Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices as Adjunctive Oncology Treatment
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8Stage III Lung Cancer AJCC v8Stage II Lung Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Stage I Lung Cancer AJCC v8
- Interventions
- Device: Attune™Device: Cerena™
- Registration Number
- NCT04862195
- Lead Sponsor
- Blue Note Therapeutics
- 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 available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 31
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Attune™ Attune™ Attune™ is a completely digital, 10-session, cognitive behavioral therapeutic intervention. Cerena™ Cerena™ Cerena™ is a completely digital, 10-session, health education and wellness intervention.
- Primary Outcome Measures
Name Time Method Cancer-related symptoms of anxiety (1) Baseline up to Week 10 Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety
- Secondary Outcome Measures
Name Time Method Cancer-related symptoms of anxiety (2) Baseline up to Week 12 Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety
Cancer-related symptoms of anxiety (3) 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) 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 Baseline up to Week 10 Higher scores indicate higher ease of use / easier to use applications
Cancer-related symptoms of depression (1) Baseline up to Week 10 Percent reduction in PROMIS-D scores, reduction indicates reduced depression
Trial Locations
- Locations (13)
Oncology Physicians Network Healthcare
🇺🇸Los Alamitos, California, United States
Redlands Oncology
🇺🇸Redlands, California, United States
Eastern CT Hematology and Oncology Associates
🇺🇸Norwich, Connecticut, United States
Illinios Cancer Care
🇺🇸Peoria, Illinois, United States
Rogel Cancer Center | University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
MD Anderson
🇺🇸Houston, Texas, United States
Northwest Medical Specialty
🇺🇸Tacoma, Washington, United States
OPN Healthcare
🇺🇸Glendale, California, United States
New York Cancer & Blood Specialists
🇺🇸Port Jefferson Station, New York, United States
SCL Health
🇺🇸Billings, Montana, United States
New Jersey Center for Cancer Research
🇺🇸Brick, New Jersey, United States
Tri-County Hematology and Oncology-Massillon
🇺🇸Massillon, Ohio, United States