Spots Global Cancer Trial Database for Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices as Adjunctive Oncology Treatment
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Trial Identification
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 ID: NCT04862195
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
OPN Healthcare, Glendale, California, United States
Oncology Physicians Network Healthcare, Los Alamitos, California, United States
Redlands Oncology, Redlands, California, United States
Eastern CT Hematology and Oncology Associates, Norwich, Connecticut, United States
Illinios Cancer Care, Peoria, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Rogel Cancer Center | University of Michigan, Ann Arbor, Michigan, United States
SCL Health, Billings, Montana, United States
New Jersey Center for Cancer Research, Brick, New Jersey, United States
New York Cancer & Blood Specialists, Port Jefferson Station, New York, United States
Tri-County Hematology and Oncology-Massillon, Massillon, Ohio, United States
MD Anderson, Houston, Texas, United States
Northwest Medical Specialty, Tacoma, Washington, United States
Contact Details
Name: Patricia A Ganz, MD
Affiliation: University of California, Los Angeles
Role: PRINCIPAL_INVESTIGATOR
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