CALM: Managing Distress in Malignant Brain Cancer

Not Applicable

Active, not recruiting

• Conditions: Metastatic Melanoma; Brain Metastases; Metastatic Colon Cancer; Metastatic Lung Cancer; Brain Tumor; Brain Cancer; Metastatic Breast Cancer; Metastatic Kidney Cancer
• Interventions: Behavioral: CALM; Behavioral: Treatment as usual

• Registration Number: NCT06180460
• Lead Sponsor: Virginia Commonwealth University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-10
• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-12
• Study First Posted: 2023-12-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-29
• Last Update Posted: 2025-05-30
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Managing Cancer and Living Meaningfully (CALM)	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.
Treatment as Usual (TAU)	Treatment as usual	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.

Primary Outcome Measures

Name	Time	Method
Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate	3 months	Percent of consented individuals who complete post-intervention questionnaires
Assess the feasibility of the CALM intervention- Consent Rate	Day 0	Percent of eligible individuals who consent to the trial
Assess the feasibility of the CALM intervention- Screening Rate	Day 0	Percent of interested individuals who undergo screening
Assess the feasibility of the CALM intervention- Follow-up Questionnaire Completion Rate	6 months	Percent of consented individuals who complete follow-up questionnaires
Assess the feasibility of the CALM intervention- Intervention Retention Rate	3 months	Percent of consented individuals who complete the CALM intervention
Assess the acceptability of the CALM intervention- Participant Satisfaction	4 months	Satisfaction ratings from participants during exit interview (e.g., Rate your overall benefit on a scale of 1-5).
Assess the acceptability of the CALM intervention- Participant Recommendation Ratings	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?)

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States