Clinical trial NCT05342571: A Biobehavioral/Cognitive Treatment for Stress, Depression, and Anxiety in Patients With Stage IV Lung Cancer
Official title: Stress and Immunity in Lung Cancer Patients: Pilot Test of a Biobehavioral/Cognitive (ABC) Treatment for Stress, Depression, and Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Lung Carcinoma
Metastatic Lung Carcinoma
Stage IV Lung Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8
Stage IVB Lung Cancer AJCC v8
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Acceptability, measured by Patient Satisfaction Survey (PSS)
timeFrame: Up to 2 months post-treatment
measure: Retention
timeFrame: Baseline up to 2 months post-treatment
measure: Change of depressive symptoms using Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline up to 2 months post-treatment
measure: Change of anxiety symptoms using Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Baseline up to 2 months post-treatment
measure: Biospecimen analysis: Neutrophil/lymphocyte ratio (NLR)
timeFrame: Baseline to Week 15
measure: Biospecimen analysis: Platelet/lymphocyte ratio (PLR)
timeFrame: Baseline to Week 15
measure: Biospecimen analysis: Inflammation (Interleukin-6)
timeFrame: Baseline to Week 15
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Barbara Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
References: