Psychological Intervention For Brain Tumor Caregivers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malignant Glioma, Anxiety, Caregiver Burden, Malignant Brain Tumor

Intervention / Treatment
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* Behavioral: Psychosocial Intervention Group
* Behavioral: Usual Care Group


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care Group<br>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 | Behavioral: Usual Care Group<br>* 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<br>|
| Experimental: Psychosocial Intervention Group<br>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 | Behavioral: Psychosocial Intervention Group<br>* The intervention will consist of six one-on-one sessions (45 minutes each). Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety symptoms | 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. | 11 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety symptoms longitudinally | We will compare anxiety symptoms using the Anxiety subscale of the hospital anxiety and depression scale (HADS-A) between the two groups longitudinally. HADS-A is the 7-item anxiety subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating higher levels of anxiety. | Up to 16 weeks | 
| Self-Efficacy | Comparison of the effect of the intervention on caregiver self-efficacy (CASE) between study groups . The Lewis Cancer Self-Efficacy Scale (CASE) is a 17-item scale that measures caregivers' confidence in managing the impact of their loved one's illness from. Score range from 0 to 170. Higher scores indicate higher self-efficacy. | Up to 16 weeks | 
| Coping skills | We will compare coping skills between study arms using the Measure of Current Status Part A (MOCS-A). The MOCS-A assesses caregivers' self-perceived status on coping skills targeted by the intervention. Total MOCS-A scores range from 0-52 with higher scores indicating better self-perceived coping skills. | Up to 16 weeks | 
| Quality of life using the Caregiver quality of life oncology questionnaire | Comparison of caregiver quality of life (CarGOQoL) between study groups. The CareGiver Oncology QoL questionnaire (CarGOQoL) is a 29-item, well-validated instrument specific to caregivers for patients with cancer, used to measure family caregiver QoL in multiple domains. Overall scores range from 0 to 100, with higher scores corresponding to higher quality of life. | Up to 16 weeks | 
| Caregiver burden | Comparison of caregiver burden (CRA) between study groups. - Caregiving burden will be measured using the Caregiver Reaction Assessment (CRA), a 24-item scale measuring caregiving burden with score range of 24-120. Higher scores indicate higher caregiving burden. | Up to 16 weeks | 
| Depression symptoms | Comparison of the effect of the intervention on depression symptoms (HADS-D) between study groups. HADS-D is the 7-item depression subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating higher levels of depression. | Up to 16 weeks | 
| PTSD symptoms | Comparison of post-traumatic stress disorder (PTSD) symptoms between study groups . PTSD symptoms will be measured using the PCL-5, a 20-item questionnaire with scores ranging from 0-80; higher scores indicate more severe PTSD symptoms. | Up to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant Glioma, Caregiver Anxiety, Caregiver Burden, Psychological distress, Brain Tumor