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

Not Applicable

Recruiting

• Conditions: Lung Cancer - Non Small Cell; Lung Cancer (NSCLC)
• Interventions: Other: Early palliative care integration; Drug: Standard systemic treatment for advanced lung cancer

• Registration Number: NCT06786468
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study Start: 2024-04-02
• Status Verified: 2025-01
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Study First Posted: 2025-01-22
• Last Update Posted: 2025-01-22
• Primary Completion: 2026-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early palliative care with standard care	Early palliative care integration	The patients will attend palliative care clinic once a month during the first three months together with oncology clinic visits
Early palliative care with standard care	Standard systemic treatment for advanced lung cancer	The patients will attend palliative care clinic once a month during the first three months together with oncology clinic visits
Standard care	Standard systemic treatment for advanced lung cancer	The patients will attend oncology clinic as usual

Primary Outcome Measures

Name	Time	Method
Quality of life score (FACT-L Total Score)	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 Outcome Measures

Name	Time	Method
Change in quality of life (FACT-L Total Scores)	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.
Change in mental health score (PHQ-9)	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.
Change in pain score	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.
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

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand