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Digital Support System for Brain Cancer Caregivers
N/A
Recruiting
Led By Margaret Byrne, PhD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be diagnosed with new or recurrent primary brain tumor, a secondary (metastatic) brain tumor or leptominingeal disease within the last 9 months, receiving at least some evaluation and/or care at Moffitt (i.e. at least one appointment), have a prognosis of at least 9 months
Family Caregivers (FCGs) must self-identify as being a primary FCG of a patient with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease diagnosis. A primary caregiver is a family member, friend, or other unpaid person who provides at least some care for a patient at home.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks per participant
Awards & highlights
Study Summary
This trial is testing whether a digital support system can reduce caregiver burden for families of brain cancer patients.
Who is the study for?
This trial is for English-speaking family caregivers of patients with new or recurrent primary brain tumors, secondary brain tumors, or leptomeningeal disease diagnosed within the last 9 months. Caregivers must be providing care at home and able to complete questionnaires. Patients should have visited Moffitt at least once and have a life expectancy of over 9 months.Check my eligibility
What is being tested?
The study tests if using the Electronic Social Network Assessment Program (eSNAP) along with a Caregiver Navigator helps reduce the burden on family caregivers of neuro-oncology patients.See study design
What are the potential side effects?
Since this trial involves an assessment program and support service rather than medical treatment, traditional physical side effects are not applicable. However, participants may experience emotional or psychological responses to engagement with these tools.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with a brain tumor or leptomeningeal disease in the last 9 months and have a life expectancy of at least 9 months.
Select...
I am the main person helping someone with a brain tumor without being paid.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks per participant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks per participant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Family Caregiver Well-Being Using GAD-7 Scale
Family Caregiver Well-Being Using Zarit Burden Interview
Family Caregiver Well-Being using PHQ-8 Scale
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: eSNAP & Caregiver NavigatorExperimental Treatment2 Interventions
eSNAP intervention plus questionnaires
Group II: Waitlist Control ConditionActive Control1 Intervention
Participants randomly assigned to the waitlist control condition will only complete questionnaires during the 8-week study period. After the 8 weeks, they will then have access to the eSNAP, including completion of questionnaires and 8 weeks of Caregiver Navigator sessions as needed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
eSNAP
2017
N/A
~70
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
540 Previous Clinical Trials
135,210 Total Patients Enrolled
Margaret Byrne, PhDPrincipal InvestigatorMoffitt Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with a brain tumor or leptomeningeal disease in the last 9 months and have a life expectancy of at least 9 months.I am the main person helping someone with a brain tumor without being paid.
Research Study Groups:
This trial has the following groups:- Group 1: eSNAP & Caregiver Navigator
- Group 2: Waitlist Control Condition
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.
To what extent is enrollment being taken for this trial?
"Affirmative. According to clinicaltrials.gov, this investigation is still searching for trial participants - the study was initially announced on February 13th 2020 and modified most recently on August 18th 2022. The research center aims to include 225 individuals in total at a single centre of recruitment."
Answered by AI
Are there any opportunities for people to participate in this experiment?
"According to the relevant clinicaltrials.gov page, this medical study is recruiting participants from its initial posting on February 13th 2020 until August 18th 2022."
Answered by AI
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