Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices as Adjunctive Oncology Treatment
NCT ID: NCT04862195
Last Updated: 2022-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
31 participants
INTERVENTIONAL
2021-05-15
2022-09-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Attune™
Attune™ is a completely digital, 10-session, cognitive behavioral therapeutic intervention.
Attune™
Software as a medical device
Cerena™
Cerena™ is a completely digital, 10-session, health education and wellness intervention.
Cerena™
Software as a medical device
Interventions
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Attune™
Software as a medical device
Cerena™
Software as a medical device
Eligibility Criteria
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Inclusion Criteria
* 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
* \<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.
18 Years
75 Years
ALL
No
Sponsors
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Blue Note Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Patricia A Ganz, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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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
Tri-County Hematology and Oncology-Massillon
Massillon, Ohio, United States
MD Anderson
Houston, Texas, United States
Northwest Medical Specialty
Tacoma, Washington, United States
Countries
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Other Identifiers
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PROT001
Identifier Type: -
Identifier Source: org_study_id
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