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OpenTrials
Completed

NCT Number: NCT05087095

Managing Distress in Malignant Brain Cancer

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.

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Key information

Conditions

Cancer Metastatic to Brain Brain Diseases Brain Metastases, Adult Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 3 Months

    Percent of sessions attended across all participants

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

    Time frame: 3 Months

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

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

    Time frame: 3 Months

    Percent of post-intervention surveys completed

  6. Benefit of Intervention in the Proof of Concept Project

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 21, 2021
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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