Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices as Adjunctive Oncology Treatment

• ClinicalTrials.gov Identifier: NCT04862195
• Recruitment Status: Active, not recruiting
• First Posted: April 27, 2021
• Last Update Posted: April 22, 2022
• Sponsor: Blue Note Therapeutics
• Information provided by (Responsible Party): Blue Note Therapeutics

Tracking Information

• First Submitted Date: April 19, 2021
• First Posted Date: April 27, 2021
• Last Update Posted Date: April 22, 2022
• Actual Study Start Date: May 15, 2021
• Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 26, 2021)

Cancer-related symptoms of anxiety (1) [ Time Frame: Baseline up to Week 10 ]

Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 26, 2021)

• Cancer-related symptoms of depression (1) [ Time Frame: Baseline up to Week 10 ]
  Percent reduction in PROMIS-D scores, reduction indicates reduced depression
• Cancer-related symptoms of anxiety (2) [ Time Frame: Baseline up to Week 12 ]
  Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety
• Cancer-related symptoms of anxiety (3) [ Time Frame: Baseline up to Week 10 ]
  Percent reduction in Clinical Global Impression Scale and Improvement scores, reduction indicates reduced anxiety
• Cancer-related symptoms of depression (4) [ Time Frame: Baseline up to Week 12 ]
  Percent reduction in Clinical Global Impression Scale and Improvement scores, reduction indicates reduced depression
• Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients [ Time Frame: Baseline up to Week 10 ]
  Higher scores indicate higher ease of use / easier to use applications

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: April 26, 2021)

• Quality of life via PROMIS-Global Health v1.2 [ Time Frame: Weeks 10 and Week 12 ]
  The PROMIS Global Health measures assess an individual's physical, mental, and social health. The measures are generic, rather than disease-specific, and often use an "In General" item context as it is intended to globally reflect individuals' assessment of their health. The adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health (Promis-Global Health Scoring Manual, 2017). Higher scores for responses always indicate better health.
• Patient self-efficacy via the Patient Activation Measure-13 (PAM-13) [ Time Frame: Weeks 10 ]
  Patient Activation Measures-the knowledge, skills, and confidence to manage one's health is associated with improved self-management behaviors in cancer patients. A patient activation measure (PAM) using PAM-13 will be used to assess participant engagement at baseline after PROMIS-A and PROMIS-D are completed and at Week 10. Higher scores indicate higher self-efficacy.
• Patient self-efficacy via the Measurement of Current Status (MOCS) Part A and Part B [ Time Frame: Baseline, Week 6, and Week 10 ]
  The Measure of Current Status (MOCS) scale comes from research on the effects of a multi-modal cognitive-behavioral stress management intervention on the psychosocial well-being of cancer patients. The MOCS has two sections. Part A is items measuring participants' current self-perceived status on several skills that are targeted by the intervention: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Part B assesses potential "nonspecific effects" of the intervention: feelings of normalcy vs. alienation, sense of cohesiveness with other patients, perceptions of care from persons around them, and a sense of being better off than other cancer patients. All items were framed in such a way that they are sensible to participants in both conditions. MOCS measurements will be taken at Baseline, Week 6, and Week 10. Higher scores indicate higher self-efficacy.
• Immune cell transcription [ Time Frame: Baseline up to Week 12 ]
  Analyses will focus on inflammatory gene expression and related gene regulation pathways due to their established relevance for disease progression/recurrence in the aftermath of cancer diagnosis and treatment, and their role in promoting symptoms of depression or anxiety via effects on central nervous system function

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices as Adjunctive Oncology Treatment
• Official Title: Double-blinded, Randomized, Adaptive Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices (Attune™ and Cerena™) as Interventions for Physical and Emotional Health in Adjunctive Oncology Treatment

Brief Summary

This is a non-significant risk, double-blinded, randomized, registrational study to compare the effectiveness of two digital, software only, medical devices (SaMD) (attune™ and cerena™) in reducing cancer-related anxiety and depression symptoms when used adjunctively with multidisciplinary (medical, psychosocial) oncology usual care regimens for up to 10 weeks.

Study population will consist of up to 553 participants with stage I-III breast cancer or stage I-III NSCLC. The primary endpoint is percent improvement in anxiety symptoms at Week 10 and secondary endpoints of percent improvement in depressive symptoms will be assessed at Week 12.

An interim analysis for efficacy and futility will be conducted once 236 participants have completed the study.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Stage I Lung Cancer AJCC v8
• Stage II Lung Cancer AJCC v8
• Stage III Lung Cancer AJCC v8

Intervention

• Device: Attune™
  Software as a medical device
• Device: Cerena™
  Software as a medical device

Study Arms

• Active Comparator: Attune™
  Attune™ is a completely digital, 10-session, cognitive behavioral therapeutic intervention.
  Intervention: Device: Attune™
• Active Comparator: Cerena™
  Cerena™ is a completely digital, 10-session, health education and wellness intervention.
  Intervention: Device: Cerena™

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 20, 2022): 30
• Original Estimated Enrollment (submitted: April 26, 2021): 553
• Estimated Study Completion Date: August 2022
• Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Stage I-III breast cancer or Stage I-III NSCLC who are currently in active treatment or have completed initial cancer directed treatments (surgery, radiation, chemotherapy) within the past 3 months;
• Are experiencing at least moderate anxiety (GAD-7 >10) or mild-to-moderate depression (PHQ-8 score 5-11);
• Are fluent in English; and
• Have access to smartphone, or tablet capable of running iOS or Android software.

Exclusion Criteria:

• Previous history of cancer;
• <2-yr survival prognosis as determined by treating clinician;
• Currently participating in investigative CBT trial for treatment of anxiety or depression;
• Participant is unable to complete training, has cognitive deficits, more severe psychiatric conditions, lack of access to internet accessible device or psycho-social conditions (e.g., 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; and
• PHQ-9 Q9 response >0 AND Columbia Suicide Severity Risk Scale (or equivalent) score of Category 2- "suicidal ideation" at screening.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04862195
• Other Study ID Numbers: PROT001
• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Blue Note Therapeutics
• Study Sponsor: Blue Note Therapeutics
• Collaborators: Not Provided

Investigators

• Principal Investigator: Patricia A Ganz, MD; University of California, Los Angeles

• PRS Account: Blue Note Therapeutics
• Verification Date: April 2022