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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06180460
Other study ID # MCC-23-20816
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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