Psychological Intervention for Caregivers of Patients With Malignant Gliomas

Study Overview
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Brief Summary
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This research study is evaluating a psychological intervention for caregivers of loved ones with malignant gliomas.

Detailed Description
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Caregivers of loved ones with malignant gliomas frequently experience a physical and psychological burden caring for their loved ones. The purpose of this study is to find out whether a psychological intervention can help caregivers learn effective coping methods during their loved one's treatment and make the experience of being a caregiver more manageable. The psychological intervention will take place in a series of six sessions. A trained social worker or psychologist will meet with the participant or talk with the participant over the telephone or by video conference for 45 minutes at a time to discuss the caregiver experience while developing effective skills to support the loved one as well as the participant over the course of the loved one's illness. Upon the completion of the sessions, the investigators will have a short (30-minute) exit interview to obtain the participant's feedback on the intervention. The investigators will use the feedback to improve the intervention before further testing its effectiveness in future research studies. The investigators will also ask the participant to complete questionnaires before and after their participation in the intervention to help the investigators understand the participant's coping skills, caregiving burden, mood, and understanding about the loved one's illness.

Official Title
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Psychological Intervention for Caregivers of Patients With Malignant Gliomas

Conditions
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Malignant Glioma

Intervention / Treatment
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* Other: Psychological Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Identified by a patient with a malignant glioma (WHO Grade III or IV glioma) as the patient's primary caregiver The patient is receiving care at the MGH Cancer Center The patient was diagnosed with a malignant glioma 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

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychological Intervention<br>Qualitative interview will be conducted 7-item Generalized Anxiety Disorder measure will be completed by participants via mail correspondence or online A psychoeducational component to address preparedness, manage expectations, and develop caregiving skills A psychosocial component focusing on coping strategies, mindfulness, and facilitating acceptance while living with uncertainty A self-care component to promote caregiver health and well-being | Other: Psychological Intervention<br>* Promote effective coping and reduce caregiving burden<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Caregiver Enrollment in the Intervention: Percentage of Eligible Caregivers Who Agree to Participate in the Study of This Intervention | The investigators will report the percentage of eligible caregivers who agree to participate in the study of this intervention. The intervention will be deemed feasible if at least 70% (+/- 18%) of eligible caregivers are enrolled in the study. | 2 years | 
| Feasibility of Caregiver Participation in a Population-specific Psychological Intervention: Percentage of Eligible Caregivers Who Participate in Each Session | The investigators will report the percentage of eligible caregivers who participate in each session. Participation will be considered feasible if at least 70% of enrolled participants complete ≥50% of the sessions. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant Gliomas