Clinical trial · Interventional
CALM: Managing Distress in Malignant Brain Cancer
Managing Distress in Malignant Brain Cancer - Phase IIc RCT
NCT06180460CI-TRIAL-00096406completedN/AClinicalTrials.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)
The purpose of this study is to test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM), compared to treatment as usual (TAU) in those with malignant brain cancer diagnoses.
Conditions
Conditions (8)
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 Cancer | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Brain Metastases | — | UNRESOLVED | — |
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Kidney Cancer | Malignant Kidney Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CALM | Behavioral | — | UNRESOLVED |
| Treatment as usual | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Managing Cancer and Living Meaningfully (CALM)
- description
- CALM optimally consists of six individual sessions of 45 to 60 minutes, delivered over a three- to six-month period. CALM sessions address four broad and interrelated domains found to be important and relevant in this population: (1) symptom management and communication with healthcare providers, (2) changes in personal relationships, (3) sense of meaning and purpose, and (4) the future, hope and mortality.
- interventionNames
- Behavioral: CALM
- type
- PLACEBO_COMPARATOR
- label
- Treatment as Usual (TAU)
- description
- Treatment as usual (TAU) for managing distress in brain cancer involves being provided a list of local / national resources (e.g., psychologist, social worker, or other mental health providers) if an individual chooses to seek treatment for the distress they are experiencing.
- interventionNames
- Behavioral: Treatment as usual
Primary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Self-reported diagnosis of brain metastasis (bMET) or a malignant primary brain tumor (PBT; specifically grade III or IV and CNS diffuse large B cell lymphomas)\* * At least 2-weeks post-surgical resection or biopsy of the brain (if applicable) * Score \> 20 on the TICS * Reported 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 the psychotherapeutic interaction * Inability to meet with the interventionist via an electronic device for telehealth intervention sessions * Inability to understand and provide informed consent * Prisoners * Medical, psychological, or social condition that, in the opinion of the principal investigator, may increase the participant's risk of adverse events and/or prohibit the individual's participation in the intervention.
References
Publications (0)
Data not yet available
No reference posted for this study.