Clinical trial NCT03026699: Refining and Testing the Electronic Social Network Assessment Program (eSNAP)
Official title: Refining and Testing the Electronic Social Network Assessment Program (eSNAP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Cancer
Keywords: Brain
Nervous system
Neuro-oncology
Caregivers
Cancer patient
Family caregivers
Brain tumors
Quality of life
Stress
Social support
Feasibility
Electronic Social Network Assessment Program (eSNAP)
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Utah
name: National Cancer Institute (NCI)
First posted: 2017-01-20
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be family caregivers recruited from the Moffitt Cancer Center Radiation Oncology Clinic.

Brief summary: The purpose of the study is to learn more about neuro-oncology caregivers' quality of life and how friends and families help neuro-oncology cancer caregivers at different times during treatment.

Detailed description: Former Aim 1: Refine eSNAP data-gathering and visualization prototypes based on evaluations of user experience, including usability, satisfaction and applicability. The refining process was completed at the University of Utah.

Aim 2: Test the feasibility of implementing eSNAP in a neuro-oncology clinical setting and collect preliminary effectiveness data of eSNAP on Family Caregiver outcomes, including quality of life and stress, and mediators (Family Caregiver social support utilization and burden). The feasibility process will take place at Moffitt Cancer Center.

This study will be a 2x2 longitudinal design. Caregivers of primary brain tumor patients will be compared to caregivers of patients with secondary brain tumors (brain metastases) to determine if there is something unique about the cancer-specific duties of primary versus secondary brain tumors that could impact the effectiveness of the eSNAP application. An intervention group will be compared to a control group for both types of caregivers. Participants will be randomized 2:1 for the intervention and control. All caregivers will be followed for 6 weeks and will be asked to complete questionnaires at 3 time points; caregivers in the intervention group will also be asked to use the eSNAP application at time 1, which will be available to them for the duration of the study.

Eligibility criteria: Inclusion Criteria:

* Family caregiver of a patient with primary or secondary brain tumor
* Age 18 years or older
* Able to speak and write English

Exclusion Criteria:

* Does not meet the Inclusion Criteria

Primary outcomes:
measure: Questionnaire Participation Among Participant Groups
timeFrame: 6 weeks per participant
measure: Retention of Participants Among Participant Groups
timeFrame: 6 weeks per participant
Secondary outcomes:
measure: Stress and Coping - Quality of Life Among Participant Groups
timeFrame: 6 weeks per participant
measure: Perceived Social Support - Quality of Life Among Participant Groups
timeFrame: 6 weeks per participant
measure: Incidence of Clinic Disruption
timeFrame: 6 weeks per participant
measure: Incidence of Problems with eSNAP implementation
timeFrame: 6 weeks per participant
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Maija Reblin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reblin M, Ketcher D, Forsyth P, Mendivil E, Kane L, Pok J, Meyer M, Wu YP, Agutter J. Feasibility of implementing an electronic social support and resource visualization tool for caregivers in a neuro-oncology clinic. Support Care Cancer. 2018 Dec;26(12):4199-4206. doi: 10.1007/s00520-018-4293-z. Epub 2018 Jun 12.