CALM: Managing Distress in Malignant Brain Cancer

NCT06180460 | Completed

• 1 other identifier: MCC-23-20816
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 malignant brain cancer diagnoses.

Conditions

Brain Tumor; Brain Metastases; Brain Cancer; Metastatic Lung Cancer; Metastatic Breast Cancer; Metastatic Melanoma; Metastatic Colon Cancer; Metastatic Kidney Cancer

Keywords

Service Members; Veterans

Outcome Measures

Primary Outcomes (7)

• Assess the feasibility of the CALM intervention- Screening Rate

  Percent of interested individuals who undergo screening

  Day 0

• Assess the feasibility of the CALM intervention- Consent Rate

  Percent of eligible individuals who consent to the trial

  Day 0

• Assess the feasibility of the CALM intervention- Intervention Retention Rate

  Percent of consented individuals who complete the CALM intervention

  3 months

• Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate

  Percent of consented individuals who complete post-intervention questionnaires

  3 months

• Assess the feasibility of the CALM intervention- Follow-up Questionnaire Completion Rate

  Percent of consented individuals who complete follow-up questionnaires

  6 months

• Assess the acceptability of the CALM intervention- Participant Satisfaction

  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

  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

Study Arms (2)

Managing Cancer and Living Meaningfully (CALM)

EXPERIMENTAL

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

Treatment as Usual (TAU)

PLACEBO COMPARATOR

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

Interventions

CALM BEHAVIORAL

The CALM intervention is a supportive-expressive therapy that is administered by CALM trained clinicians in a particular style.

Managing Cancer and Living Meaningfully (CALM)

Treatment as usual BEHAVIORAL

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.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Lung Neoplasms; Breast Neoplasms; Melanoma; Colonic Neoplasms; Kidney Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Ashlee Loughan, Ph.D

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: November 10, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 8, 2025

Record last verified: 2025-10

Locations

US (1)