An interventional study of Behavioral, Psychological or Informational Intervention and Biospecimen Collection in Advanced Lung Carcinoma, Metastatic Lung Carcinoma and Stage IV Lung Cancer AJCC v8, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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.
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.
7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 375 studies on the registry; 82 are open to participants now.
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Exclusion Criteria:
Phase 1 of the intervention (10 weeks) will follow the following agenda: 1) Overview and progressive muscle relaxation, 2) Seeking and asking for disease-related and treatment-related information, 3) Problem solving skills, 4) Breathing techniques and sleep hygiene, 5) Assertive communication skills, 6) Identifying social network, 7) Asking for support, 8) Further information on social support, 9) Physical activity, and 10) Review of major topics, transition. Phase 2 of the intervention (4 weeks) which will be completed only by patients who do not experience remission in depressive symptoms by the end of phase 1, will follow the following agenda: 1) Identifying negative thoughts and problematic thinking patterns, 2) Generating alternative thoughts, 3) Behavioral activation, and 4) Review and wrap-up, transition to optional maintenance. Each session in Phase 1 and Phase 2 occurs once per week, for 60 minutes each. Maintenance sessions occur monthly, 60 minutes each.
Other: Behavioral, Psychological or Informational Intervention · Procedure: Biospecimen Collection · Other: Electronic Health Record Review · Other: Informational Intervention · Other: Survey Administration
Participate in ABC session
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected
Medical records reviewed
Receive patient guidebook
Complete surveys
Acceptability, measured by Patient Satisfaction Survey (PSS)
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.
Time frame: Up to 2 months post-treatment
Retention
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%).
Time frame: Baseline up to 2 months post-treatment
Change of depressive symptoms using Patient Health Questionnaire-9 (PHQ-9)
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.
Time frame: Baseline up to 2 months post-treatment
Change of anxiety symptoms using Generalized Anxiety Disorder Scale (GAD-7)
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.
Time frame: Baseline up to 2 months post-treatment
Biospecimen analysis: Neutrophil/lymphocyte ratio (NLR)
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.
Time frame: Baseline to Week 15
Biospecimen analysis: Platelet/lymphocyte ratio (PLR)
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.
Time frame: Baseline to Week 15
Biospecimen analysis: Inflammation (Interleukin-6)
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.
Time frame: Baseline to Week 15
Plan to share: No
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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