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Psychosocial Intervention Group for Caregiver Burden
N/A
Waitlist Available
Led By Deborah Forst, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights
Study Summary
This trial is testing whether a program offering psychological support can help caregivers of people with brain tumors cope better.
Eligible Conditions
- Caregiver Burden
- Anxiety
- Brain Cancer
- Malignant Glioma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anxiety symptoms
Secondary outcome measures
Anxiety
Caregiver burden
Coping skills
+4 moreOther outcome measures
Exploratory Causal Mediation Analysis
Exploratory Moderation Analysis
Intervention Acceptability
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Psychosocial Intervention GroupExperimental Treatment1 Intervention
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
Group II: Usual Care GroupActive Control1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psychosocial Intervention Group
2019
N/A
~120
Find a Location
Who is running the clinical trial?
Conquer Cancer FoundationOTHER
19 Previous Clinical Trials
3,855 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,198,325 Total Patients Enrolled
3 Trials studying Caregiver Burden
650 Patients Enrolled for Caregiver Burden
Deborah Forst, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your score on the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire is 5 or higher, indicating significant anxiety symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care Group
- Group 2: Psychosocial Intervention Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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