Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices as Adjunctive Oncology Treatment
Public ClinicalTrials.gov record NCT04862195. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04862195
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 31 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 15, 2021 (Actual)
- Primary completion
- Sep 1, 2022 (Actual)
- Completion
- Sep 1, 2022 (Actual)
- Last update posted
- Sep 13, 2022
2021 – 2022
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| OPN Healthcare | Glendale | California | 91203 | — |
| Oncology Physicians Network Healthcare | Los Alamitos | California | 90720 | — |
| Redlands Oncology | Redlands | California | 92373 | — |
| Eastern CT Hematology and Oncology Associates | Norwich | Connecticut | 06360 | — |
| Illinios Cancer Care | Peoria | Illinois | 61615-7828 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Rogel Cancer Center | University of Michigan | Ann Arbor | Michigan | 48109-0944 | — |
| SCL Health | Billings | Montana | 59102 | — |
| New Jersey Center for Cancer Research | Brick | New Jersey | 08724 | — |
| New York Cancer & Blood Specialists | Port Jefferson Station | New York | 11776 | — |
| Tri-County Hematology and Oncology-Massillon | Massillon | Ohio | 44646 | — |
| MD Anderson | Houston | Texas | 77030 | — |
| Northwest Medical Specialty | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04862195, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 13, 2022 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04862195 live on ClinicalTrials.gov.