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Completed

NCT Number: NCT05342571

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

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 information

Conditions

Advanced Lung Carcinoma Lung Diseases Lung Neoplasms Metastatic Lung Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral, Psychological or Informational Intervention

Other

Participate in ABC session

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected

Electronic Health Record Review

Other

Medical records reviewed

Informational intervention

Other

Receive patient guidebook

Survey Administration

Other

Complete surveys

Primary outcomes

  1. Acceptability, measured by Patient Satisfaction Survey (PSS)

    Time frame: Up to 2 months post-treatment

    Descriptive statistics of Patient Satisfaction Survey scores will examine if patient satisfaction scores for a biobehavioral/cognitive (ABC) treatment are "mostly satisfied." The PSS is a 15-item measure which asks patients to rate each ABC intervention component on a 4-point Likert scale ranging from 1 ("not helpful at all") to 4 ("very helpful). Items are summed and averaged. An average score of 3 or higher is considered to represent treatment satisfaction.

  2. Retention

    Time frame: Baseline up to 2 months post-treatment

    Descriptive statistics of patient enrollment and retention rate for ABC will also be used. Patient enrollment will be measured by counting the number of patients who sign consent and enroll onto the trial. Retention will be measured by calculating the number of patients who complete 7 of 14 sessions (50%).

  3. Change of depressive symptoms using Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline up to 2 months post-treatment

    Dependent-samples t-tests will examine feasibility by testing change of depressive symptoms via the PHQ-9 from pre- to post-treatment. The PHQ-9 scores can range from 0 to 27, with higher scores indicating more severe depression.

  4. Change of anxiety symptoms using Generalized Anxiety Disorder Scale (GAD-7)

    Time frame: Baseline up to 2 months post-treatment

    Dependent-samples t-tests will examine feasibility by testing change of anxiety symptoms via the GAD-7 from pre- to post-treatment. The GAD-7 scores can range from 0 to 21, with higher scores indicating more severe anxiety.

  5. Biospecimen analysis: Neutrophil/lymphocyte ratio (NLR)

    Time frame: Baseline to Week 15

    Neutrophil/lymphocyte ratio (NLR) will be calculated by collecting neutrophil count and lymphocyte count from laboratory tests, and dividing neutrophil by lymphocyte count to receive the ratio. This will be conducted at 4 time points: baseline, week 5, week 10, and week 15. Changes in NLR over time will be evaluated using longitudinal mixed models within a joint modeling framework.

  6. Biospecimen analysis: Platelet/lymphocyte ratio (PLR)

    Time frame: Baseline to Week 15

    Platelet/lymphocyte ratio (PLR) will be calculated by collecting platelet count and lymphocyte count from laboratory tests, and dividing platelets by lymphocyte count to receive the ratio. This will be conducted at 4 time points: baseline, week 5, week 10, and week 15. Changes in PLR over time will be evaluated using longitudinal mixed models within a joint modeling framework.

  7. Biospecimen analysis: Inflammation (Interleukin-6)

    Time frame: Baseline to Week 15

    Inflammation will be calculated by conducting the Interleukin-6 (IL-6) immunoassay on patient blood samples. This will be conducted at 4 time points: baseline, week 5, week 10, and week 15. Changes in NLR over time will be evaluated using longitudinal mixed models within a joint modeling framework.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Stress and Immunity in Lung Cancer Patients: Pilot Test of a Biobehavioral/Cognitive (ABC) Treatment for Stress, Depression, and Anxiety

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2022
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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