Clinical trial NCT04109209: Psychological Intervention For Brain Tumor Caregivers
Official title: NeuroCARE: Psychological Intervention for Caregivers of Patients With Malignant Gliomas (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Glioma
Anxiety
Caregiver Burden
Malignant Brain Tumor
Keywords: Malignant Glioma
Caregiver Anxiety
Caregiver Burden
Psychological distress
Brain Tumor
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Conquer Cancer Foundation
First posted: 2019-09-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Anxiety symptoms
timeFrame: 11 weeks
Secondary outcomes:
measure: Anxiety symptoms longitudinally
timeFrame: Up to 16 weeks
measure: Self-Efficacy
timeFrame: Up to 16 weeks
measure: Coping skills
timeFrame: Up to 16 weeks
measure: Quality of life using the Caregiver quality of life oncology questionnaire
timeFrame: Up to 16 weeks
measure: Caregiver burden
timeFrame: Up to 16 weeks
measure: Depression symptoms
timeFrame: Up to 16 weeks
measure: PTSD symptoms
timeFrame: Up to 16 weeks
Other outcomes:
measure: Intervention Acceptability
timeFrame: 11 weeks
measure: Exploratory Moderation Analysis
timeFrame: Up to 16 weeks
measure: Exploratory Causal Mediation Analysis
timeFrame: Up to 16 weeks
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Deborah Forst, MD
role: PRINCIPAL_INVESTIGATOR
References: