Clinical trial · Interventional
Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers
Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers (AIM 2)
NCT05590273CI-TRIAL-00066115AIM 2terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient caregiver participation
Summary
Brief summary (as posted)
To conduct a mixed-method Phase Ia Define Trial of caregivers' participation in CALM therapy with post-session surveys and individual exit interviews in order to evaluate suitability and adapt the CALM intervention to the needs of caregivers in neuro-oncology.
Conditions
Conditions (3)
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 |
| Caregivers | — | UNRESOLVED | — |
| Neuro-Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CALM Therapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proof-of-concept trial
- description
- Inform CALM adaptations for caregivers of patients with brain cancer.
- interventionNames
- Behavioral: CALM Therapy
Primary outcomes (2)
- measure
- Evaluate suitability of the CALM intervention to the needs of caregivers in neuro-oncology by measuring caregiver satisfaction.
- timeFrame
- 3 months
- description
- Utilizing post-session surveys, determine caregiver satisfaction (5-point Likert Scale) with 1) topic applicability; 2) perceived benefit of session; 3) comfort with interventionist(s); 4) overall satisfaction and 5) likelihood of recommending the program to others. Higher scores represent greater caregiver satisfaction with the CALM intervention.
- measure
- Evaluate suitability of the CALM intervention to the needs of caregivers in neuro-oncology by measuring caregivers' recommendations to the content and format of the intervention during an exit-interview.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Caregiver participants must be the caregiver of a brain cancer patient who is currently enrolled in DoD CA200896 (IRBHM20022755) * Fluent in English * Willing and able to attend a minimum of 3 CALM sessions via telehealth * A caregiver is defined as the primary person who provides ongoing support to the brain cancer patient; it is not necessary that the caregiver lives with the patient or is related * Patient participants must have enrolled in the linked HM20022755 study Exclusion Criteria: * Person does not consider themselves to be a caregiver of the patient * Caregiver does not have a loved one (patient diagnosed with brain cancer) enrolled in DoDCA200896 (IRB HM20022755) * Caregiver does not speak English * Caregiver is unable to provide consent * Caregiver does not have access to telehealth * Caregiver is under the age of 18 * Professional caregivers who received financial compensation for their services are ineligible
References
Publications (0)
Data not yet available
No reference posted for this study.