Clinical trial NCT04862195: Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices as Adjunctive Oncology Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Stage I Lung Cancer AJCC v8
Stage II Lung Cancer AJCC v8
Stage III Lung Cancer AJCC v8
Lead sponsor: Blue Note Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-04-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Cancer-related symptoms of anxiety (1)
timeFrame: Baseline up to Week 10
Secondary outcomes:
measure: Cancer-related symptoms of depression (1)
timeFrame: Baseline up to Week 10
measure: Cancer-related symptoms of anxiety (2)
timeFrame: Baseline up to Week 12
measure: Cancer-related symptoms of anxiety (3)
timeFrame: Baseline up to Week 10
measure: Cancer-related symptoms of depression (4)
timeFrame: Baseline up to Week 12
measure: Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients
timeFrame: Baseline up to Week 10
Other outcomes:
measure: Quality of life via PROMIS-Global Health v1.2
timeFrame: Weeks 10 and Week 12
measure: Patient self-efficacy via the Patient Activation Measure-13 (PAM-13)
timeFrame: Weeks 10
measure: Patient self-efficacy via the Measurement of Current Status (MOCS) Part A and Part B
timeFrame: Baseline, Week 6, and Week 10
measure: Immune cell transcription
timeFrame: Baseline up to Week 12
Locations:
city: Glendale
country: United States
facility: OPN Healthcare
state: California
city: Los Alamitos
country: United States
facility: Oncology Physicians Network Healthcare
state: California
city: Redlands
country: United States
facility: Redlands Oncology
state: California
city: Norwich
country: United States
facility: Eastern CT Hematology and Oncology Associates
state: Connecticut
city: Peoria
country: United States
facility: Illinios Cancer Care
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: Rogel Cancer Center | University of Michigan
state: Michigan
city: Billings
country: United States
facility: SCL Health
state: Montana
city: Brick
country: United States
facility: New Jersey Center for Cancer Research
state: New Jersey
city: Port Jefferson Station
country: United States
facility: New York Cancer & Blood Specialists
state: New York
city: Massillon
country: United States
facility: Tri-County Hematology and Oncology-Massillon
state: Ohio
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: Tacoma
country: United States
facility: Northwest Medical Specialty
state: Washington
Study officials:
affiliation: University of California, Los Angeles
name: Patricia A Ganz, MD
role: PRINCIPAL_INVESTIGATOR
References: