Open Actively Recruiting

Cognitive-Behavioral Stress Management Device for the Treatment of Anxiety and Depressive Symptoms in Patients With Stage I-III Breast or Lung Cancer

About

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 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.

Primary Purpose
Supportive Care
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • 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 Criteria:

  • 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

Join this Trial

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Study Stats
Protocol No.
20-002000
Category
Hematology-Oncology
Oncology
Contact
Barbara Kahn-Mills
Location
  • UCLA Alhambra
  • UCLA Arcadia
  • UCLA Beverly Hills
  • UCLA Burbank
  • UCLA Calabasas
  • UCLA Encino
  • UCLA Fountain Valley
  • UCLA Hollywood
  • UCLA Irvine
  • UCLA Laguna Hills
  • UCLA Lancaster
  • UCLA Parkside
  • UCLA Pasadena
  • UCLA Playa Marina
  • UCLA Porter Ranch
  • UCLA Redondo Beach
  • UCLA San Luis Obispo
  • UCLA Santa Monica
  • UCLA Simi Valley
  • UCLA Torrance
  • UCLA Valencia
  • UCLA Ventura
  • UCLA Westlake Village
  • UCLA Westwood
  • UCLA Woodland Hills
For Providers
NCT No.
NCT04705025
For detailed technical eligibility, visit ClinicalTrials.gov.