NCT06180460Completed
CALM: Managing Distress in Malignant Brain Cancer
Managing Distress in Malignant Brain Cancer - Phase IIc RCT
Source: ClinicalTrials.gov · Last updated 8 Oct 2025
Brief summary (registry, in English)
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 malignant brain cancer diagnoses.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 12 Dec 2023
- Start date
- 10 Nov 2023
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Virginia Commonwealth University
- NCT number
- NCT06180460
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 10 Nov 2023 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.