Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices as Adjunctive Oncology Treatment
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|ClinicalTrials.gov Identifier: NCT04862195|
Recruitment Status : Active, not recruiting
First Posted : April 27, 2021
Last Update Posted : April 22, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Device: Attune™ Device: Cerena™||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||May 15, 2021|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||August 2022|
Active Comparator: Attune™
Attune™ is a completely digital, 10-session, cognitive behavioral therapeutic intervention.
Software as a medical device
Active Comparator: Cerena™
Cerena™ is a completely digital, 10-session, health education and wellness intervention.
Software as a medical device
- Cancer-related symptoms of anxiety (1) [ Time Frame: Baseline up to Week 10 ]Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety
- Cancer-related symptoms of depression (1) [ Time Frame: Baseline up to Week 10 ]Percent reduction in PROMIS-D scores, reduction indicates reduced depression
- Cancer-related symptoms of anxiety (2) [ Time Frame: Baseline up to Week 12 ]Percent reduction in PROMIS-A scores, reduction indicates reduced anxiety
- Cancer-related symptoms of anxiety (3) [ Time Frame: Baseline up to Week 10 ]Percent reduction in Clinical Global Impression Scale and Improvement scores, reduction indicates reduced anxiety
- Cancer-related symptoms of depression (4) [ Time Frame: Baseline up to Week 12 ]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 [ Time Frame: Baseline up to Week 10 ]Higher scores indicate higher ease of use / easier to use applications
- Quality of life via PROMIS-Global Health v1.2 [ Time Frame: Weeks 10 and Week 12 ]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.
- Patient self-efficacy via the Patient Activation Measure-13 (PAM-13) [ Time Frame: Weeks 10 ]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.
- Patient self-efficacy via the Measurement of Current Status (MOCS) Part A and Part B [ Time Frame: Baseline, Week 6, and Week 10 ]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.
- Immune cell transcription [ Time Frame: Baseline up to Week 12 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04862195
|United States, California|
|Glendale, California, United States, 91203|
|Oncology Physicians Network Healthcare|
|Los Alamitos, California, United States, 90720|
|Redlands, California, United States, 92373|
|United States, Connecticut|
|Eastern CT Hematology and Oncology Associates|
|Norwich, Connecticut, United States, 06360|
|United States, Illinois|
|Illinios Cancer Care|
|Peoria, Illinois, United States, 61615-7828|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|Rogel Cancer Center | University of Michigan|
|Ann Arbor, Michigan, United States, 48109-0944|
|United States, Montana|
|Billings, Montana, United States, 59102|
|United States, New Jersey|
|New Jersey Center for Cancer Research|
|Brick, New Jersey, United States, 08724|
|United States, New York|
|New York Cancer & Blood Specialists|
|Port Jefferson Station, New York, United States, 11776|
|United States, Ohio|
|Tri-County Hematology and Oncology-Massillon|
|Massillon, Ohio, United States, 44646|
|United States, Texas|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Northwest Medical Specialty|
|Tacoma, Washington, United States, 98405|
|Principal Investigator:||Patricia A Ganz, MD||University of California, Los Angeles|