Managing Distress in Malignant Brain Cancer

Not Applicable

Completed

• Conditions: Brain Metastases, Adult; Cancer Metastatic to Brain
• Interventions: Behavioral: CALM Intervention

• Registration Number: NCT05087095
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-21
• Study Start: 2022-03-23
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01
• Results First Submitted: 2024-11-05
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Results First Posted: 2025-04-09
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CALM	CALM Intervention	CALM therapy will be provided via telehealth. Participants will complete surveys (post-session, post-intervention, and 90-day follow-up) via secure email link. Exit interviews will be conducted by phone

Primary Outcome Measures

Name	Time	Method
Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains	4 Months	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.
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Attendance at CALM Sessions	3 Months	Percent of sessions attended across all participants
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Participant Screening, Eligibility, and Consent.	12 months	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.
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Post-session Assessment Completion	3 Months	Percent of post-session surveys completed by participants immediately after the intervention
Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Post-intervention Assessment Completion	3 Months	Percent of post-intervention surveys completed
Benefit of Intervention in the Proof of Concept Project	4 Months	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).

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States