Managing Distress in Malignant Brain Cancer

Virginia Commonwealth University13 enrolled

Overview

To identify potential adaptations of the managing cancer and living meaningfully (CALM) intervention that will be required for service members, Veterans, their beneficiaries, and civilian cancer metastasis to the brain (bMET) populations.

Single-arm, mixed-methods, Phase IIa, proof-of-concept trial to inform CALM adaptations for service members (SMs), Veterans, their beneficiaries, and civilians with bMET.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cancer Metastatic to Brain Brain Metastases, Adult

Interventions

CALM InterventionBEHAVIORAL

The CALM intervention includes 6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3 months. Participants will be asked to complete self-report surveys of behavioral and psychological variables surveys at the following timepoints: * Within one week before initiating the CALM intervention therapy * Within one week after its completion, * 3 months after the CALM intervention is complete * After each intervention session, participants will complete a brief post-session survey to assess acceptability of CALM session components

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of brain metastasis (bMET) confirmed via medical records, radiography or histopathology * At least 2 weeks post-surgical cranial resection or cranial biopsy (if applicable) * Score \> 20 on the TICS * Report 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 psychotherapeutic interaction * Inability to meet with interventionist via an electronic device for telehealth intervention sessions * Inability to understand and provide informed consent * Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant's risk

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains

At the exit interview, participants will be asked to rate the applicability of the four CALM domains on a Likert Scale from 1 (not applicable) to 5 (very applicable). The four CALM domains are as follows: Domain 1) represents symptom management and communication with healthcare providers, Domain 2) reflects changes in personal relationships, Domain 3) sense of meaning and purpose, and Domain 4) the future, hope and mortality. Higher scores mean greater applicability.

Time frame: 4 Months

Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Participant Screening, Eligibility, and Consent.

Determine how many patients consent to screening after referral to the program, how many patients are eligible for the program after being screened, and how many consent/enroll in the program if eligible.

Time frame: 12 months

Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Attendance at CALM Sessions

Percent of sessions attended across all participants

Time frame: 3 Months

Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Post-session Assessment Completion

Percent of post-session surveys completed by participants immediately after the intervention

Time frame: 3 Months

Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Post-intervention Assessment Completion

Percent of post-intervention surveys completed

Time frame: 3 Months

Benefit of Intervention in the Proof of Concept Project

Benefit will be assessed by participant responses to a question during the exit interview (e.g., Rate your overall benefit on a scale of 1-5).

Data from ClinicalTrials.gov

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