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

NCT04705025 | Terminated DMC

• 2 other identifiers: 20-002000NCI-2020-11560
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

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; 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

Keywords

Anxiety; depression; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in global health

  Baseline up to 10 weeks

• Change in anxiety symptoms

  Baseline up to 10 weeks

• Change in depression symptoms

  Baseline up to 10 weeks

• Change in anxiety

  Baseline up to 10 weeks

• Change in depression

  Baseline up to 10 weeks

Study Arms (1)

Supportive care (BNT001 app, CBSM, interview)

EXPERIMENTAL

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.

Behavioral: Cognitive Behavior Therapy; Other: Interview; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Cognitive Behavior Therapy BEHAVIORAL

Undergo CBSM using the BNT001 app

Also known as: CBT, cognitive therapy, CT

Supportive care (BNT001 app, CBSM, interview)

Interview OTHER

Complete interview

Supportive care (BNT001 app, CBSM, interview)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (BNT001 app, CBSM, interview)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (BNT001 app, CBSM, interview)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Blue Note Therapeutics: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Anxiety Disorders; Depression

Interventions

Cognitive Behavioral Therapy; Interviews as Topic

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Patricia A Ganz

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 12, 2021
• Study Start: April 8, 2021
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

US (1)