Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator

Not Applicable

Active, not recruiting

• Conditions: Brain Cancer
• Interventions: Behavioral: eSNAP; Behavioral: Caregiver Navigator

• Registration Number: NCT04268979
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-12
• Study Start: 2020-02-13
• Study First Posted: 2020-02-13
• Primary Completion: 2024-07-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 296

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eSNAP & Caregiver Navigator	eSNAP	eSNAP intervention plus questionnaires
eSNAP & Caregiver Navigator	Caregiver Navigator	eSNAP intervention plus questionnaires

Primary Outcome Measures

Name	Time	Method
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.
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 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.
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.
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.
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.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States