Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2019-10-09
2022-09-13
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Usual Care Group
* 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
Usual Care Group
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
Psychosocial Intervention Group
* 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
Psychosocial Intervention Group
The intervention will consist of six one-on-one sessions (45 minutes each). Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks
Interventions
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Psychosocial Intervention Group
The intervention will consist of six one-on-one sessions (45 minutes each). Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks
Usual Care Group
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
Eligibility Criteria
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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
* Participated in the pilot study of this caregiver intervention (DF/HCC 18-426)
18 Years
ALL
Yes
Sponsors
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Conquer Cancer Foundation
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Deborah A Forst
Principal Investigator
Principal Investigators
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Deborah Forst, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Countries
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References
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Forst DA, Podgurski AF, Strander SM, Whitman JD, Datta S, Pintro K, Horick NK, Willis KD, Sannes TS, Greer JA, El-Jawahri A, Jacobs JM, Temel JS. NeuroCARE: A Randomized Controlled Trial of a Psychological Intervention for Caregivers of Patients With Primary Malignant Brain Tumors. J Clin Oncol. 2024 Dec 20;42(36):4252-4262. doi: 10.1200/JCO.24.00065. Epub 2024 Sep 16.
Forst DA, Rhee JY, Mesa MM, Podgurski AF, Strander SM, Datta S, Kaslow-Zieve E, Horick NK, Greer JA, El-Jawahri A, Sannes TS, Temel JS, Jacobs J. Study protocol for NeuroCARE: a randomised controlled trial of a psychological intervention for caregivers of patients with primary malignant brain tumours. BMJ Open. 2023 Sep 7;13(9):e069410. doi: 10.1136/bmjopen-2022-069410.
Other Identifiers
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19-250
Identifier Type: -
Identifier Source: org_study_id