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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
OPN Healthcare
Glendale, California, United States
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
Massachusetts General Hospital
Boston, Massachusetts, United States
Rogel Cancer Center | University of Michigan
Ann Arbor, Michigan, United States
SCL Health
Billings, Montana, United States
New Jersey Center for Cancer Research
Brick, New Jersey, United States
New York Cancer & Blood Specialists
Port Jefferson Station, New York, United States
...and 3 more locations
Cancer-related symptoms of anxiety (1)
Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety
Time frame: Baseline up to Week 10
Cancer-related symptoms of depression (1)
Percent reduction in PROMIS-D scores, reduction indicates reduced depression
Time frame: Baseline up to Week 10
Cancer-related symptoms of anxiety (2)
Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline up to Week 10
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