Columbus, Ohio 43210

  • Stage IVB Lung Cancer AJCC v8

Purpose:

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.


Study summary:

PRIMARY OBJECTIVES: I. Conduct a phase IIb pilot of a biobehavioral/cognitive (ABC) therapy intervention for patients with advanced (stage IV) lung cancer (N=40) with moderate to severe depressive symptoms and determine feasibility and treatment adherence. II. Mode of delivery (in person, virtual), frequency of contact, and duration of contacts are studied to identify efficiencies to achieve clinical change. SECONDARY OBJECTIVES: I. Pre/post treatment change on patient reported outcomes (PROs) for depressive symptoms, anxiety symptoms, cancer specific stress, and physical symptoms. II. Compare patients' ABC outcomes to responses of a matched sample (n=40) of patients previously accrued to BLCIO (Beating Lung Cancer in Ohio; ClinicalTrials.gov Identifier: NCT03199651) completing the same measures at equivalent time points using archival, deidentified data. TERTIARY OBJECTIVES: I. To evaluate effects of ABC on prognostic cell numbers/ratios (i.e., neutrophil/lymphocyte ratio, platelet/lymphocyte ratio, and advanced lung cancer inflammation indices) from patients pre to post ABC and comparable time points for the matched BLCIO sample using electronic medical record (eMR) data. II. To evaluate effects of ABC on immunity, conducting correlative studies of inflammation, immune suppressive cells, and downstream effects on T- and natural killer (NK) cell function, using serum samples from ABC patients drawn at accrual, prior to cancer treatment, and 1 and 2 months during treatment. OUTLINE: INTENSIVE I PHASE: Patients participate in ABC sessions consisting of weekly, hour-long sessions for 10 weeks. INTENSIVE II PHASE: Patients not achieving full remission after the first 10 weeks receive 4 additional weekly sessions. MAINTENANCE PHASE (Optional): Patients may participate in 1 ABC session monthly for 4 months. These maintenance sessions serve as "booster" sessions. Patients' medical records are reviewed, and will receive a patient guidebook to provide session-by-session descriptions to assist the patient to focus on the content and homework assignment completion. Patients also complete surveys at pre-treatment, every 2 months during cancer treatment, at post-treatment, and at 1 and 2 months follow-up. Patients also undergo blood collection at the time of initial diagnostic work-up, and at protocol weeks 5, 10, and 15.


Criteria:

Inclusion 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 Exclusion 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


NCT ID:

NCT05342571


Primary Contact:

Principal Investigator
Barbara Andersen, PhD
Ohio State University Comprehensive Cancer Center

The Ohio State University Comprehensive Cancer Center
Phone: 800-293-5066
Email: OSUCCCClinicaltrials@osumc.edu


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43210
United States

Barbara Andersen, PhD
Phone: 614-292-4236
Email: andersen.1@osu.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 28, 2022

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