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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04705025
Recruitment Status : Active, not recruiting
First Posted : January 12, 2021
Last Update Posted : July 7, 2022
Sponsor:
Collaborator:
Blue Note Therapeutics
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE January 8, 2021
First Posted Date  ICMJE January 12, 2021
Last Update Posted Date July 7, 2022
Actual Study Start Date  ICMJE April 8, 2021
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2021)		 Feasibility of implementing and evaluating the BNT001 digital Cognitive-Behavioral Stress Management device [ Time Frame: Up to 1 year ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 8, 2021)		 Feasibility of implementing and evaluating the Attune digital Cognitive-Behavioral Stress Management device [ Time Frame: Up to 1 year ]
Feasibility will be evaluated by the rate of recruitment, total number of screens and number of screen fails, treatment adherence (as measured on the back 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2021)
  • Change in global health [ Time Frame: Baseline up to 10 weeks ]
    Change in Patient Reported Outcomes Measurement and Information System (PROMIS)-Global Health Scale v.1.2 using one sample t-tests.
  • Change in anxiety symptoms [ Time Frame: Baseline up to 10 weeks ]
    Will be assessed by PROMIS-Anxiety version 1.0 using one sample t-tests.
  • Change in depression symptoms [ Time Frame: Baseline up to 10 weeks ]
    Will be assessed by PROMIS-Depression version 1.0 using one sample t-tests.
  • Change in anxiety [ Time Frame: Baseline up to 10 weeks ]
    Will be assessed by the Hamilton Rating Scale for Anxiety.
  • Change in depression [ Time Frame: Baseline up to 10 weeks ]
    Will be assessed by the Hamilton Depression Rating Scale.
  • Patient safety and risks [ Time Frame: Up to 10 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2021)
  • Change in anxiety and depressive symptoms [ Time Frame: Baseline up to 10 weeks ]
    Change in symptoms of anxiety and depressive symptoms, fatigue, sleep, functioning, and quality of life will be assessed by Patient Reported Outcomes Measurement and Information System (PROMIS)-29 using one sample t-tests.
  • Change in anxiety symptoms [ Time Frame: Baseline up to 10 weeks ]
    Will be assessed by PROMIS-Anxiety version 1.0 using one sample t-tests.
  • Change in depression symptoms [ Time Frame: Baseline up to 10 weeks ]
    Will be assessed by PROMIS-Depression version 1.0 using one sample t-tests.
  • Change in anxiety [ Time Frame: Baseline up to 10 weeks ]
    Will be assessed by the Hamilton Rating Scale for Anxiety.
  • Change in depression [ Time Frame: Baseline up to 10 weeks ]
    Will be assessed by the Hamilton Depression Rating Scale.
  • Patient safety and risks [ Time Frame: Up to 10 weeks ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive-Behavioral Stress Management Device for the Treatment of Anxiety and Depressive Symptoms in Patients With Stage I-III Breast or Lung Cancer
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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
  • Lung Non-Small Cell Carcinoma
  • 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
  • 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 II Lung Cancer AJCC v8
  • Stage IIA Lung Cancer AJCC v8
  • Stage IIB Lung Cancer AJCC v8
  • Stage III Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
Intervention  ICMJE
  • Behavioral: Cognitive Behavior Therapy
    Undergo CBSM using the BNT001 app
    Other Names:
    • CBT
    • cognitive therapy
    • CT
  • Other: Interview
    Complete interview
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE 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.
Interventions:
  • Behavioral: Cognitive Behavior Therapy
  • Other: Interview
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 6, 2022)		 4
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2021)		 25
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04705025
Other Study ID Numbers  ICMJE 20-002000
NCI-2020-11560 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jonsson Comprehensive Cancer Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Blue Note Therapeutics
Investigators  ICMJE
Principal Investigator: Patricia A Ganz UCLA / Jonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP