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

January 20, 2025 updated by: Mahidol University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital
        • Contact:
        • Principal Investigator:
          • Lucksamon Thamlikitkul, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early palliative care with standard care
The patients will attend palliative care clinic once a month during the first three months together with oncology clinic visits
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
Active Comparator: Standard care
The patients will attend oncology clinic as usual
Drug: Standard systemic treatment for advanced lung cancer
Standard systemic treatment for advanced lung cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 and 24 weeks after treatment
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.
12 and 24 weeks after treatment
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.
12 and 24 weeks after treatment
One-year survival rate
Time Frame: One year after treatment
One year after treatment
Two-year survival rate
Time Frame: Two years after treatment
Two years after treatment
Proportion of patients who have advanced care plan
Time Frame: six months
six months
Change in utility score measured by EQ-5D-5L questionnaire
Time Frame: 12 and 24 weeks after treatment
12 and 24 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Lucksamon Thamlikitkul, MD, PhD, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 068/2567(IRB3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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