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Clinical Trial 19731

Cancer Type: Neurologic Oncology
Study Type: Supportive Care
NCT#: NCT04268979

Phase: N/A
Prinicipal Investigator: Margaret Byrne

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Study Title

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


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.


Aim 1. Determine the efficacy of eSNAP + Navigator support intervention on FCG well-being. H1: FCGs of patients with primary malignant brain tumor who receive the intervention will report less perceived burden and distress when compared with waitlist controls at the Week 8 follow-up. Aim 2. Determine the efficacy of eSNAP + Navigator on patient well-being and health care utilization. H1: Patients whose FCGs receive the intervention will be less distressed and will have fewer unscheduled outpatient visits and hospitalizations when compared with waitlist controls at the Week 8 follow-up. Exploratory Aim 3. Identify key intervention components using mixed methods to inform future intervention implementation. Quantitative analysis will identify timing and dosing effects of the intervention and key mechanisms from the conceptual model, including FCG heath care utilization. Qualitative analysis of FCG interviews about intervention effectiveness will augment quantitative analysis.




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, 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.

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.