Status:
TERMINATED
Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices as Adjunctive Oncology Treatment
Lead Sponsor:
Blue Note Therapeutics
Conditions:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ca...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04862195
Start Date
May 15 2021
End Date
September 1 2022
Last Update
September 13 2022
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
OPN Healthcare
Glendale, California, United States, 91203
2
Oncology Physicians Network Healthcare
Los Alamitos, California, United States, 90720
3
Redlands Oncology
Redlands, California, United States, 92373
4
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360