Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator

Overview

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.

Full Title of Study: “Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator Intervention for Neuro-Oncology Couples”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2022

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: eSNAP & Caregiver Navigator
    • eSNAP intervention plus questionnaires
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Family Caregiver Well-Being Using GAD-7 Scale
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

  • English-speaking/reading/writing
  • Able to complete questionnaires (including by proxy)
  • Family Caregivers (FCGs) must self-identify as being a primary FCG pf a patient with a malignant brain tumor. (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 malignant brain tumor within the last 6 months, be pursuing active treatment at Moffitt (i.e. not second opinion consultation), have a prognosis of at least 6 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.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • H. Lee Moffitt Cancer Center and Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Maija Reblin, PhD, Principal Investigator, Moffitt Cancer Center
  • Overall Contact(s)
    • Maija Reblin, PhD, 813-745-8705, Maija.Reblin@moffitt.org

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