Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator

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

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: Completed
• Conditions: Brain Cancer
• Intervention / Treatment: Behavioral: eSNAP; Behavioral: Caregiver Navigator

• Study Type: Interventional
• Enrollment (Actual): 296
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

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 leptomeningeal 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eSNAP & Caregiver Navigator; eSNAP intervention plus questionnaires	Behavioral: eSNAP; 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: Electronic Social Network Assessment Program; Behavioral: Caregiver Navigator; 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	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 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
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
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. 50 indicates the population mean with a standard deviation of 10.	8 weeks per participant

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Margaret Byrne, PhD, Moffitt Cancer Center

Publications and helpful links

General Publications

• Reblin M, Ketcher D, McCormick R, Barrios-Monroy V, Sutton SK, Zebrack B, Wells KJ, Sahebjam S, Forsyth P, Byrne MM. A randomized wait-list controlled trial of a social support intervention for caregivers of patients with primary malignant brain tumor. BMC Health Serv Res. 2021 Apr 17;21(1):360. doi: 10.1186/s12913-021-06372-w.
• Reblin M, Wells KJ, Zebrack BJ, Witte D, Byrne MM. Associations of Critical Relationships With Distress and Burden in Caregivers of Patients With Brain Tumor. Psychooncology. 2025 Nov;34(11):e70332. doi: 10.1002/pon.70332.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Actual): July 3, 2024
• Study Completion (Actual): September 13, 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 (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Neuro Oncology
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: MCC 19731; 5R01CA236034-05 (U.S. NIH Grant/Contract)

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