CompletedNot applicableNCT05342571
Official study title

A Biobehavioral/Cognitive Treatment for Stress, Depression, and Anxiety in Patients With Stage IV Lung Cancer

Study summary

This phase IIb trial studies the effect of a biobehavioral/cognitive (ABC) treatment on stress, depression, and anxiety in patients with stage IV lung cancer. Advanced lung cancer and stress or depression are associated with increased inflammation and decreased immunity. ABC is a combination of biobehavioral intervention, which studies the interaction between behavioral and biological processes, and cognitive therapy for the treatment for anxiety and depressive disorders. Giving ABC during lung cancer treatment may reduce stress, depression, and anxiety, and improve patients' quality of life and health.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedBehavioral, Psychological or Informational Intervention and Biospecimen Collection

Plus 3 other study approaches.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 23, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Ohio State University Comprehensive Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Not applicable
Sponsor
Ohio State University Comprehensive Cancer Center
Interventions being studied
Other: Behavioral, Psychological or Informational Intervention; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Informational Intervention; Other: Survey Administration
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Individuals diagnosed with advanced (stage IV) lung cancer with diagnosis and staging confirmed by pathology report
  • Moderate to severe symptoms of depression (\>= 8 on Patients Health Questionaire-9) and/or moderate to severe symptoms of anxiety (\>= 10 on Generalized Anxiety Disorder-7; GAD-7)
  • English-speaking
  • Willingness to provide access to medical records, provide biospecimens, and responses to patient reported outcome (PRO) assessments
  • Ability to understand and willingness to sign an informed consent document
Reasons someone may not be able to joinExclusion criteria
  • Patients to be treated with definitive chemo-radiotherapy
  • Presence of untreated brain metastases
  • Previous lung cancer diagnosis
  • Presence of disabling hearing, vision, or impairing psychiatric conditions (e.g., psychosis, bipolar disorder, substance abuse) preventing consent or completion of self-report measures in English
  • Imminent risk of suicide that precludes outpatient treatment
  • Currently receiving psychological treatment/counseling

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Ohio State University Comprehensive Cancer CenterColumbus, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 23, 2023. Always confirm current availability with the study team.

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