- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04268979
Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator
February 21, 2024 updated by: H. Lee Moffitt Cancer Center and Research Institute
Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator Intervention for Neuro-Oncology Couples
The purpose of the study is to determine if family caregivers of neuro-oncology patients feel less burdened by utilizing the Electronic Social Network Assessment Program (eSNAP) + the Caregiver Navigator.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
225
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Deanna Witte
- Phone Number: 813-745-2875
- Email: Deanna.Witte@moffitt.org
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33612
- Recruiting
- Moffitt Cancer Center
-
Contact:
- Margaret Byrne, PhD
- Phone Number: 813-745-5569
- Email: Margaret.Byrne@moffitt.org
-
Principal Investigator:
- Margaret Byrne, PhD
-
Sub-Investigator:
- Peter Forsyth, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- English-speaking/reading/writing
- Able to complete questionnaires (including by proxy)
- 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.
- 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
Exclusion Criteria:
- Patients may not participate without a consenting FCG, but FCGs may participate without a consenting patient
- Patients and FCGs who are experiencing acute distress will be excluded from enrollment and referred directly to social work, per Moffitt policy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
---|---|
Experimental: eSNAP & Caregiver Navigator
eSNAP intervention plus questionnaires
|
eSNAP is a web based tool that quickly collects and organizes social support information entered by Family Caregivers (FCGs) into visualizations of the size, quality, and function of support networks.
Visualizations can help FCGs catalogue support resources and present them in a new way, which may make them more salient and remind FCGs of their availability.
Other Names:
The Caregiver Navigator will have social work training and will help Family Caregivers (FCGs) identify and leverage informal and formal social support, including enrolling or directing FCGs to services.
|
No Intervention: Waitlist Control Condition
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Family Caregiver Well-Being Using GAD-7 Scale
Time Frame: 8 weeks per participant
|
Caregiver well being will be measured using the Generalized Anxiety Disorder 7 Item Scale (GAD-7).
The GAD-7 measures anxiety scoring 0-3 points per item, with a total score range 0-21,with a higher score meaning more anxiety.
|
8 weeks per participant
|
Family Caregiver Well-Being using PHQ-8 Scale
Time Frame: 8 weeks per participant
|
Caregiver well being will be measured using the Personal Health Questionnaire Depression 8 Item Scale Scale (PHQ 8).
The PHQ 8 measures depression scoring 0-3 points per item, with a total score range of 0-24, with the higher score meaning more depression.
|
8 weeks per participant
|
Family Caregiver Well-Being Using Zarit Burden Interview
Time Frame: 8 weeks per participant
|
Caregiver well being will be measured using the Zarit Burden Interview.
The Zarit Burden Interview measures burden scoring 0-4 points per item, with a total score range of 0-48, with the higher score meaning more burden.
|
8 weeks per participant
|
Neuro Patients Well-Being Using GAD-7 Scale
Time Frame: 8 weeks per participant
|
Neuro patients well being will be measured using the Generalized Anxiety Disorder 7 Item Scale (GAD-7).
The GAD-7 measures anxiety scoring 0-3 points per item, with a total score range 0-21,with a higher score meaning more anxiety.
|
8 weeks per participant
|
Neuro Patients Well-Being using PHQ-8 Scale
Time Frame: 8 weeks per participant
|
Neuro patients well being will be measured using the Personal Health Questionnaire Depression 8 Item Scale Scale (PHQ 8).
The PHQ 8 measures depression scoring 0-3 points per item, with a total score range of 0-24, with the higher score meaning more depression.
|
8 weeks per participant
|
Neuro Patients Well-Being using NeuroQol
Time Frame: 8 weeks per participant
|
Neuro patients well being will be measured using Neuro-Qol (Neuro Quality of Life) which will be using T scores where the lower values represent worse outcomes.
|
8 weeks per participant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Margaret Byrne, PhD, Moffitt Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 13, 2020
Primary Completion (Estimated)
April 14, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
February 11, 2020
First Submitted That Met QC Criteria
February 12, 2020
First Posted (Actual)
February 13, 2020
Study Record Updates
Last Update Posted (Estimated)
February 22, 2024
Last Update Submitted That Met QC Criteria
February 21, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC 19731
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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