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CALM Intervention for Brain Cancer

N/A

Waitlist Available

Led By Ashlee Loughan, PhD

Research Sponsored by Virginia Commonwealth University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 2 weeks post-surgical cranial resection or cranial biopsy (if applicable)

Diagnosis of brain metastasis (bMET) confirmed via medical records, radiography or histopathology

Must not have

Inability to meet with interventionist via an electronic device for telehealth intervention sessions

Inability to understand and provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-randomization, 3, and 6 months after first assessment

Awards & highlights

No Placebo-Only Group

Summary

This trial will help to identify how the CALM intervention can be adapted to help service members, Veterans, and civilians who have cancer that has spread to the brain.

Who is the study for?

This trial is for individuals with confirmed brain metastasis who have undergone any necessary surgery at least two weeks prior. Participants must exhibit signs of depression or death anxiety, be able to communicate in English, and consent to the study. Those with major communication issues, unable to use telehealth services, or with conditions that increase risk as per investigator's judgment cannot join.

What is being tested?

The trial is testing the CALM intervention designed to help manage distress in patients with malignant brain cancer. It aims to adapt this approach for military personnel, veterans, their dependents, and civilians suffering from brain metastases.

What are the potential side effects?

Since the CALM intervention involves psychological support rather than medication, typical drug side effects are not expected. However, discussing sensitive topics may evoke emotional discomfort or heightened distress temporarily.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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It has been over 2 weeks since my brain surgery or biopsy.

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My medical records confirm I have brain metastasis.

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My thinking and memory test score is above 20.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot use an electronic device for telehealth sessions.

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I am able to understand and sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-randomization, 3, and 6 months after first assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-randomization, 3, and 6 months after first assessment

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-randomization, 3, and 6 months after first assessment 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 need for adaptations to the CALM intervention by conducting exit interviews and performing thematic analysis on interview data in proof of concept project.

Benefit of intervention in the Proof of concept project as measured by participant responses to researcher-developed questions as part of the exit interview

Feasibility of CALM intervention in the Proof of Concept project as measured by attendance at CALM sessions

+3 more

Secondary study objectives

Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in attachment as measured by Experiences in Close Relationships Inventory (ECR-M-16) in the pilot trial

Repeated measures will assess changes within groups across time (pre-intervention, post-intervention, follow-up) in clinical evaluation as measured by the Clinical Evaluation Questionnaire (CEQ) in the pilot trial

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CALMExperimental Treatment1 Intervention

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

0 / 5Eligibility criteria met