CALM: Managing Distress in Malignant Brain Cancer

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Brain Metastases; Metastatic Kidney Cancer; Brain Tumor; Metastatic Melanoma; Metastatic Breast Cancer; Metastatic Colon Cancer; Brain Cancer; Metastatic Lung Cancer

Treatments: Behavioral: CALM; Behavioral: Treatment as usual

Study type: Interventional

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

Identifiers

NCT06180460

MCC-23-20816

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Managing Cancer and Living Meaningfully (CALM)

Experimental group

Description:

CALM optimally consists of six individual sessions of 45 to 60 minutes, delivered over a three- to six-month period. CALM sessions address four broad and interrelated domains found to be important and relevant in this population: (1) symptom management and communication with healthcare providers, (2) changes in personal relationships, (3) sense of meaning and purpose, and (4) the future, hope and mortality.

Treatment:

Behavioral: CALM

Treatment as Usual (TAU)

Placebo Comparator group

Description:

Treatment as usual (TAU) for managing distress in brain cancer involves being provided 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.

Treatment:

Behavioral: Treatment as usual