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

• ClinicalTrials.gov Identifier: NCT04862195
• Recruitment Status: Terminated
• First Posted: April 27, 2021
• Last Update Posted: September 13, 2022
• Sponsor: Blue Note Therapeutics
• Information provided by (Responsible Party): Blue Note Therapeutics

Study Description

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.

Condition or disease	Intervention/treatment	Phase
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	Device: Attune™; Device: Cerena™	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: 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
• Actual Study Start Date: May 15, 2021
• Actual Primary Completion Date: September 1, 2022
• Actual Study Completion Date: September 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Cancer-related symptoms of anxiety (1) [ Time Frame: Baseline up to Week 10 ]
   Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety

Secondary Outcome Measures :

1. Cancer-related symptoms of depression (1) [ Time Frame: Baseline up to Week 10 ]
   Percent reduction in PROMIS-D scores, reduction indicates reduced depression
2. Cancer-related symptoms of anxiety (2) [ Time Frame: Baseline up to Week 12 ]
   Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety
3. 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
4. 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
5. 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

Other Outcome Measures:

1. 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.
2. 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.
3. 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.
4. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

OPN Healthcare

Glendale, California, United States, 91203

Oncology Physicians Network Healthcare

Los Alamitos, California, United States, 90720

Redlands Oncology

Redlands, California, United States, 92373

United States, Connecticut

Eastern CT Hematology and Oncology Associates

Norwich, Connecticut, United States, 06360

United States, Illinois

Illinios Cancer Care

Peoria, Illinois, United States, 61615-7828

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

United States, Michigan

Rogel Cancer Center | University of Michigan

Ann Arbor, Michigan, United States, 48109-0944

United States, Montana

SCL Health

Billings, Montana, United States, 59102

United States, New Jersey

New Jersey Center for Cancer Research

Brick, New Jersey, United States, 08724

United States, New York

New York Cancer & Blood Specialists

Port Jefferson Station, New York, United States, 11776

United States, Ohio

Tri-County Hematology and Oncology-Massillon

Massillon, Ohio, United States, 44646

United States, Texas

MD Anderson

Houston, Texas, United States, 77030

United States, Washington

Northwest Medical Specialty

Tacoma, Washington, United States, 98405

Sponsors and Collaborators

Blue Note Therapeutics

Investigators

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

More Information

• Responsible Party: Blue Note Therapeutics
• ClinicalTrials.gov Identifier: NCT04862195
• Other Study ID Numbers: PROT001
• First Posted: April 27, 2021
• Last Update Posted: September 13, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Breast Neoplasms; Lung Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases