NCT06786468

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Apr 2024Apr 2027

Study Start

First participant enrolled

April 2, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

January 6, 2025

Last Update Submit

January 20, 2025

Conditions

Lung Cancer - Non Small CellLung Cancer (NSCLC)

Keywords

early palliative carepalliative carelung cancer

Outcome Measures

Primary Outcomes (1)

  • Quality of life score (FACT-L Total Score)

    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.

    12 weeks after treatment

Secondary Outcomes (7)

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

    12 and 24 weeks after treatment

  • Change in mental health score (PHQ-9)

    12 and 24 weeks after treatment

  • Change in pain score

    12 and 24 weeks after treatment

  • One-year survival rate

    One year after treatment

  • Two-year survival rate

    Two years after treatment

  • +2 more secondary outcomes

Study Arms (2)

Early palliative care with standard care

EXPERIMENTAL

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

Other: Early palliative care integrationDrug: Standard systemic treatment for advanced lung cancer

Standard care

ACTIVE COMPARATOR

The patients will attend oncology clinic as usual

Drug: Standard systemic treatment for advanced lung cancer

Interventions

Early palliative care integrationOTHER

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

Early palliative care with standard care
Standard systemic treatment for advanced lung cancerDRUG

Standard systemic treatment for advanced lung cancer

Early palliative care with standard careStandard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Had received systemic treatment for advanced lung cancer before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Lucksamon Thamlikitkul, MD, PhD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucksamon Thamlikitkul, MD, PhD

CONTACT

+6624194489lucksamon.tha@mahidol.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2025

First Posted

January 22, 2025

Study Start

April 2, 2024

Primary Completion

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)