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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA236034-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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The purpose of the study is to determine if family caregivers of neuro-oncology patients feel less burdened by utilizing the Electronic Social Network Assessment Program (eSNAP) + the Caregiver Navigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eSNAP & Caregiver Navigator | Experimental | eSNAP intervention plus questionnaires |
|
| Waitlist Control Condition | No Intervention | Participants randomly assigned to the waitlist control condition will only complete questionnaires during the 8-week study period. After the 8 weeks, they will then have access to the eSNAP, including completion of questionnaires and 8 weeks of Caregiver Navigator sessions as needed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eSNAP | Behavioral | eSNAP is a web based tool that quickly collects and organizes social support information entered by Family Caregivers (FCGs) into visualizations of the size, quality, and function of support networks. Visualizations can help FCGs catalogue support resources and present them in a new way, which may make them more salient and remind FCGs of their availability. |
| Measure | Description | Time Frame |
|---|---|---|
| Family Caregiver Well-Being Using GAD-7 Scale | 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. | 8 weeks per participant |
| Family Caregiver Well-Being Using PHQ-8 Scale | 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. | 8 weeks per participant |
| Family Caregiver Well-Being Using Zarit Burden Interview | 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. | 8 weeks per participant |
| Neuro Patients Well-Being Using GAD-7 Scale | 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. | 8 weeks per participant |
| Neuro Patients Well-Being Using PHQ-8 Scale | 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. | 8 weeks per participant |
| Neuro Patients Well-Being Using NeuroQol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Byrne, PhD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41198147 | Derived | Reblin M, Wells KJ, Zebrack BJ, Witte D, Byrne MM. Associations of Critical Relationships With Distress and Burden in Caregivers of Patients With Brain Tumor. Psychooncology. 2025 Nov;34(11):e70332. doi: 10.1002/pon.70332. | |
| 33865382 | Derived | Reblin M, Ketcher D, McCormick R, Barrios-Monroy V, Sutton SK, Zebrack B, Wells KJ, Sahebjam S, Forsyth P, Byrne MM. A randomized wait-list controlled trial of a social support intervention for caregivers of patients with primary malignant brain tumor. BMC Health Serv Res. 2021 Apr 17;21(1):360. doi: 10.1186/s12913-021-06372-w. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Family Caregivers | Family caregivers (FCGs) of patients with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Family Caregivers | Family caregivers (FCGs) of patients with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only partial healthy care giver demographic data is available for baseline measures since they do not have a medical record |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Family Caregiver Well-Being Using GAD-7 Scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks per participant |
|
|
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Death, serious adverse events, and other (non-serious adverse events) were not assessed for the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Family Caregivers | Family caregivers (FCGs) of patients with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Byrne, Ph.D. | Moffitt Cancer Center | 813-745-5569 | Margaret.Byrne@moffitt.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2024 | May 12, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
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| Caregiver Navigator | Behavioral | The Caregiver Navigator will have social work training and will help Family Caregivers (FCGs) identify and leverage informal and formal social support, including enrolling or directing FCGs to services. |
|
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. |
| 8 weeks per participant |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
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| Sex: Female, Male | Only partial healthy care giver demographic data is available for baseline measures since they do not have a medical record | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| Primary | Family Caregiver Well-Being Using PHQ-8 Scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks per participant |
|
|
|
| Primary | Family Caregiver Well-Being Using Zarit Burden Interview | 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks per participant |
|
|
|
| Primary | Neuro Patients Well-Being Using GAD-7 Scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks per participant |
|
|
|
| Primary | Neuro Patients Well-Being Using PHQ-8 Scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks per participant |
|
|
|
| Primary | Neuro Patients Well-Being Using NeuroQol | 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. | Posted | Mean | Standard Error | T-Score | 8 weeks per participant |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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