Impact of Psychological Stress on Treatment Response and Prognosis in Lung Cancer Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Guangzhou Medical University

About this trial

This study explores how psychological stress may influence the treatment response and long-term outcomes in patients with lung cancer. While advances in surgery, chemotherapy, immunotherapy, and targeted therapies have improved survival, emotional well-being remains an often-overlooked factor. We aim to investigate whether high levels of stress, anxiety, or depression at the time of diagnosis or during treatment are linked to poorer responses to therapy or shorter survival. By identifying these associations, the study hopes to highlight the importance of psychological care as part of comprehensive cancer treatment. The findings may inform future strategies to integrate mental health support into routine care for patients with both early-stage and advanced lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

The participants including the patients diagnosed with advanced non-small-cell lung cancer (NSCLC) who received the first-line therapy or neoadjuvant therapy of ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early small-cell lung cancer (SCLC) receiving surgery.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Exposure: psychological stress status

    Other intervention

    The assessment of depressive and anxiety symptoms was conducted using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment 7 (GAD-7). Patients with a PHQ-9 score ≥ 5 or a GAD-7 score ≥ 5 were categorized as the stressed group.

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: Advanced Stage Cohort1 intervention
Group B: Early-Stage Surgical Cohort1 intervention
Group C: neoadjuvant therapy Cohort1 intervention

Trial outcomes

Primary outcomes

1

Advanced Stage Cohort: Progression-free survival (PFS)

Time from the beginning of first-line immunotherapy to the first progression (PD) in patients with lung cancer

Time frame
3 years
2

Early-Stage Surgical Cohort: Disease-free survival (DFS)

The duration between the date after surgery to the date of any recurrence or death firstly

Time frame
5 years
3

neoadjuvant therapy Cohort: Pathologic complete response (pCR) rate

pCR is no viable tumor cells in tumor bed and lymph nodes. The pCR rate is the proportion of patients with a pathologic complete response.

Time frame
3 years

Secondary outcomes

1

Overall survival (OS)

Overall survival (OS) is defined as the duration from the beginning of first-line immunotherapy until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.

Time frame
5 years
2

Objective Response Rate (ORR)

The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Time frame
3 years

Other outcomes

1

The correlation between gut microbiota and chronic stress

The baseline faeces is collected and assessed by 16S rRNA sequencing. And explore the association between gut microbiota and chronic stress during the enrolled observation process

Time frame
5 years
2

The correlation between peripheral stress biomarker and immune cells signature and chronic stress

The baseline peripheral venous blood is collected. The stress biomarkers including epinephrine, cytokines, norepinephrine, cortisol and ACTH. The peripheral immune cells signature and assessed by flow cytometry, including T lymphocytes, B lymphocytes, NK lymphocytes, macrophagocyte, and DC cells.

Time frame
5 years
3

The correlation between tumor microenvironment signature and chronic stress

The baseline paraffin-embedded tissue is collected and assessed by multiplex immunohistochemistry, including T lymphocytes, B lymphocytes, NK lymphocytes, macrophagocyte, and DC cells. And explore the association between tumor microenvironment signature and chronic stress during the enrolled observation process.

Time frame
5 years

Locations

This trial has no locations.

Sponsors and contacts

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