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Behavioral Intervention

CALM Therapy for Brain Cancer

N/A
Recruiting
Led By Ashlee Loughan, Ph.D
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Score > 20 on the TICS
Reported elevated depression (PHQ-9 score ≥ 10) OR death anxiety symptoms (DADDS score ≥ 15)
Must not have
Inability to understand and provide informed consent
Inability to meet with the interventionist via an electronic device for telehealth intervention sessions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This trial is testing a therapy called CALM for people with brain cancer. It will compare CALM to the usual treatment that is currently used.

Who is the study for?
This trial is for individuals with malignant brain cancer, who may also have other cancers like kidney, lung, breast, melanoma, or colon cancer. Participants should be interested in a psychotherapeutic approach to manage distress.
What is being tested?
The study compares the effectiveness of a psychotherapy called Managing Cancer and Living Meaningfully (CALM) against the standard treatment practices (TAU) in managing emotional distress in brain cancer patients.
What are the potential side effects?
Since CALM is a psychological therapy focused on reducing stress and improving well-being, it does not have physical side effects like medical treatments. However, discussing sensitive topics could potentially cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My thinking and memory test score is above 20.
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I have significant depression or anxiety about death.
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I have been diagnosed with a severe brain tumor or cancer that has spread to my brain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am able to understand and sign the consent form.
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I cannot use an electronic device for telehealth sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess the acceptability of the CALM intervention- Participant Recommendation Ratings
Assess the acceptability of the CALM intervention- Participant Satisfaction
Assess the feasibility of the CALM intervention- Consent Rate
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Managing Cancer and Living Meaningfully (CALM)Experimental Treatment1 Intervention
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.
Group II: Treatment as Usual (TAU)Placebo Group1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
CALM
2012
Completed Phase 3
~370

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
710 Previous Clinical Trials
22,886,877 Total Patients Enrolled
United States Department of DefenseFED
891 Previous Clinical Trials
332,418 Total Patients Enrolled
Ashlee Loughan, Ph.DPrincipal InvestigatorVirginia Commonwealth University
1 Previous Clinical Trials
60 Total Patients Enrolled
~25 spots leftby Apr 2025
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