Managing Distress in Malignant Brain Cancer

NCT05087095 | Completed Results DMC

• 1 other identifier: MCC-21-18040
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Metastatic to Brain; Brain Metastases, Adult

Keywords

bMET; CALM; Service Members; Veterans

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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

  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

  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

  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).

  4 Months

Study Arms (1)

CALM

EXPERIMENTAL

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

Behavioral: CALM Intervention

Interventions

CALM Intervention BEHAVIORAL

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

CALM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• Loughan AR, Lanoye A, Willis K, Braun SE, Davies A, Rodin G, Thacker L, Fox A, Kleva C, Zarrella G, Mazzeo S, Svikis D, Swartz L. Managing Cancer and Living Meaningfully in adults with brain metastases: A NIH ORBIT model phase II feasibility and proof-of-concept trial. Neurooncol Pract. 2024 Oct 15;12(2):271-280. doi: 10.1093/nop/npae097. eCollection 2025 Apr.

  PMID: 40110068 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Ashlee Loughan, PhD, LCP
• Organization: Virginia Commonwealth University

ashlee.loughan@vcuhealth.org

804-828-9815

Study Officials

• Ashlee Loughan, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: October 21, 2021
• Study Start: March 23, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 9, 2025
• Results First Posted: April 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)