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

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

Sponsors

Lead Sponsor: Blue Note Therapeutics

Source 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.

Overall Status Recruiting
Start Date 2021-05-15
Completion Date 2022-08-01
Primary Completion Date 2022-06-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Cancer-related symptoms of anxiety (1) Baseline up to Week 10
Secondary Outcome
Measure Time Frame
Cancer-related symptoms of depression (1) Baseline up to Week 10
Cancer-related symptoms of anxiety (2) Baseline up to Week 12
Cancer-related symptoms of anxiety (3) Baseline up to Week 10
Cancer-related symptoms of depression (4) Baseline up to Week 12
Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients Baseline up to Week 10
Enrollment 553
Condition
Intervention

Intervention Type: Device

Intervention Name: Attune™

Description: Software as a medical device

Arm Group Label: Attune™

Intervention Type: Device

Intervention Name: Cerena™

Description: Software as a medical device

Arm Group Label: Cerena™

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Patricia A Ganz, MD Principal Investigator University of California, Los Angeles
Overall Contact

Last Name: Raju Joshi, PhD

Phone: (424) 332-3551

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator:
Innovative Clinical Research Institute | Tucson, Arizona, 85745, United States Recruiting Kirsten Bettino 562-693-4477 [email protected] Christopher Chen, MD Principal Investigator
OPN Healthcare | Glendale, California, 91203, United States Recruiting Anthony P Lam, MD 818-507-4732 [email protected] Anthony P Lam, MD Principal Investigator
Redlands Oncology | Redlands, California, 92373, United States Recruiting Patricia Ramos 909-478-7973 [email protected] Emad Ibrahim, MD Principal Investigator
Innovative Clinical Research Institute | Whittier, California, 90603, United States Recruiting John Khoury, MD 562-693-4477 [email protected] John Khoury, MD Principal Investigator
Eastern CT Hematology and Oncology Associates | Norwich, Connecticut, 06360, United States Not yet recruiting Susan Johnson 860-886-8362 [email protected] Dinesh Kapur, MD Principal Investigator
Illinios Cancer Care | Peoria, Illinois, 61615-7828, United States Recruiting Morgan Maddox 309-243-3607 [email protected] SRINIVAS JUJJAVARAPU, MD Principal Investigator
New Jersey Center for Cancer Research | Brick, New Jersey, 08724, United States Not yet recruiting Kari Hamlin 732-840-8880 [email protected] Apurv Agarwal, MD Principal Investigator
Good Samaritan Hospital | Corvallis, Oregon, 97330, United States Recruiting John Strother, MD 541-768-4950 [email protected] John Strother, MD Principal Investigator
Compass Oncology | Portland, Oregon, 97223, United States Recruiting Julian Kern 360-597-1300 [email protected]
Carolina Blood and Cancer Care | Rock Hill, South Carolina, 29732, United States Recruiting Niyathi Nathwani, MD 803-329-7772 [email protected] Niyathi Nathwani, MD Principal Investigator
MD Anderson | Houston, Texas, 77030, United States Not yet recruiting Lorenzo Cohen, PhD 713-792-7734 [email protected] Lorenzo Cohen, PhD Principal Investigator
Northwest Medical Specialty | Tacoma, Washington, 98405, United States Not yet recruiting Jodi Thiel 253-428-8700 [email protected] Frank Senecal, MD Principal Investigator
Location Countries

United States

Verification Date

2021-09-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Attune™

Type: Active Comparator

Description: Attune™ is a completely digital, 10-session, cognitive behavioral therapeutic intervention.

Label: Cerena™

Type: Active Comparator

Description: Cerena™ is a completely digital, 10-session, health education and wellness intervention.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

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