Clinical trial · Interventional
Managing Distress in Malignant Brain Cancer
NCT05087095CI-TRIAL-00088348completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases, Adult | — | UNRESOLVED | — |
| Cancer Metastatic to Brain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CALM Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CALM
- description
- 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
- interventionNames
- Behavioral: CALM Intervention
Primary outcomes (6)
- measure
- Assess the Need for Adaptations to the CALM Intervention as Measured by the Applicability of the 4 CALM Domains
- timeFrame
- 4 Months
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLoughan AR, Lanoye A, Willis K, Braun SE, Davies A, Rodin G, Thacker L, Fox A, Kleva C, Zarrella G, Mazzeo S, Svikis D, Swartz L. Managing Cancer and Living Meaningfully in adults with brain metastases: A NIH ORBIT model phase II feasibility and proof-of-concept trial. Neurooncol Pract. 2024 Oct 15;12(2):271-280. doi: 10.1093/nop/npae097. eCollection 2025 Apr. PMID 40110068