Clinical trial NCT04705025: 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: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Blue Note Therapeutics
First posted: 2021-01-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of implementing and evaluating the BNT001 digital Cognitive-Behavioral Stress Management device
timeFrame: Up to 1 year
Secondary outcomes:
measure: Change in global health
timeFrame: Baseline up to 10 weeks
measure: Change in anxiety symptoms
timeFrame: Baseline up to 10 weeks
measure: Change in depression symptoms
timeFrame: Baseline up to 10 weeks
measure: Change in anxiety
timeFrame: Baseline up to 10 weeks
measure: Change in depression
timeFrame: Baseline up to 10 weeks
measure: Patient safety and risks
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Patricia A Ganz
role: PRINCIPAL_INVESTIGATOR
References: