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

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

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.

Study Overview

• Status: Terminated
• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage I Lung Cancer AJCC v8
• Intervention / Treatment: Device: Attune™; Device: Cerena™

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91203
      • OPN Healthcare
    • Los Alamitos, California, United States, 90720
      • Oncology Physicians Network Healthcare
    • Redlands, California, United States, 92373
      • Redlands Oncology
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Eastern CT Hematology and Oncology Associates
  • Illinois
    • Peoria, Illinois, United States, 61615-7828
      • Illinios Cancer Care
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0944
      • Rogel Cancer Center | University of Michigan
  • Montana
    • Billings, Montana, United States, 59102
      • SCL Health
  • New Jersey
    • Brick, New Jersey, United States, 08724
      • New Jersey Center for Cancer Research
  • New York
    • Port Jefferson Station, New York, United States, 11776
      • New York Cancer & Blood Specialists
  • Ohio
    • Massillon, Ohio, United States, 44646
      • Tri-County Hematology and Oncology-Massillon
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson
  • Washington
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Attune™; Attune™ is a completely digital, 10-session, cognitive behavioral therapeutic intervention.	Device: Attune™; Software as a medical device
Active Comparator: Cerena™; Cerena™ is a completely digital, 10-session, health education and wellness intervention.	Device: Cerena™; Software as a medical device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer-related symptoms of anxiety (1)	Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety	Baseline up to Week 10

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life via PROMIS-Global Health v1.2	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.	Weeks 10 and Week 12
Patient self-efficacy via the Patient Activation Measure-13 (PAM-13)	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.	Weeks 10
Patient self-efficacy via the Measurement of Current Status (MOCS) Part A and Part B	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.	Baseline, Week 6, and Week 10
Immune cell transcription	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	Baseline up to Week 12

Collaborators and Investigators

• Sponsor: Blue Note Therapeutics
• Investigators: Principal Investigator: Patricia A Ganz, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Breast Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Breast Neoplasms; Lung Neoplasms
• Other Study ID Numbers: Prot001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No