Status:
COMPLETED
CALM: Managing Distress in Malignant Brain Cancer
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
United States Department of Defense
Conditions:
Brain Tumor
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM), compared to treatment as usual (TAU) in those with maligna...
Eligibility Criteria
Inclusion
- Self-reported diagnosis of brain metastasis (bMET) or a malignant primary brain tumor (PBT; specifically grade III or IV and CNS diffuse large B cell lymphomas)\*
- At least 2-weeks post-surgical resection or biopsy of the brain (if applicable)
- Score \> 20 on the TICS
- Reported elevated depression (PHQ-9 score ≥ 10) OR death anxiety symptoms (DADDS score ≥ 15)
- Ability to read, speak, and understand English
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- Major communication difficulties which would prohibit the psychotherapeutic interaction
- Inability to meet with the interventionist via an electronic device for telehealth intervention sessions
- Inability to understand and provide informed consent
- Prisoners
- Medical, psychological, or social condition that, in the opinion of the principal investigator, may increase the participant's risk of adverse events and/or prohibit the individual's participation in the intervention.
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06180460
Start Date
November 10 2023
End Date
September 30 2025
Last Update
October 8 2025
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298