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

NCT04862195 | Terminated DMC

• 1 other identifier: PROT001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 13

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.

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

Outcome Measures

Primary Outcomes (1)

• Cancer-related symptoms of anxiety (1)

  Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety

  Baseline up to Week 10

Secondary Outcomes (5)

• 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

Other Outcomes (4)

• Quality of life via PROMIS-Global Health v1.2

  Weeks 10 and Week 12

• Patient self-efficacy via the Patient Activation Measure-13 (PAM-13)

  Weeks 10

• Patient self-efficacy via the Measurement of Current Status (MOCS) Part A and Part B

  Baseline, Week 6, and Week 10

Study Arms (2)

Attune™

ACTIVE COMPARATOR

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

Device: Attune™

Cerena™

ACTIVE COMPARATOR

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

Device: Cerena™

Interventions

Attune™ DEVICE

Software as a medical device

Attune™

Cerena™ DEVICE

Software as a medical device

Cerena™

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blue Note Therapeutics: lead

Study Sites (13)

OPN Healthcare

Glendale, California, 91203, United States

Location

Oncology Physicians Network Healthcare

Los Alamitos, California, 90720, United States

Location

Redlands Oncology

Redlands, California, 92373, United States

Location

Eastern CT Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Illinios Cancer Care

Peoria, Illinois, 61615-7828, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Rogel Cancer Center | University of Michigan

Ann Arbor, Michigan, 48109-0944, United States

Location

SCL Health

Billings, Montana, 59102, United States

Location

New Jersey Center for Cancer Research

Brick, New Jersey, 08724, United States

Location

New York Cancer & Blood Specialists

Port Jefferson Station, New York, 11776, United States

Location

Tri-County Hematology and Oncology-Massillon

Massillon, Ohio, 44646, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

Northwest Medical Specialty

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Patricia A Ganz, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 27, 2021
• Study Start: May 15, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)