Managing Distress in Malignant Brain Cancer - Ph II Randomized Crontrolled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Managing Distress in Malignant Brain Cancer - Phase IIc RCT

Conditions
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Brain Tumor, Brain Metastases, Brain Cancer, Metastatic Lung Cancer, Metastatic Breast Cancer, Metastatic Melanoma, Metastatic Colon Cancer, Metastatic Kidney Cancer

Intervention / Treatment
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* Behavioral: CALM
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported diagnosis of brain metastasis (bMET) or a grade III or IV primary brain tumor ( PBT)* 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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Managing Cancer and Living Meaningfully (CALM)<br>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. | Behavioral: CALM<br>* The CALM intervention is a supportive-expressive therapy that is administered by CALM trained clinicians in a particular style.<br>|
| Placebo Comparator: Treatment as Usual (TAU)<br>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. | Behavioral: Treatment as usual<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the feasibility of the CALM intervention- Screening Rate | Percent of interested individuals who undergo screening | Day 0 | 
| Assess the feasibility of the CALM intervention- Consent Rate | Percent of eligible individuals who consent to the trial | Day 0 | 
| Assess the feasibility of the CALM intervention- Intervention Retention Rate | Percent of consented individuals who complete the CALM intervention | 3 months | 
| Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate | Percent of consented individuals who complete post-intervention questionnaires | 3 months | 
| Assess the feasibility of the CALM intervention- Follow-up Questionnaire Completion Rate | Percent of consented individuals who complete follow-up questionnaires | 6 months | 
| Assess the acceptability of the CALM intervention- Participant Satisfaction | Satisfaction ratings from participants during exit interview (e.g., Rate your overall benefit on a scale of 1-5). | 4 months | 
| Assess the acceptability of the CALM intervention- Participant Reccomendation Ratings | 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?) | 4 months | 

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