Status:
RECRUITING
Evaluating Digital Micro-Interventions to Reduce Distress and Increase Wellbeing in Breast Cancer Survivors
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Mental Health Issue
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Digital mental and behavioral health interventions have potential to significantly improve accessibility for the large number of breast cancer survivors who need treatments. However, the landscape of ...
Eligibility Criteria
Inclusion
- Age = 18 years.
- 0-5 years post-diagnosis of Stage I, II, or III female breast cancer.
- Elevated symptoms of depression and/or anxiety as measured by the PHQ-8 (score \> 9) or GAD-7 (score \> 7).
Exclusion
- Receiving individual (1 on 1) treatment for depression and/or anxiety to avoid treatment interference (note, individuals will be permitted to enroll if they are taking antidepressant medication and have not had an appointment to adjust the dosage over the past 2 weeks)
- Active suicidal ideation during the enrollment/screening call based on a trained staff member orally administering the suicidality item from the PHQ-9 to individuals on the phone ("In the last 2 weeks, have you had thoughts that you would be better off dead, or thoughts of hurting yourself in some way?"). If an individual responds in any way other than "not at all" based on the available response options (i.e., either "several days", "more than half the days", or "nearly every day"), or if they mention having suicidal ideation or thoughts of death during the enrollment/screening call, the Pitt-Optimum risk assessment tool will be administered. Only participants deemed low risk may proceed in enrollment; all will be given additional resources.
- Do not have an app-compatible phone (i.e., iOS 10.3 or later or Android 4.0.3 or later).
- Cannot read and speak English (interventions only available in English).
Key Trial Info
Start Date :
August 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07160439
Start Date
August 12 2025
End Date
June 30 2026
Last Update
October 3 2025
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22904