NCT05087095

Managing Distress in Malignant Brain Cancer

Completed NA Results posted Last updated 9 April 2025

What this trial tests

NA trial testing CALM Intervention in Cancer Metastatic to Brain in 13 participants. Completed in 1 November 2023.

Timeline

23 March 2022

Primary endpoint
1 November 2023

1 November 2023

Quick facts

Lead sponsor	Virginia Commonwealth University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	13
Start date	23 March 2022
Primary completion	1 November 2023
Estimated completion	1 November 2023
Sites	1 location across United States

Drugs / interventions tested

• CALM Intervention

Conditions studied

• Cancer Metastatic to Brain — all drugs for Cancer Metastatic to Brain →
• Brain Metastases, Adult — all drugs for Brain Metastases, Adult →

Sponsor

Virginia Commonwealth University

Who can join

18 and older, any sex, with Cancer Metastatic to Brain or Brain Metastases, Adult. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains Primary · 4 Months

At the exit interview, participants will be asked to rate the applicability of the four CALM domains on a Likert Scale from 1 (not applicable) to 5 (very applicable). The four CALM domains are as follows: Domain 1) represents symptom management and communication with healthcare providers, Domain 2) reflects changes in personal relationships, Domain 3) sense of meaning and purpose, and Domain 4) the future, hope and mortality. Higher scores mean greater applicability.

Domain 1

Group	Value	95% CI
CALM	3.2	± 1.2

Domain 2

Group	Value	95% CI
CALM	4.0	± 1.3

Domain 3

Group	Value	95% CI
CALM	4.0	± 1.7

Domain 4

Group	Value	95% CI
CALM	3.5	± 1.3

Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Participant Screening, Eligibility, and Consent. Primary · 12 months

Determine how many patients consent to screening after referral to the program, how many patients are eligible for the program after being screened, and how many consent/enroll in the program if eligible.

Screened

Group	Value	95% CI
CALM	21

Eligible

Group	Value	95% CI
CALM	13

Consented

Group	Value	95% CI
CALM	13

Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Attendance at CALM Sessions Primary · 3 Months

Percent of sessions attended across all participants

Group	Value	95% CI
CALM	76

Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Post-session Assessment Completion Primary · 3 Months

Percent of post-session surveys completed by participants immediately after the intervention

Group	Value	95% CI
CALM	70

Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Post-intervention Assessment Completion Primary · 3 Months

Percent of post-intervention surveys completed

Group	Value	95% CI
CALM	82

Benefit of Intervention in the Proof of Concept Project Primary · 4 Months

Benefit will be assessed by participant responses to a question during the exit interview (e.g., Rate your overall benefit on a scale of 1-5).

Group	Value	95% CI
CALM	4.4	± 0.53

Sponsor's own description

To identify potential adaptations of the managing cancer and living meaningfully (CALM) intervention that will be required for service members, Veterans, their beneficiaries, and civilian cancer metastasis to the brain (bMET) populations.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Managing Cancer and Living Meaningfully in adults with brain metastases: A NIH ORBIT model phase II feasibility and proof-of-concept trial.
   Loughan AR, Lanoye A, Willis K, Braun SE, et al · · 2025 · cited 1× · PMID 40110068 · DOI 10.1093/nop/npae097