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

Primary Purpose

Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attune™
Cerena™
Sponsored by
Blue Note Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anatomic Stage I Breast Cancer AJCC v8

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • OPN Healthcare
  • Oncology Physicians Network Healthcare
  • Redlands Oncology
  • Eastern CT Hematology and Oncology Associates
  • Illinios Cancer Care
  • Massachusetts General Hospital
  • Rogel Cancer Center | University of Michigan
  • SCL Health
  • New Jersey Center for Cancer Research
  • New York Cancer & Blood Specialists
  • Tri-County Hematology and Oncology-Massillon
  • MD Anderson
  • Northwest Medical Specialty

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Attune™

Cerena™

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cancer-related symptoms of anxiety (1)
Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety

Secondary Outcome Measures

Cancer-related symptoms of depression (1)
Percent reduction in PROMIS-D scores, reduction indicates reduced depression
Cancer-related symptoms of anxiety (2)
Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety
Cancer-related symptoms of anxiety (3)
Percent reduction in Clinical Global Impression Scale and Improvement scores, reduction indicates reduced anxiety
Cancer-related symptoms of depression (4)
Percent reduction in Clinical Global Impression Scale and Improvement scores, reduction indicates reduced depression
Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients
Higher scores indicate higher ease of use / easier to use applications

Full Information

First Posted
April 19, 2021
Last Updated
September 8, 2022
Sponsor
Blue Note Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT04862195
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
This study was halted prematurely due to slow enrollment
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blue Note Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attune™
Arm Type
Active Comparator
Arm Description
Attune™ is a completely digital, 10-session, cognitive behavioral therapeutic intervention.
Arm Title
Cerena™
Arm Type
Active Comparator
Arm Description
Cerena™ is a completely digital, 10-session, health education and wellness intervention.
Intervention Type
Device
Intervention Name(s)
Attune™
Intervention Description
Software as a medical device
Intervention Type
Device
Intervention Name(s)
Cerena™
Intervention Description
Software as a medical device
Primary Outcome Measure Information:
Title
Cancer-related symptoms of anxiety (1)
Description
Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety
Time Frame
Baseline up to Week 10
Secondary Outcome Measure Information:
Title
Cancer-related symptoms of depression (1)
Description
Percent reduction in PROMIS-D scores, reduction indicates reduced depression
Time Frame
Baseline up to Week 10
Title
Cancer-related symptoms of anxiety (2)
Description
Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety
Time Frame
Baseline up to Week 12
Title
Cancer-related symptoms of anxiety (3)
Description
Percent reduction in Clinical Global Impression Scale and Improvement scores, reduction indicates reduced anxiety
Time Frame
Baseline up to Week 10
Title
Cancer-related symptoms of depression (4)
Description
Percent reduction in Clinical Global Impression Scale and Improvement scores, reduction indicates reduced depression
Time Frame
Baseline up to Week 12
Title
Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients
Description
Higher scores indicate higher ease of use / easier to use applications
Time Frame
Baseline up to Week 10
Other Pre-specified Outcome Measures:
Title
Quality of life via PROMIS-Global Health v1.2
Description
The PROMIS Global Health measures assess an individual's physical, mental, and social health. The measures are generic, rather than disease-specific, and often use an "In General" item context as it is intended to globally reflect individuals' assessment of their health. The adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health (Promis-Global Health Scoring Manual, 2017). Higher scores for responses always indicate better health.
Time Frame
Weeks 10 and Week 12
Title
Patient self-efficacy via the Patient Activation Measure-13 (PAM-13)
Description
Patient Activation Measures-the knowledge, skills, and confidence to manage one's health is associated with improved self-management behaviors in cancer patients. A patient activation measure (PAM) using PAM-13 will be used to assess participant engagement at baseline after PROMIS-A and PROMIS-D are completed and at Week 10. Higher scores indicate higher self-efficacy.
Time Frame
Weeks 10
Title
Patient self-efficacy via the Measurement of Current Status (MOCS) Part A and Part B
Description
The Measure of Current Status (MOCS) scale comes from research on the effects of a multi-modal cognitive-behavioral stress management intervention on the psychosocial well-being of cancer patients. The MOCS has two sections. Part A is items measuring participants' current self-perceived status on several skills that are targeted by the intervention: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Part B assesses potential "nonspecific effects" of the intervention: feelings of normalcy vs. alienation, sense of cohesiveness with other patients, perceptions of care from persons around them, and a sense of being better off than other cancer patients. All items were framed in such a way that they are sensible to participants in both conditions. MOCS measurements will be taken at Baseline, Week 6, and Week 10. Higher scores indicate higher self-efficacy.
Time Frame
Baseline, Week 6, and Week 10
Title
Immune cell transcription
Description
Analyses will focus on inflammatory gene expression and related gene regulation pathways due to their established relevance for disease progression/recurrence in the aftermath of cancer diagnosis and treatment, and their role in promoting symptoms of depression or anxiety via effects on central nervous system function
Time Frame
Baseline up to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia A Ganz, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
OPN Healthcare
City
Glendale
State/Province
California
ZIP/Postal Code
91203
Country
United States
Facility Name
Oncology Physicians Network Healthcare
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Redlands Oncology
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Facility Name
Eastern CT Hematology and Oncology Associates
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Illinios Cancer Care
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615-7828
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Rogel Cancer Center | University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0944
Country
United States
Facility Name
SCL Health
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
New Jersey Center for Cancer Research
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
New York Cancer & Blood Specialists
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Facility Name
Tri-County Hematology and Oncology-Massillon
City
Massillon
State/Province
Ohio
ZIP/Postal Code
44646
Country
United States
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Northwest Medical Specialty
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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