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| ID | Type | Description | Link |
|---|---|---|---|
| R03CA201684-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| University of Utah | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - Primary Brain Tumor | eSNAP Intervention Plus Questionnaires: Family caregivers of primary brain tumor patients. |
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| Intervention - Secondary Brain Tumor | eSNAP Intervention Plus Questionnaires: Family caregivers of secondary brain tumor patients. |
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| Control - Primary Brain Tumor | Questionnaires Only Control: Family caregivers of primary brain tumor patients. |
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| Control - Secondary Brain Tumor | Questionnaires Only Control: Family caregivers of secondary brain tumor patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eSNAP | Behavioral | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be family caregivers recruited from the Moffitt Cancer Center Radiation Oncology Clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Maija Reblin, Ph.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29948397 | Derived | 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. |
| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Questionnaires | Behavioral | 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. |
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| 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 |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |