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

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04862195
• Other study ID #: PROT001
• Status: Terminated
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2022
• Source: Blue Note Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Breast Neoplasms
• Lung Neoplasms
• 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
• Cerena™
Software as a medical device

Locations

Country	Name	City	State
United States	Rogel Cancer Center | University of Michigan	Ann Arbor	Michigan
United States	SCL Health	Billings	Montana
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	New Jersey Center for Cancer Research	Brick	New Jersey
United States	OPN Healthcare	Glendale	California
United States	MD Anderson	Houston	Texas
United States	Oncology Physicians Network Healthcare	Los Alamitos	California
United States	Tri-County Hematology and Oncology-Massillon	Massillon	Ohio
United States	Eastern CT Hematology and Oncology Associates	Norwich	Connecticut
United States	Illinios Cancer Care	Peoria	Illinois
United States	New York Cancer & Blood Specialists	Port Jefferson Station	New York
United States	Redlands Oncology	Redlands	California
United States	Northwest Medical Specialty	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Blue Note Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	Cancer-related symptoms of anxiety (1)	Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety	Baseline up to Week 10
Secondary	Cancer-related symptoms of depression (1)	Percent reduction in PROMIS-D scores, reduction indicates reduced depression	Baseline up to Week 10
Secondary	Cancer-related symptoms of anxiety (2)	Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety	Baseline up to Week 12
Secondary	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
Secondary	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
Secondary	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