CALM: Managing Distress in Malignant Brain Cancer

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giuliana Zarrella; Phone Number: 804-625-4910; Email: zarrellagv@vcu.edu
• Study Contact Backup: Name: Ashlee Loughan, Ph.D; Phone Number: 804-628-6799; Email: ashlee.loughan@vcuhealth.org

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University
      • Contact: Giuliana Zarrella; Phone Number: 804-628-6799; Email: zarrellagv@vcu.edu
      • Contact: Ashlee Loughan, Ph,D; Phone Number: 804-628-6799; Email: ashlee.loughan@vcuhealth.org
      • Principal Investigator: Ashlee Loughan, Ph.D

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Ashlee Loughan, Ph.D, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): July 31, 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 (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Veterans; Service Members
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Neoplasms; Brain Neoplasms
• 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