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CompletedNot applicableNCT06180460
Official study title

CALM: Managing Distress in Malignant Brain Cancer

Study 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 malignant brain cancer diagnoses.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedCALM and Treatment as usual

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 8, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Virginia Commonwealth University

Study sponsor

01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Not applicable
Sponsor
Virginia Commonwealth University
Interventions being studied
Behavioral: CALM; Behavioral: Treatment as usual
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting
Metastatic or stage IV→
Treatment approach
Supportive or behavioral care→
Study topics
Brain metastases→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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
Reasons someone may not be able to joinExclusion criteria
  • 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Virginia Commonwealth UniversityRichmond, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 8, 2025. Always confirm current availability with the study team.

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