Cognitive-Behavioral Stress Management Device for the Treatment of Anxiety and Depressive Symptoms in Patients With Stage I-III Breast or Lung Cancer
This phase II trial studies the effect of a digital application (app), BNT001, on cognitive-behavioral stress management in patients with stage I-III breast or lung cancer. The app is designed for cancer patients to treat anxiety and depressive symptoms related to their cancer diagnosis. The purpose of this study is to develop and refine procedures for eligibility screening, suicide risk assessment, and delivery of the app prior to the launch of a phase III randomized trial. The impact of the app in managing stress and improving quality of life and mood is a secondary aim.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jul 25, 2023 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Supportive Care
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Jonsson Comprehensive Cancer Center
- Interventions being studied
- Behavioral: Cognitive Behavior Therapy; Other: Interview; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Age 18 years or older
- Diagnosis of stage I-III breast cancer or stage I-III non-small cell lung cancer
- Currently in active treatment or have completed initial cancer directed treatments (surgery, radiation, chemotherapy) within the past 3 months
- Patients showing moderate anxiety (General Anxiety Disorder-7 Questionnaire \[GAD-7\] \> 10) or mild depression (Patient Health Questionnaire depression scale \[PHQ-8\] score 5-11)
- Fluent in English
- Has access to smartphone or tablet capable of running iOS or Android software
- Previous history of cancer
- \< 2-year (yr) survival prognosis
- Endorses thoughts of self-harm on question 9 of the Patient Health Questionnaire-9 (PHQ-9) (any score \> 0)
- Currently participating in investigative behavioral intervention trial for treatment of anxiety or depression
- Participant is unable to complete training, cognitive deficits, major psychiatric conditions, psycho-social conditions; lack of access to internet accessible device; other social conditions that would interfere with adherence to self-directed care, such that in investigator's opinion the participant would be unable to complete the study
- Recently completed use of Blue Note Therapeutics COVID Cancer Care Program or other Blue Note Therapeutics-sponsored study
- Planning to seek other psychosocial support services while participating in this study
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 25, 2023. Always confirm current availability with the study team.