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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMahidol University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Had received systemic treatment for advanced lung cancer before

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early palliative care integration

    Other intervention

    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

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Early palliative care with standard careExperimental treatment 2 interventions
Group B: Standard careActive comparator 1 intervention

Trial outcomes

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.

Time frame
12 weeks after treatment

Secondary outcomes

1

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

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.

Time frame
12 and 24 weeks after treatment
2

Change in mental health score (PHQ-9)

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.

Time frame
12 and 24 weeks after treatment
3

Change in pain score

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.

Time frame
12 and 24 weeks after treatment
4

One-year survival rate

Time frame
One year after treatment

Other outcomes

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