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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-randomization, 3, and 6 months after first assessment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 attachment as measured by Experiences in Close Relationships Inventory (ECR-M-16) in the proof of concept project.
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

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

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
690 Previous Clinical Trials
22,884,894 Total Patients Enrolled
United States Department of DefenseFED
856 Previous Clinical Trials
225,580 Total Patients Enrolled
Ashlee Loughan, PhDPrincipal InvestigatorVirginia Commonwealth University
4 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

CALM Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05087095 — N/A
Brain Metastases Research Study Groups: CALM
Brain Metastases Clinical Trial 2023: CALM Intervention Highlights & Side Effects. Trial Name: NCT05087095 — N/A
CALM Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05087095 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives are researchers aiming to fulfill through this trial?

"The primary aim of this 3 month trial is to assess the feasibility of CALM intervention. Secondary outcomes encompass changes in suicidal ideation, as measured by Patient Health Questionnaire-9 (PHQ-9), clinical evaluation via Clinical Evaluation Questionnaire (CEQ) and death distress assessed through Death and Dying Distress Scale (DADDS). PHQ-9 scores range from 0 indicating no depression up to 27 for severe depression, CEQ measures emotional support experienced during treatment with a score between 1 and 5 while DADDS evaluates levels of death anxiety ranging from mild at 25 points and rising to extreme distress above 47."

Answered by AI

Is there any availability to join this health experiment?

"Indeed, according to records on clinicaltrials.gov this ongoing medical trial commenced recruitment on March 23rd 2022 and has recently been updated. The research team is looking for 60 patients from two different locations."

Answered by AI

How many participants are eligible for this clinical trial?

"Affirmative. Clinicaltrials.gov data reveals that this clinical trial is currently recruiting patients, with the initial announcement on March 23rd 2022 and a most recent update made April 5th 2022. The two locations are seeking to enrol 60 participants combined in total."

Answered by AI
~3 spots leftby Sep 2024