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This study was halted prematurely due to slow enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attune™ | Active Comparator | Attune™ is a completely digital, 10-session, cognitive behavioral therapeutic intervention. |
|
| Cerena™ | Active Comparator | Cerena™ is a completely digital, 10-session, health education and wellness intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attune™ | Device | Software as a medical device |
| |
| Cerena™ |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-related symptoms of anxiety (1) | Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety | Baseline up to Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-related symptoms of depression (1) | Percent reduction in PROMIS-D scores, reduction indicates reduced depression | Baseline up to Week 10 |
| Cancer-related symptoms of anxiety (2) | Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life via PROMIS-Global Health v1.2 | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia A Ganz, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OPN Healthcare | Glendale | California | 91203 | United States | ||
| Oncology Physicians Network Healthcare |
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| Device |
Software as a medical device |
|
| Baseline up to Week 12 |
| Cancer-related symptoms of anxiety (3) | Percent reduction in Clinical Global Impression Scale and Improvement scores, reduction indicates reduced anxiety | Baseline up to Week 10 |
| Cancer-related symptoms of depression (4) | Percent reduction in Clinical Global Impression Scale and Improvement scores, reduction indicates reduced depression | Baseline up to Week 12 |
| Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients | Higher scores indicate higher ease of use / easier to use applications | Baseline up to Week 10 |
| Weeks 10 and Week 12 |
| Patient self-efficacy via the Patient Activation Measure-13 (PAM-13) | 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. | Weeks 10 |
| Patient self-efficacy via the Measurement of Current Status (MOCS) Part A and Part B | 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. | Baseline, Week 6, and Week 10 |
| Immune cell transcription | 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 | Baseline up to Week 12 |
| Los Alamitos |
| California |
| 90720 |
| United States |
| Redlands Oncology | Redlands | California | 92373 | United States |
| Eastern CT Hematology and Oncology Associates | Norwich | Connecticut | 06360 | United States |
| Illinios Cancer Care | Peoria | Illinois | 61615-7828 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Rogel Cancer Center | University of Michigan | Ann Arbor | Michigan | 48109-0944 | United States |
| SCL Health | Billings | Montana | 59102 | United States |
| New Jersey Center for Cancer Research | Brick | New Jersey | 08724 | United States |
| New York Cancer & Blood Specialists | Port Jefferson Station | New York | 11776 | United States |
| Tri-County Hematology and Oncology-Massillon | Massillon | Ohio | 44646 | United States |
| MD Anderson | Houston | Texas | 77030 | United States |
| Northwest Medical Specialty | Tacoma | Washington | 98405 | United States |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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