Cognitive-Behavioral Stress Management Device for the Treatment of Anxiety and Depressive Symptoms in Patients With Stage I-III Breast or Lung Cancer (BNT001)

Phase II Pilot Study Evaluating the Feasibility of Delivery and Evaluation of a Digital Cognitive-Behavioral Stress Management (CBSM) Device (BNT001) for Treatment of Anxiety and Depressive Symptoms in Patients With Stage I-III Breast or Stage I-III Non-Small Cell 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.

Study Overview

• Status: Terminated
• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage IIA Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage I Lung Cancer AJCC v8; Stage IA1 Lung Cancer AJCC v8; Stage IA2 Lung Cancer AJCC v8; Stage IA3 Lung Cancer AJCC v8; Stage IB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Interview; Behavioral: Cognitive Behavior Therapy

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 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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA / Jonsson Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive care (BNT001 app, CBSM, interview); 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.

Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Interview; Complete interview; Behavioral: Cognitive Behavior Therapy; Undergo CBSM using the BNT001 app; Other Names: CT; CBT; cognitive therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of implementing and evaluating the BNT001 digital Cognitive-Behavioral Stress Management device	Feasibility will be evaluated by the rate of recruitment, total number of screens and number of screen fails, treatment adherence (as measured on the backend based on time and regularity of engaging with the digital platform), and number of study completers versus enrolled. The analytic strategy will be primarily descriptive and qualitative. Will also obtain qualitative feedback on participation in the study and study intervention through the end of study de-briefing interview.	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in global health	Change in Patient Reported Outcomes Measurement and Information System (PROMIS)-Global Health Scale v.1.2 using one sample t-tests.	Baseline up to 10 weeks
Change in anxiety symptoms	Will be assessed by PROMIS-Anxiety version 1.0 using one sample t-tests.	Baseline up to 10 weeks
Change in depression symptoms	Will be assessed by PROMIS-Depression version 1.0 using one sample t-tests.	Baseline up to 10 weeks
Change in anxiety	Will be assessed by the Hamilton Rating Scale for Anxiety.	Baseline up to 10 weeks
Change in depression	Will be assessed by the Hamilton Depression Rating Scale.	Baseline up to 10 weeks
Patient safety and risks	Will concatenate data regarding the number of individuals requiring severe psychopathology management identified during screening procedures, as well as the number of individuals requiring clinical assessment for severe symptoms during the course of the study.	Up to 10 weeks

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: Blue Note Therapeutics
• Investigators: Principal Investigator: Patricia A Ganz, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2021
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; depression; cognitive behavioral therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Skin Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Breast Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Depression; Breast Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 20-002000; NCI-2020-11560 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes