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

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.

Study Overview

• Status: Completed
• Conditions: Brain Cancer
• Intervention / Treatment: Behavioral: eSNAP; Behavioral: Questionnaires

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 Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants will be family caregivers recruited from the Moffitt Cancer Center Radiation Oncology Clinic.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention - Primary Brain Tumor; eSNAP Intervention Plus Questionnaires: Family caregivers of primary brain tumor patients.	Behavioral: eSNAP; Participants in the intervention group will then be given a tablet loaded with the eSNAP application and asked to create a visualization of their social networks. Upon completion, participants will be asked to review their ecomaps and complete the user experience questionnaire.; Other Names: Electronic Social Network Assessment Program; Behavioral: Questionnaires; Participants will complete demographics and baseline (T1; baseline) questionnaires. For all participants Time 2 (T2; 3 week) and Time 3 (T3; 6 week) questionnaires will be completed either by phone, mail, or email (depending on participant preference) to assess longer-term effects of eSNAP on outcomes versus controls.
Intervention - Secondary Brain Tumor; eSNAP Intervention Plus Questionnaires: Family caregivers of secondary brain tumor patients.	Behavioral: eSNAP; Participants in the intervention group will then be given a tablet loaded with the eSNAP application and asked to create a visualization of their social networks. Upon completion, participants will be asked to review their ecomaps and complete the user experience questionnaire.; Other Names: Electronic Social Network Assessment Program; Behavioral: Questionnaires; Participants will complete demographics and baseline (T1; baseline) questionnaires. For all participants Time 2 (T2; 3 week) and Time 3 (T3; 6 week) questionnaires will be completed either by phone, mail, or email (depending on participant preference) to assess longer-term effects of eSNAP on outcomes versus controls.
Control - Primary Brain Tumor; Questionnaires Only Control: Family caregivers of primary brain tumor patients.	Behavioral: Questionnaires; Participants will complete demographics and baseline (T1; baseline) questionnaires. For all participants Time 2 (T2; 3 week) and Time 3 (T3; 6 week) questionnaires will be completed either by phone, mail, or email (depending on participant preference) to assess longer-term effects of eSNAP on outcomes versus controls.
Control - Secondary Brain Tumor; Questionnaires Only Control: Family caregivers of secondary brain tumor patients.	Behavioral: Questionnaires; Participants will complete demographics and baseline (T1; baseline) questionnaires. For all participants Time 2 (T2; 3 week) and Time 3 (T3; 6 week) questionnaires will be completed either by phone, mail, or email (depending on participant preference) to assess longer-term effects of eSNAP on outcomes versus controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire Participation Among Participant Groups	Feasibility 1: Recruitment rates per group.	6 weeks per participant
Retention of Participants Among Participant Groups	Feasibility 2: Retention rates per group.	6 weeks per participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress and Coping - Quality of Life Among Participant Groups	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.	6 weeks per participant
Perceived Social Support - Quality of Life Among Participant Groups	Chi square and generalized linear model (GLM) will be used to analyze utilization of support services differences.	6 weeks per participant
Incidence of Clinic Disruption	Incidence of clinic disruption per participant group.	6 weeks per participant
Incidence of Problems with eSNAP implementation	Chi square and generalized linear model (GLM) will be used to analyze trends in satisfaction or time spent on ecomapping/eSNAP.	6 weeks per participant

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH); University of Utah
• Investigators: Principal Investigator: Maija Reblin, Ph.D., H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

General Publications

• 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.

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 5, 2017
• Primary Completion (ACTUAL): October 17, 2017
• Study Completion (ACTUAL): October 17, 2017

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (ESTIMATE): January 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Feasibility; Stress; Quality of life; Brain; Caregivers; Family caregivers; Social support; Nervous system; Brain tumors; Neuro-oncology; Cancer patient; Electronic Social Network Assessment Program (eSNAP)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: MCC-18378; R03CA201684-01 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No