An interventional study of CALM and Treatment as usual in Brain Tumor, Brain Metastases and Brain Cancer, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-08.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Supportive care
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.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 60 is above the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
The CALM intervention is a supportive-expressive therapy that is administered by CALM trained clinicians in a particular style.
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.
Assess the feasibility of the CALM intervention- Screening Rate
Percent of interested individuals who undergo screening
Time frame: Day 0
Assess the feasibility of the CALM intervention- Consent Rate
Percent of eligible individuals who consent to the trial
Time frame: Day 0
Assess the feasibility of the CALM intervention- Intervention Retention Rate
Percent of consented individuals who complete the CALM intervention
Time frame: 3 months
Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate
Percent of consented individuals who complete post-intervention questionnaires
Time frame: 3 months
Assess the feasibility of the CALM intervention- Follow-up Questionnaire Completion Rate
Percent of consented individuals who complete follow-up questionnaires
Time frame: 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).
Time frame: 4 months
Assess the acceptability of the CALM intervention- Participant Recommendation 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?)
Time frame: 4 months
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Virginia Commonwealth University