N/A
N=13
Managing Distress in Malignant Brain Cancer
Cancer Metastatic to Brain · Brain Metastases, Adult
Bottom Line
View on ClinicalTrials.gov: NCT05087095 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains — 3.2; 4.0; 4.0; 3.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CALM Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains |
3.2; 4.0; 4.0; 3.5 | — |
| PRIMARY Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Participant Screening, Eligibility, and Consent. |
21; 13; 13 | — |
| PRIMARY Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Attendance at CALM Sessions |
76 | — |
| PRIMARY Feasibility of CALM Intervention in the Proof of Concept Project as Measured by the Rates of Post-session Assessment Completion |
70 | — |
| PRIMARY Feasibility of CALM Intervention in the Proof of Concept Project as Measured by Post-intervention Assessment Completion |
82 | — |
| PRIMARY Benefit of Intervention in the Proof of Concept Project |
4.4 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of brain metastasis (bMET) confirmed via medical records, radiography or histopathology
- At least 2 weeks post-surgical cranial resection or cranial biopsy (if applicable)
- Score > 20 on the TICS
- Report elevated depression (PHQ-9 score ≥ 10) OR death anxiety symptoms (DADDS score ≥ 15)
- Ability to read, speak, and understand English
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- Major communication difficulties, which would prohibit psychotherapeutic interaction
- Inability to meet with interventionist via an electronic device for telehealth intervention sessions
- Inability to understand and provide informed consent
- Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant's risk
Data sourced from ClinicalTrials.gov (NCT05087095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.