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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

0 / 5Eligibility criteria met