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Trial record 2 of 16 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | Brain Tumor | United States | First posted from 01/01/2020 to 06/24/2020

Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04268979
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Brain Cancer Behavioral: eSNAP Behavioral: Caregiver Navigator Not Applicable

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Study Type : Interventional
Estimated 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 : February 10, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


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 Name: 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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268979


Contacts
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Contact: Maija Reblin, PhD 813-745-8705 Maija.Reblin@moffitt.org

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Maija Reblin, PhD    813-745-8705    Maija.Reblin@mofffitt.org   
Sub-Investigator: Margaret Byrne, PhD         
Sub-Investigator: Peter Forsyth, MD         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
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Principal Investigator: Maija Reblin, PhD Moffitt Cancer Center
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT04268979    
Other Study ID Numbers: MCC 19731
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Neuro Oncology
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases