Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04268979

Enrollment

296

Registered

2020-02-13

Start date

2020-02-13

Completion date

2024-09-13

Last updated

2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Cancer

Keywords

Neuro Oncology

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.

Interventions

BEHAVIORALeSNAP

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.

BEHAVIORALCaregiver 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Family Caregiver Well-Being Using GAD-7 Scale	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.
Family Caregiver Well-Being Using PHQ-8 Scale	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.
Family Caregiver Well-Being Using Zarit Burden Interview	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.
Neuro Patients Well-Being Using GAD-7 Scale	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.
Neuro Patients Well-Being Using PHQ-8 Scale	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.
Neuro Patients Well-Being Using NeuroQol	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. 50 indicates the population mean with a standard deviation of 10.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMargaret Byrne, PhD

Moffitt Cancer Center

Participant flow

Participants by arm

Arm	Count
Family Caregivers Family caregivers (FCGs) of patients with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease.	148
Neuro Patients Patients diagnosed with a new or recurrent primary brain tumor, a secondary (metastatic) brain tumor, or leptomeningeal disease within the last 9 months, and receiving at least some evaluation and/or care at Moffitt.	148
Total	296

Baseline characteristics

Characteristic	Family Caregivers	Total	Neuro Patients
Age, Continuous	57.1 years	57.7 years	58.2 years
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) Black or African American	4 Participants	10 Participants	6 Participants
Race (NIH/OMB) More than one race	5 Participants	5 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	26 Participants	35 Participants	9 Participants
Race (NIH/OMB) White	113 Participants	244 Participants	131 Participants
Region of Enrollment United States	148 participants	296 participants	148 participants
Sex: Female, Male Female	87 Participants	155 Participants	68 Participants
Sex: Female, Male Male	37 Participants	117 Participants	80 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

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.