Status:
TERMINATED
Cognitive-Behavioral Stress Management Device for the Treatment of Anxiety and Depressive Symptoms in Patients With Stage I-III Breast or Lung Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
Blue Note Therapeutics
Conditions:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 can...
Detailed Description
PRIMARY OBJECTIVE: I. To assess the feasibility of implementing and evaluating a digital cognitive-behavioral stress management (CBSM) device, BNT001, in stage I-III breast or stage I-III non-small c...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04705025
Start Date
April 8 2021
End Date
March 30 2023
Last Update
July 25 2023
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095