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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-11560 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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manufacturer reevaluating Digital cognitive-behavioral stress management (CBSM) device (Attunetm)
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| Name | Class |
|---|---|
| Blue Note Therapeutics | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavior Therapy | Behavioral | Undergo CBSM using the BNT001 app |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia A Ganz | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
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| Interview | Other | Complete interview |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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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 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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