Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator

Study Overview
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Brief Summary
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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.

Official Title
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Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator Intervention for Neuro-Oncology Couples

Conditions
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Brain Cancer

Intervention / Treatment
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* Behavioral: eSNAP
* Behavioral: Caregiver Navigator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eSNAP & Caregiver Navigator<br>eSNAP intervention plus questionnaires | Behavioral: eSNAP<br>* 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.<br>* Other names: Electronic Social Network Assessment Program;Behavioral: Caregiver Navigator<br>* 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.<br>|
| No Intervention: Waitlist Control Condition<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Family Caregiver Well-Being Using GAD-7 Scale | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuro Oncology