Refining and Testing the Electronic Social Network Assessment Program (eSNAP)

Completed

• Conditions: Brain Cancer
• Interventions: Behavioral: eSNAP; Behavioral: Questionnaires

• Registration Number: NCT03026699
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Study Timeline

• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-20
• Study Start: 2017-05-05
• Primary Completion: 2017-10-17
• Study Completion: 2017-10-17
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention - Primary Brain Tumor	Questionnaires	eSNAP Intervention Plus Questionnaires: Family caregivers of primary brain tumor patients.
Control - Primary Brain Tumor	Questionnaires	Questionnaires Only Control: Family caregivers of primary brain tumor patients.
Control - Secondary Brain Tumor	Questionnaires	Questionnaires Only Control: Family caregivers of secondary brain tumor patients.
Intervention - Primary Brain Tumor	eSNAP	eSNAP Intervention Plus Questionnaires: Family caregivers of primary brain tumor patients.
Intervention - Secondary Brain Tumor	Questionnaires	eSNAP Intervention Plus Questionnaires: Family caregivers of secondary brain tumor patients.
Intervention - Secondary Brain Tumor	eSNAP	eSNAP Intervention Plus Questionnaires: Family caregivers of secondary brain tumor patients.

Primary Outcome Measures

Name	Time	Method
Questionnaire Participation Among Participant Groups	6 weeks per participant	Feasibility 1: Recruitment rates per group.
Retention of Participants Among Participant Groups	6 weeks per participant	Feasibility 2: Retention rates per group.

Secondary Outcome Measures

Name	Time	Method
Stress and Coping - Quality of Life Among Participant Groups	6 weeks per participant	Although not reaching adequate power to detect differences, planned analysis will allow investigators to estimate effect size of eSNAP at baseline as well as the effect of cancer type. (Power analysis conducted in G\*Power for ANOVA using effect size 0.2 a=.05 for 3 groups for power of 0.80 requires a sample of 246.) ANOVA will be conducted to determine if groups vary on stress and quality of life at baseline. Growth-curve analysis will be used to identify potential preliminary differences in the eSNAP group over time.
Perceived Social Support - Quality of Life Among Participant Groups	6 weeks per participant	Chi square and generalized linear model (GLM) will be used to analyze utilization of support services differences.
Incidence of Clinic Disruption	6 weeks per participant	Incidence of clinic disruption per participant group.
Incidence of Problems with eSNAP implementation	6 weeks per participant	Chi square and generalized linear model (GLM) will be used to analyze trends in satisfaction or time spent on ecomapping/eSNAP.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States