NeuroCARE: Psychological Intervention for Caregivers of Patients With Malignant Gliomas (RCT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Malignant Glioma
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Anxiety symptoms
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Deborah A Forst
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •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)
Outcomes
Primary Outcomes
Anxiety symptoms
Time Frame: 11 weeks
We will compare anxiety symptoms using the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS-A) between the intervention and usual care group. The HADS-A is a 7-item subscale with scores ranging from 0 to 21, with higher scores indicating higher levels of anxiety.
Secondary Outcomes
- Self-Efficacy(Up to 16 weeks)
- Anxiety symptoms longitudinally(Up to 16 weeks)
- Quality of life using the Caregiver quality of life oncology questionnaire(Up to 16 weeks)
- Caregiver burden(Up to 16 weeks)
- Coping skills(Up to 16 weeks)
- Depression symptoms(Up to 16 weeks)
- PTSD symptoms(Up to 16 weeks)