CALM: Managing Distress in Malignant Brain Cancer

Virginia Commonwealth University60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

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

Interventions

CALMBEHAVIORAL

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

Treatment as usualBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Assess the feasibility of the CALM intervention- Screening Rate

Percent of interested individuals who undergo screening

Time frame: Day 0

Assess the feasibility of the CALM intervention- Consent Rate

Percent of eligible individuals who consent to the trial

Time frame: Day 0

Assess the feasibility of the CALM intervention- Intervention Retention Rate

Percent of consented individuals who complete the CALM intervention

Time frame: 3 months

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

Percent of consented individuals who complete post-intervention questionnaires

Time frame: 3 months

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

Percent of consented individuals who complete follow-up questionnaires

Time frame: 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).

Time frame: 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?)

Time frame: 4 months

Data from ClinicalTrials.gov

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