Managing Distress in Malignant Brain Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Managing Distress in Malignant Brain Cancer

Conditions
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Cancer Metastatic to Brain, Brain Metastases, Adult

Intervention / Treatment
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* Behavioral: CALM Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CALM<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the need for adaptations to the CALM intervention by conducting exit interviews and performing thematic analysis on interview data in proof of concept project. | Exit interviews will be audio recorded and transcribed verbatim via Dragon Software. A co- investigator and a second independent coder will separately review each transcript to identify common themes and develop a coding framework of free responses. All results will be reviewed for agreement and comparison to the raw data, and discrepancies will be resolved through discussion with the PI until reliability is reached (Kappa>.80). | 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 | 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 follow-up assessment completion | Percent of follow-up surveys completed by participants three months after the intervention | 6 Months | 
| Benefit of intervention in the Proof of concept project as measured by participant responses to researcher-developed questions as part of the exit interview | Benefit will be assessed by participant responses to questions during the exit interview (e.g., Rate your overall benefit on a scale of 1-5). It will also be assessed by the likelihood of recommending the program to others (Would you recommend this program to others- why or why not?). | 7 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bMET, CALM, Service Members, Veterans