Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Lung Carcinoma | Lung Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Lung Carcinoma | Lung Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVA Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVB Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral, Psychological or Informational Intervention | Other | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Informational Intervention | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (ABC session, surveys, biospecimen collection)
- description
- 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.
- interventionNames
- Other: Behavioral, Psychological or Informational Intervention
- Procedure: Biospecimen Collection
- Other: Electronic Health Record Review
- Other: Informational Intervention
- Other: Survey Administration
Primary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available