NCT07591623尚未招募不适用
Identifying And Addressing Distress And Unmet Needs Of Gynecologic Cancer Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
研究概览
简要总结
This study is a prospective longitudinal cohort study with an embedded intervention. It follows participants with gynecologic malignancies and their informal caregivers over a 6-month period to assess caregiver distress, NMDOH, and patient outcomes.
详细描述
Primary Objectives:
Caregivers of patients with gynecologic cancers are at risk for significant distress, which is further impacted by NMDOH. Although caregiver distress affects patient outcomes, it is not routinely measured or addressed in the clinical setting, and little is known about disparities in caregivers' distress and burden in a diverse gynecologic cancer population.
We, therefore, propose the following objectives:
- To measure distress and define the NMDOH needs of caregivers of patients with gynecologic cancers
- To address unmet needs of gynecologic cancer caregivers through a semi-automated system to navigate caregivers to NMDOH and caregiving resources
- To evaluate changes over time in caregivers' unmet needs and distress following receipt of a semi-automated, targeted caregiver resource navigation (CRN) system, and to explore associations between changes in caregiver needs/distress and patients' cancer-related outcomes and distress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study will include participants from two categories:
- •Must be at least 18 years old
- •Must read and speak English or Spanish
- •Participants must have access to the internet via a smartphone, tablet, or computer (public or private), or have reliable access to a telephone to communicate with the study coordinator.
- •Patient presenting for initial or recurrence chemotherapy treatment for management of a gynecologic malignancy (cancer of the ovary, uterus, cervix, vulva, vagina, peritoneum, or fallopian tube)
- •No physical, psychological, or cognitive impairments that would preclude participation and ability to understand the consent statement
- •Caregivers:
- •Must be at least 18 years old
- •Must read and speak English or Spanish
- •Participants must have access to the internet via a smartphone, tablet, or computer (public or private), or have reliable access to a telephone to communicate with the study coordinator.
- •Must be an identified caregiver of an enrolled patient
- •No physical, psychological, or cognitive impairments that would preclude participation and ability to understand the consent statement
- •The study will include patients with no caregiver, and only one caregiver may enroll per patient.
排除标准
- •1. Unwilling or unable to proceed beyond the consent statement step Caregivers
- •1. Unwilling or unable to proceed beyond the consent statement step
研究者
研究点 (1)
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