Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator Intervention for Neuro-Oncology
概览
- 阶段
- 不适用
- 干预措施
- eSNAP
- 疾病 / 适应症
- Brain Cancer
- 发起方
- H. Lee Moffitt Cancer Center and Research Institute
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- Family Caregiver Well-Being Using GAD-7 Scale
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
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.
研究者
入排标准
入选标准
- •English-speaking/reading/writing
- •Able to complete questionnaires (including by proxy)
- •Family Caregivers (FCGs) must self-identify as being a primary FCG of a patient with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease diagnosis. A primary caregiver is a family member, friend, or other unpaid person who provides at least some care for a patient at home.
- •Patients must be diagnosed with new or recurrent primary brain tumor, a secondary (metastatic) brain tumor or leptomeningeal disease within the last 9 months, receiving at least some evaluation and/or care at Moffitt (i.e. at least one appointment), have a prognosis of at least 9 months
排除标准
- •Patients may not participate without a consenting FCG, but FCGs may participate without a consenting patient
- •Patients and FCGs who are experiencing acute distress will be excluded from enrollment and referred directly to social work, per Moffitt policy.
研究组 & 干预措施
eSNAP & Caregiver Navigator
eSNAP intervention plus questionnaires
干预措施: eSNAP
eSNAP & Caregiver Navigator
eSNAP intervention plus questionnaires
干预措施: Caregiver Navigator
Waitlist Control Condition
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.
结局指标
主要结局
Family Caregiver Well-Being Using GAD-7 Scale
时间窗: 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.
Family Caregiver Well-Being Using PHQ-8 Scale
时间窗: 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.
Neuro Patients Well-Being Using GAD-7 Scale
时间窗: 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.
Family Caregiver Well-Being Using Zarit Burden Interview
时间窗: 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.
Neuro Patients Well-Being Using PHQ-8 Scale
时间窗: 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.
Neuro Patients Well-Being Using NeuroQol
时间窗: 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.