CALM: Managing Distress in Malignant Brain Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

Managing Distress in Malignant Brain Cancer - Phase IIc RCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180460
• Other study ID #: MCC-23-20816
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: February 2024
• Source: Virginia Commonwealth University
• Contact: Giuliana Zarrella
• Phone: 804-625-4910
• Email: zarrellagv[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Cancer
• Brain Metastases
• Brain Neoplasms
• Brain Tumor
• Kidney Neoplasms
• Metastatic Breast Cancer
• Metastatic Colon Cancer
• Metastatic Kidney Cancer
• Metastatic Lung Cancer
• Metastatic Melanoma

Intervention

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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the feasibility of the CALM intervention- Screening Rate	Percent of interested individuals who undergo screening	Day 0
Primary	Assess the feasibility of the CALM intervention- Consent Rate	Percent of eligible individuals who consent to the trial	Day 0
Primary	Assess the feasibility of the CALM intervention- Intervention Retention Rate	Percent of consented individuals who complete the CALM intervention	3 months
Primary	Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate	Percent of consented individuals who complete post-intervention questionnaires	3 months
Primary	Assess the feasibility of the CALM intervention- Follow-up Questionnaire Completion Rate	Percent of consented individuals who complete follow-up questionnaires	6 months
Primary	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
Primary	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