CALM: Managing Distress in Malignant Brain Cancer

October 2, 2025 updated by: Virginia Commonwealth University

Managing Distress in Malignant Brain Cancer - Phase IIc RCT

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion 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

Exclusion 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Managing Cancer and Living Meaningfully (CALM)
CALM optimally consists of six individual sessions of 45 to 60 minutes, delivered over a three- to six-month period. CALM sessions address four broad and interrelated domains found to be important and relevant in this population: (1) symptom management and communication with healthcare providers, (2) changes in personal relationships, (3) sense of meaning and purpose, and (4) the future, hope and mortality.
Behavioral: CALM
The CALM intervention is a supportive-expressive therapy that is administered by CALM trained clinicians in a particular style.
Placebo Comparator: Treatment as Usual (TAU)
Treatment as usual (TAU) for managing distress in brain cancer involves being provided a list of local / national resources (e.g., psychologist, social worker, or other mental health providers) if an individual chooses to seek treatment for the distress they are experiencing.
Behavioral: Treatment as usual
Treatment as usual includes a list of local / national resources (e.g., psychologist, social worker, or other mental health providers) if an individual chooses to seek treatment for the distress they are experiencing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the feasibility of the CALM intervention- Screening Rate
Time Frame: Day 0
Percent of interested individuals who undergo screening
Day 0
Assess the feasibility of the CALM intervention- Consent Rate
Time Frame: Day 0
Percent of eligible individuals who consent to the trial
Day 0
Assess the feasibility of the CALM intervention- Intervention Retention Rate
Time Frame: 3 months
Percent of consented individuals who complete the CALM intervention
3 months
Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate
Time Frame: 3 months
Percent of consented individuals who complete post-intervention questionnaires
3 months
Assess the feasibility of the CALM intervention- Follow-up Questionnaire Completion Rate
Time Frame: 6 months
Percent of consented individuals who complete follow-up questionnaires
6 months
Assess the acceptability of the CALM intervention- Participant Satisfaction
Time Frame: 4 months
Satisfaction ratings from participants during exit interview (e.g., Rate your overall benefit on a scale of 1-5).
4 months
Assess the acceptability of the CALM intervention- Participant Recommendation Ratings
Time Frame: 4 months
Percent of participants who would recommendation CALM to others will be assessed during the exit interview (e.g., Would you recommend this program to others?)
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Ashlee Loughan, Ph.D, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2023

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 22, 2023

Study Record Updates

Last Update Posted (Estimated)

October 8, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-23-20816

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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