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Completed

NCT Number: NCT06180460

CALM: Managing Distress in Malignant Brain Cancer

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.

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Key information

Conditions

Brain Tumor Brain Cancer Brain Diseases Brain Metastases Brain Neoplasms Breast Diseases Breast Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Metastatic Breast Cancer Metastatic Colon Cancer Metastatic Kidney Cancer Metastatic Lung Cancer Metastatic Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic 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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

CALM

Behavioral

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

Treatment as Usual

Behavioral

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.

Primary outcomes

  1. Assess the feasibility of the CALM intervention- Screening Rate

    Time frame: Day 0

    Percent of interested individuals who undergo screening

  2. Assess the feasibility of the CALM intervention- Consent Rate

    Time frame: Day 0

    Percent of eligible individuals who consent to the trial

  3. Assess the feasibility of the CALM intervention- Intervention Retention Rate

    Time frame: 3 months

    Percent of consented individuals who complete the CALM intervention

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

    Time frame: 3 months

    Percent of consented individuals who complete post-intervention questionnaires

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

    Time frame: 6 months

    Percent of consented individuals who complete follow-up questionnaires

  6. Assess the acceptability of the CALM intervention- Participant Satisfaction

    Time frame: 4 months

    Satisfaction ratings from participants during exit interview (e.g., Rate your overall benefit on a scale of 1-5).

  7. Assess the acceptability of the CALM intervention- Participant Recommendation Ratings

    Time frame: 4 months

    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?)

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Managing Distress in Malignant Brain Cancer - Phase IIc RCT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 22, 2023
Registry last updated
Oct 8, 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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