Psychological Intervention For Brain Tumor Caregivers

Mass General Brigham

Status: Completed

Conditions: Malignant Brain Tumor; Caregiver Burden; Malignant Glioma; Anxiety

Treatments: Behavioral: Psychosocial Intervention Group; Behavioral: Usual Care Group

Study type: Interventional

Funder types: Other

Identifiers

NCT04109209

19-250

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Usual Care Group

Active Comparator 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

Treatment:

Behavioral: Usual Care Group

Psychosocial Intervention Group

Experimental 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

Treatment:

Behavioral: Psychosocial Intervention Group