Managing Distress in Malignant Brain Cancer

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Brain Metastases, Adult; Cancer Metastatic to Brain

Treatments: Behavioral: CALM Intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05087095

MCC-21-18040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

13 participants in 1 patient group

CALM

Experimental group

Description:

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

Treatment:

Behavioral: CALM Intervention