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

Brain Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026699
• Other study ID #: MCC-18378
• Secondary ID: R03CA201684-01
• Status: Completed
• Start date: May 5, 2017
• Est. completion date: October 17, 2017

Study information

• Verified date: December 2020
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 17, 2017
• Est. primary completion date: October 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (4)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI), National Institutes of Health (NIH), University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire Participation Among Participant Groups	Feasibility 1: Recruitment rates per group.	6 weeks per participant
Primary	Retention of Participants Among Participant Groups	Feasibility 2: Retention rates per group.	6 weeks per participant
Secondary	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
Secondary	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
Secondary	Incidence of Clinic Disruption	Incidence of clinic disruption per participant group.	6 weeks per participant
Secondary	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

External Links

•   Moffitt Cancer Center Clinical Trials website