Anatomic Stage I Breast Cancer AJCC v8BNT001NCT04705025
Cognitive-Behavioral Stress Management Device for the Treatment of Anxiety and Depressive Symptoms in Patients With Stage I-III Breast or Lung Cancer
A study testing Cognitive Behavior Therapy, Interview and Quality-of-Life Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- What is being tested?
- Cognitive Behavior Therapy, Interview and Quality-of-Life Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2021to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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
- Being tested
- Cognitive Behavior Therapy, Interview, Quality-of-Life Assessment, Questionnaire Administration
- Keywords
- Anxiety, depression, cognitive behavioral therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior TherapyBehavioural
Also called CBT, cognitive therapy, CT
Undergo CBSM using the BNT001 app
InterviewOther
Complete interview
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Behavior Therapy; Other: Interview; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (6)
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.
Measured: Baseline up to 10 weeks
Change in anxiety symptoms
Will be assessed by PROMIS-Anxiety version 1.0 using one sample t-tests.
Measured: Baseline up to 10 weeks
Change in depression symptoms
Will be assessed by PROMIS-Depression version 1.0 using one sample t-tests.
Measured: Baseline up to 10 weeks
Change in anxiety
Will be assessed by the Hamilton Rating Scale for Anxiety.
Measured: Baseline up to 10 weeks
Change in depression
Will be assessed by the Hamilton Depression Rating Scale.
Measured: 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.
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start8 Apr 2021
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Why it stopped: manufacturer reevaluating Digital cognitive-behavioral stress management (CBSM) device (Attunetm)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Note Therapeutics
- Responsible party
- Sponsor
- Investigators
- Patricia A Ganz, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705025
- Sponsor's protocol ID
- 20-002000
- Other IDs
- NCI-2020-11560
- Acronym
- BNT001
- Status last verified
- Jul 2023
- First submitted
- 8 Jan 2021
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04705025
- Acronym / sponsor ID
- BNT001 / 20-002000
- 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
- Keywords
- Anxiety, depression, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: manufacturer reevaluating Digital cognitive-behavioral stress management (CBSM) device (Attunetm)
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Blue Note Therapeutics
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (BNT001 app, CBSM, interview) | Experimental | Behavioral: Cognitive Behavior Therapy, Other: Interview, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPrior 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavior TherapyAlso: CBT, cognitive therapy, CTUndergo CBSM using the BNT001 app | Behavioural | Supportive care (BNT001 app, CBSM, interview) |
| InterviewComplete interview | Other | Supportive care (BNT001 app, CBSM, interview) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (BNT001 app, CBSM, interview) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (BNT001 app, CBSM, interview) |
Primary outcome
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.
6 secondary outcomes
Change in global health
Time frame: Baseline up to 10 weeks
Change in anxiety symptoms
Time frame: Baseline up to 10 weeks
Change in depression symptoms
Time frame: Baseline up to 10 weeks
Change in anxiety
Time frame: Baseline up to 10 weeks
Change in depression
Time frame: Baseline up to 10 weeks
Patient safety and risks
Time frame: Up to 10 weeks
Results and safety
The study was stopped early (reason given: manufacturer reevaluating Digital cognitive-behavioral stress management (CBSM) device (Attunetm)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia A Ganz principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy, Interview and Quality-of-Life Assessment in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: manufacturer reevaluating Digital cognitive-behavioral stress management (CBSM) device (Attunetm)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing and evaluating the BNT001 digital Cognitive-Behavioral Stress Management device (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.