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Behavioral, Psychological or Informational Intervention for Stage IV Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stage IV Lung Cancer+4 MoreBehavioral, Psychological or Informational Intervention - Other
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is studying a treatment for stress, depression, and anxiety in patients with stage IV lung cancer. The treatment is a combination of biobehavioral intervention and cognitive therapy.

Eligible Conditions
  • Lung Cancer
  • Stage IV Lung Cancer
  • Stage IVA Lung Cancer
  • Stage IVB Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

7 Primary · 0 Secondary · Reporting Duration: Up to 2 months post-treatment

Baseline to Week 15
Biospecimen analysis: Inflammation (Interleukin-6)
Biospecimen analysis: Neutrophil/lymphocyte ratio (NLR)
Biospecimen analysis: Platelet/lymphocyte ratio (PLR)
Month 2
Change of anxiety symptoms using Generalized Anxiety Disorder Scale (GAD-7)
Change of depressive symptoms using Patient Health Questionnaire-9 (PHQ-9)
Retention
Month 2
Acceptability, measured by Patient Satisfaction Survey (PSS)

Trial Safety

Safety Progress

1 of 3

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1
Elimusertib
1
Antineoplastic Immune Cell
1
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Trial Design

1 Treatment Group

Supportive care (ABC session, surveys, biospecimen collection)
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Behavioral, Psychological or Informational Intervention · No Placebo Group · N/A

Supportive care (ABC session, surveys, biospecimen collection)Experimental Group · 5 Interventions: Electronic Health Record Review, Survey Administration, Behavioral, Psychological or Informational Intervention, Informational Intervention, Biospecimen Collection · Intervention Types: Other, Other, Other, Other, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 1
~670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 months post-treatment

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
287 Previous Clinical Trials
285,973 Total Patients Enrolled
Barbara Andersen, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
3 Previous Clinical Trials
110 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of advanced (stage IV) lung cancer with staging confirmed by pathology report.
Moderate to severe symptoms of depression (>= 8 on PHQ-9) and/or moderate to severe symptoms of anxiety (>= 10 on GAD-7).
You are willing to provide access to medical records, provide biospecimens, and respond to PRO assessments.
References

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