Cognitive-Behavioral Stress Management Device for the Treatment of Anxiety and Depressive Symptoms in Patients With Stage I-III Breast or Lung Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage IA Breast Cancer AJCC v8
- Anatomic Stage IB Breast Cancer AJCC v8
- Prognostic Stage III Breast Cancer AJCC v8
- Stage I Lung Cancer AJCC v8
- Stage IIB Lung Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage IIA Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Stage IB Lung Cancer AJCC v8
- Stage IIA Lung Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
- Prognostic Stage IIA Breast Cancer AJCC v8
- Prognostic Stage I Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Anatomic Stage IIB Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- Stage III Lung Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IA Breast Cancer AJCC v8
- Stage IA1 Lung Cancer AJCC v8
- Prognostic Stage IB Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Stage IIIB Lung Cancer AJCC v8
- Stage IA2 Lung Cancer AJCC v8
- Stage IIIC Lung Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Lung Non-Small Cell Carcinoma
- Stage IA3 Lung Cancer AJCC v8
- Stage II Lung Cancer AJCC v8
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 cell lung cancer currently undergoing treatment or recently completed treatment (< 3 months). SECONDAR...
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 cell lung cancer currently undergoing treatment or recently completed treatment (< 3 months). SECONDARY OBJECTIVES: I. To collect preliminary data regarding the efficacy of the intervention with regard to improvements in patients' reported symptoms of distress. II. To evaluate patient safety and risks associated with screening procedures (severe anxiety or depression) as well as during receipt of the digital intervention. OUTLINE: Prior to participating in the study patients complete an online baseline questionnaire to assess anxiety and depression and general quality of life, as well as some specific questions related to their coping. They are also interviewed by a clinician who rates their level of anxiety and depression. After this, patients use the BNT001 app and undergo 10 sessions of CBSM over 45-60 minutes each consisting of cancer-specific educational videos, guided relaxation training, interactive exercises, and discussion modules. Following completion of the 5th session, patients undergo a telephone check-in assessment to see how things are going, update their treatments and medications, and schedule a phone call to assess for adverse events. At the end of the 10th session, patients complete a post-treatment online questionnaire and a phone debriefing interview to discuss their experience with the intervention.
Tracking Information
- NCT #
- NCT04705025
- Collaborators
- Blue Note Therapeutics
- Investigators
- Principal Investigator: Patricia A Ganz UCLA / Jonsson Comprehensive Cancer Center
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