul, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Standard systemic treatment for advanced lung cancer

Drug

Standard systemic treatment for advanced lung cancer

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in quality of life (FACT-L Total Scores)

    Time frame: 12 and 24 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. 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.

  2. Change in mental health score (PHQ-9)

    Time frame: 12 and 24 weeks after treatment

    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.

  3. Change in pain score

    Time frame: 12 and 24 weeks after treatment

    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.

  4. One-year survival rate

    Time frame: One year after treatment

  5. Two-year survival rate

    Time frame: Two years after treatment

  6. Proportion of patients who have advanced care plan

    Time frame: six months

  7. Change in utility score measured by EQ-5D-5L questionnaire

    Time frame: 12 and 24 weeks after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Lucksamon Thamlikitkul, MD, PhD

CONTACT

[email protected]

+6624194489

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 22, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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