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

NCT ID: NCT06786468

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-02

Study Completion Date

2027-04-30

Brief Summary

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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

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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.

Conditions

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Lung Cancer - Non Small Cell Lung Cancer (NSCLC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Early palliative care integration

Intervention Type 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

Intervention Type DRUG

Standard systemic treatment for advanced lung cancer

Standard care

The patients will attend oncology clinic as usual

Group Type ACTIVE_COMPARATOR

Standard systemic treatment for advanced lung cancer

Intervention Type DRUG

Standard systemic treatment for advanced lung cancer

Interventions

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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

Intervention Type OTHER

Standard systemic treatment for advanced lung cancer

Standard systemic treatment for advanced lung cancer

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lucksamon Thamlikitkul, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Siriraj Hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Lucksamon Thamlikitkul, MD, PhD

Role: CONTACT

+6624194489

Facility Contacts

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Lucksamon Thamlikitkul, MD, PhD

Role: primary

+6624194489

Other Identifiers

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068/2567(IRB3)

Identifier Type: -

Identifier Source: org_study_id

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