NCT04109209

Psychological Intervention For Brain Tumor Caregivers

NeuroCARE: Psychological Intervention for Caregivers of Patients With Malignant Gliomas (RCT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This study will be a prospective, randomized controlled trial to assess the efficacy of a caregiver-directed intervention designed to improve anxiety in caregivers of patients with malignant brain tumors, in comparison with caregivers who receive usual care. The aim of this study is to test the efficacy of this intervention in reducing distress in caregivers of patients with malignant brain tumors, in comparison with usual care. The study will be conducted in 120 caregivers.

Conditions

• Malignant Glioma
• Anxiety
• Caregiver Burden
• Malignant Brain Tumor

Interventions

Type	Name	Description
BEHAVIORAL	Psychosocial Intervention Group	The intervention will consist of six one-on-one sessions (45 minutes each). Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks
BEHAVIORAL	Usual Care Group	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

Timeline

• Start date: 2019-10-09
• Primary completion: 2022-09-13
• Completion: 2022-09-13
• First posted: 2019-09-30
• Last updated: 2024-12-05

Locations

1 site across 1 country: United States