Trial Outcomes & Findings for Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator (NCT NCT04268979)

NCT ID: NCT04268979

Last Updated: 2025-11-18

Results Overview

Caregiver well being will be measured using the Generalized Anxiety Disorder 7 Item Scale (GAD-7). The GAD-7 measures anxiety scoring 0-3 points per item, with a total score range 0-21,with a higher score meaning more anxiety.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

296 participants

Primary outcome timeframe

8 weeks per participant

Results posted on

2025-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Family Caregivers Family caregivers (FCGs) of patients with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease.	Neuro Patients Patients diagnosed with a new or recurrent primary brain tumor, a secondary (metastatic) brain tumor, or leptomeningeal disease within the last 9 months, and receiving at least some evaluation and/or care at Moffitt.
Overall Study STARTED	148	148
Overall Study COMPLETED	102	89
Overall Study NOT COMPLETED	46	59

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Only partial healthy care giver demographic data is available for baseline measures since they do not have a medical record

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Family Caregivers n=148 Participants Family caregivers (FCGs) of patients with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease.	Neuro Patients n=148 Participants Patients diagnosed with a new or recurrent primary brain tumor, a secondary (metastatic) brain tumor, or leptomeningeal disease within the last 9 months, and receiving at least some evaluation and/or care at Moffitt.	Total n=296 Participants Total of all reporting groups
Race (NIH/OMB) Black or African American	4 Participants n=148 Participants	6 Participants n=148 Participants	10 Participants n=296 Participants
Age, Continuous	57.1 years n=122 Participants • Only partial healthy care giver demographic data is available for baseline measures since they do not have a medical record	58.2 years n=148 Participants • Only partial healthy care giver demographic data is available for baseline measures since they do not have a medical record	57.7 years n=270 Participants • Only partial healthy care giver demographic data is available for baseline measures since they do not have a medical record
Sex: Female, Male Female	87 Participants n=124 Participants • Only partial healthy care giver demographic data is available for baseline measures since they do not have a medical record	68 Participants n=148 Participants • Only partial healthy care giver demographic data is available for baseline measures since they do not have a medical record	155 Participants n=272 Participants • Only partial healthy care giver demographic data is available for baseline measures since they do not have a medical record
Sex: Female, Male Male	37 Participants n=124 Participants • Only partial healthy care giver demographic data is available for baseline measures since they do not have a medical record	80 Participants n=148 Participants • Only partial healthy care giver demographic data is available for baseline measures since they do not have a medical record	117 Participants n=272 Participants • Only partial healthy care giver demographic data is available for baseline measures since they do not have a medical record
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=148 Participants	0 Participants n=148 Participants	0 Participants n=296 Participants
Race (NIH/OMB) Asian	0 Participants n=148 Participants	2 Participants n=148 Participants	2 Participants n=296 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=148 Participants	0 Participants n=148 Participants	0 Participants n=296 Participants
Race (NIH/OMB) White	113 Participants n=148 Participants	131 Participants n=148 Participants	244 Participants n=296 Participants
Race (NIH/OMB) More than one race	5 Participants n=148 Participants	0 Participants n=148 Participants	5 Participants n=296 Participants
Race (NIH/OMB) Unknown or Not Reported	26 Participants n=148 Participants	9 Participants n=148 Participants	35 Participants n=296 Participants
Region of Enrollment United States	148 participants n=148 Participants	148 participants n=148 Participants	296 participants n=296 Participants

PRIMARY outcome

Timeframe: 8 weeks per participant

Caregiver well being will be measured using the Generalized Anxiety Disorder 7 Item Scale (GAD-7). The GAD-7 measures anxiety scoring 0-3 points per item, with a total score range 0-21,with a higher score meaning more anxiety.

Outcome measures

Outcome measures
Measure	Family Caregivers n=94 Participants Family caregivers (FCGs) of patients with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease.
Family Caregiver Well-Being Using GAD-7 Scale	8.95 score on a scale Standard Deviation 6.08

PRIMARY outcome

Timeframe: 8 weeks per participant

Caregiver well being will be measured using the Personal Health Questionnaire Depression 8 Item Scale Scale (PHQ 8). The PHQ 8 measures depression scoring 0-3 points per item, with a total score range of 0-24, with the higher score meaning more depression.

Outcome measures

Outcome measures
Measure	Family Caregivers n=94 Participants Family caregivers (FCGs) of patients with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease.
Family Caregiver Well-Being Using PHQ-8 Scale	7.11 score on a scale Standard Deviation 5.45

PRIMARY outcome

Timeframe: 8 weeks per participant

Caregiver well being will be measured using the Zarit Burden Interview. The Zarit Burden Interview measures burden scoring 0-4 points per item, with a total score range of 0-48, with the higher score meaning more burden.

Outcome measures

Outcome measures
Measure	Family Caregivers n=94 Participants Family caregivers (FCGs) of patients with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease.
Family Caregiver Well-Being Using Zarit Burden Interview	13.77 score on a scale Standard Deviation 9.15

PRIMARY outcome

Timeframe: 8 weeks per participant

Neuro patients well being will be measured using the Generalized Anxiety Disorder 7 Item Scale (GAD-7). The GAD-7 measures anxiety scoring 0-3 points per item, with a total score range 0-21,with a higher score meaning more anxiety.

Outcome measures

Outcome measures
Measure	Family Caregivers n=56 Participants Family caregivers (FCGs) of patients with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease.
Neuro Patients Well-Being Using GAD-7 Scale	5.66 score on a scale Standard Deviation 5.40

PRIMARY outcome

Timeframe: 8 weeks per participant

Neuro patients well being will be measured using the Personal Health Questionnaire Depression 8 Item Scale Scale (PHQ 8). The PHQ 8 measures depression scoring 0-3 points per item, with a total score range of 0-24, with the higher score meaning more depression.

Outcome measures

Outcome measures
Measure	Family Caregivers n=56 Participants Family caregivers (FCGs) of patients with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease.
Neuro Patients Well-Being Using PHQ-8 Scale	7.91 score on a scale Standard Deviation 5.77

PRIMARY outcome

Timeframe: 8 weeks per participant

Neuro patients well being will be measured using Neuro-Qol (Neuro Quality of Life) which will be using T scores where the lower values represent worse outcomes. 50 indicates the population mean with a standard deviation of 10.

Outcome measures

Outcome measures
Measure	Family Caregivers n=86 Participants Family caregivers (FCGs) of patients with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease.
Neuro Patients Well-Being Using NeuroQol	40.9 T-Score Standard Error 2.6

Adverse Events

Family Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Neuro Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Margaret Byrne, Ph.D.

Moffitt Cancer Center

Phone: 813-745-5569

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place