Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator

NCT04268979 | Completed Results

• 2 other identifiers: MCC 197315R01CA236034-05
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Cancer

Keywords

Neuro Oncology

Outcome Measures

Primary Outcomes (6)

• 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. 50 indicates the population mean with a standard deviation of 10.

  8 weeks per participant

Study Arms (2)

eSNAP & Caregiver Navigator

EXPERIMENTAL

eSNAP intervention plus questionnaires

Behavioral: eSNAP; Behavioral: Caregiver Navigator

Waitlist Control Condition

NO 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.

Interventions

eSNAP BEHAVIORAL

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.

Also known as: Electronic Social Network Assessment Program

eSNAP & Caregiver Navigator

Caregiver Navigator BEHAVIORAL

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.

eSNAP & Caregiver Navigator

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (2)

• 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.

  PMID: 41198147 DERIVED

• 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.

  PMID: 33865382 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Margaret Byrne, Ph.D.
• Organization: Moffitt Cancer Center

Margaret.Byrne@moffitt.org

813-745-5569

Study Officials

• Margaret Byrne, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: February 13, 2020
• Primary Completion: July 3, 2024
• Study Completion: September 13, 2024
• Last Updated: February 20, 2026
• Results First Posted: October 14, 2025

Record last verified: 2026-02

Locations

US (1)