Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator

Sponsor
H. Lee Moffitt Cancer Center and Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04268979
Collaborator
(none)
225
1
2
52.5
4.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: eSNAP
  • Behavioral: Caregiver Navigator
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
225 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator Intervention for Neuro-Oncology Couples
Actual Study Start Date :
Feb 13, 2020
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: eSNAP & Caregiver Navigator

eSNAP intervention plus questionnaires

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.
Other Names:
  • Electronic Social Network Assessment Program
  • 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.

    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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. 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 within the last 6 months, receiving at least some evaluation and/or care at Moffitt (i.e. at least one appointment), 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Moffitt Cancer Center Tampa Florida United States 33612

    Sponsors and Collaborators

    • H. Lee Moffitt Cancer Center and Research Institute

    Investigators

    • Principal Investigator: Margaret Byrne, PhD, Moffitt Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    H. Lee Moffitt Cancer Center and Research Institute
    ClinicalTrials.gov Identifier:
    NCT04268979
    Other Study ID Numbers:
    • MCC 19731
    First Posted:
    Feb 13, 2020
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by H. Lee Moffitt Cancer Center and Research Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 22, 2022