Psychological Intervention For Brain Tumor Caregivers
NeuroCARE: Psychological Intervention for Caregivers of Patients With Malignant Gliomas (RCT)
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2019
CompletedFirst Posted
Study publicly available on registry
September 30, 2019
CompletedStudy Start
First participant enrolled
October 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2022
CompletedDecember 5, 2024
December 1, 2024
2.9 years
September 26, 2019
December 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Anxiety symptoms longitudinally
Up to 16 weeks
Self-Efficacy
Up to 16 weeks
Coping skills
Up to 16 weeks
Quality of life using the Caregiver quality of life oncology questionnaire
Up to 16 weeks
Caregiver burden
Up to 16 weeks
- +2 more secondary outcomes
Other Outcomes (3)
Intervention Acceptability
11 weeks
Exploratory Moderation Analysis
Up to 16 weeks
Exploratory Causal Mediation Analysis
Up to 16 weeks
Study Arms (2)
Usual Care Group
ACTIVE COMPARATOR* 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
Psychosocial Intervention Group
EXPERIMENTAL* 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
Interventions
The intervention will consist of six one-on-one sessions (45 minutes each). Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks
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
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Conquer Cancer Foundationcollaborator
Study Sites (1)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Related Publications (2)
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.
PMID: 39284103DERIVEDForst 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.
PMID: 37678946DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah Forst, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 26, 2019
First Posted
September 30, 2019
Study Start
October 9, 2019
Primary Completion
September 13, 2022
Study Completion
September 13, 2022
Last Updated
December 5, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.