- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04109209
Psychological Intervention For Brain Tumor Caregivers
NeuroCARE: Psychological Intervention for Caregivers of Patients With Malignant Gliomas (RCT)
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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 |
Experimental: Psychosocial Intervention Group
|
The intervention will consist of six one-on-one sessions (45 minutes each).
Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety symptoms
Time Frame: 11 weeks
|
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
Time Frame: Up to 16 weeks
|
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
Time Frame: Up to 16 weeks
|
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
Time Frame: Up to 16 weeks
|
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
Time Frame: Up to 16 weeks
|
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
Time Frame: Up to 16 weeks
|
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
Time Frame: Up to 16 weeks
|
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
Time Frame: Up to 16 weeks
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention Acceptability
Time Frame: 11 weeks
|
For participants who are assigned to the intervention arm, we will use the Client Satisfaction Questionnaire (CSQ-3), a three-item questionnaire designed to evaluate satisfaction with provision, quality, and outcome of services, to assess participant acceptability of the NeuroCARE intervention.
Total scores on the CSQ-3 range from 4-12, with higher numbers indicating a higher level of satisfaction with the services provided.
|
11 weeks
|
Exploratory Moderation Analysis
Time Frame: Up to 16 weeks
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As an exploratory analysis, we will assess whether age, sex, and baseline anxiety moderate the effect of the intervention on caregiver reported outcomes
|
Up to 16 weeks
|
Exploratory Causal Mediation Analysis
Time Frame: Up to 16 weeks
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Exploratory causal mediation analysis to explore whether caregiver self-efficacy and coping skills mediate the effect of the intervention on caregiver anxiety symptoms.
|
Up to 16 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Deborah Forst, MD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Stress, Psychological
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Glioma
- Brain Neoplasms
- Caregiver Burden
Other Study ID Numbers
- 19-250
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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