Clinical trial · Interventional
Psychological Intervention For Brain Tumor Caregivers
NeuroCARE: Psychological Intervention for Caregivers of Patients With Malignant Gliomas (RCT)
- 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)
This study is testing a supportive psychosocial intervention for caregivers of people who have malignant brain tumors such as gliomas or other high-grade primary brain tumors. This study was designed because caregivers of patients with malignant brain tumors often experience physical and psychological burdens caring for their loved ones. The purpose of this study is to find out whether a program offering psychological support can help caregivers learn effective coping methods during their loved one's treatment and make the experience of being a caregiver more manageable.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Caregiver Burden | — | UNRESOLVED | — |
| Malignant Brain Tumor | Malignant Brain Neoplasm | ALIAS | 0.90 |
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psychosocial Intervention Group | Behavioral | — | UNRESOLVED |
| Usual Care Group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Usual Care Group
- description
- * 60 Participants will be randomized to receive usual care for caregivers of patients with malignant brain tumors * Caregivers randomized to the usual care arm will be referred to the brain tumor clinic social worker or other appropriate cancer center resources upon request from the caregiver, patient or clinician * Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks
- interventionNames
- Behavioral: Usual Care Group
- type
- EXPERIMENTAL
- label
- Psychosocial Intervention Group
- description
- * 60 Participants of caregivers of patients with malignant brain tumors will be randomized into the psychosocial intervention arm * Caregivers assigned to the intervention arm will receive usual care and the psychosocial intervention. The intervention entails six one-on-one sessions with an interventionist (psychologist or social worker) * Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks
- interventionNames
- Behavioral: Psychosocial Intervention Group
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 * Identified by study staff, a clinician, self, or a patient with a malignant brain tumor as the patient's primary caregiver * The patient is receiving care at the MGH Cancer Center * The patient was diagnosed with a malignant brain tumor within the past 6 months * Able to speak and read in English * Generalized Anxiety Disorder 7-item (GAD-7) score ≥5 * Participants may or may not be pregnant. Exclusion Criteria: * Deemed inappropriate for the study by the patient's clinician or the study PI * Participated in the pilot study of this caregiver intervention (DF/HCC 18-426)
References
Publications (2)
- DERIVEDForst DA, Podgurski AF, Strander SM, Whitman JD, Datta S, Pintro K, Horick NK, Willis KD, Sannes TS, Greer JA, El-Jawahri A, Jacobs JM, Temel JS. NeuroCARE: A Randomized Controlled Trial of a Psychological Intervention for Caregivers of Patients With Primary Malignant Brain Tumors. J Clin Oncol. 2024 Dec 20;42(36):4252-4262. doi: 10.1200/JCO.24.00065. Epub 2024 Sep 16. PMID 39284103
- DERIVEDForst DA, Rhee JY, Mesa MM, Podgurski AF, Strander SM, Datta S, Kaslow-Zieve E, Horick NK, Greer JA, El-Jawahri A, Sannes TS, Temel JS, Jacobs J. Study protocol for NeuroCARE: a randomised controlled trial of a psychological intervention for caregivers of patients with primary malignant brain tumours. BMJ Open. 2023 Sep 7;13(9):e069410. doi: 10.1136/bmjopen-2022-069410. PMID 37678946