NCT05342571|Completed

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

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

Ohio State University Comprehensive Cancer Center ClinicalTrials.gov

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2 other identifiers

OSU-20339NCI-2020-08120

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredApr 2022

StartedJun 2021

CompletionSep 2022

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Jun 2021

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

June 1, 2021

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2021

Completed

5 months until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed

Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

November 29, 2021

Last Update Submit

October 19, 2023

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

Outcome Measures

Primary Outcomes (7)

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.
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%).
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.
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.
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.
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.
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.
Baseline to Week 15

Study Arms (1)

Supportive care (ABC session, surveys, biospecimen collection)

EXPERIMENTAL

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 InterventionProcedure: Biospecimen CollectionOther: Electronic Health Record ReviewOther: Informational InterventionOther: Survey Administration