Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator

Brain Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04268979
• Other study ID #: MCC 19731
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 13, 2020
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 296
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	8 weeks per participant
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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