Intervention Development and Evaluation to Reduce Disparities in Quality of Life for Latino Families Impacted by Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Parental Perceived Stress
研究概览
简要总结
The purpose of this study is to determine if a culturally relevant caregiver intervention is effective in decreasing stress and improving quality of life in Spanish speaking Latino caregivers of children diagnosed with cancer compared to a control group.
详细描述
Phase 1:
Following informed consent, participants will be asked to complete measures at baseline, post intervention(T2), and 3 months post intervention (T3). Once baseline questionnaires are completed, subjects will participate in a 13-week intervention, comprised of live sessions aimed to address the components of, health literacy, caregiver wellness, and culturally competent care. Content of the sessions include culinary medicine, psycho-education, complementary alternative medicine, gardening, dance-based movement, question-answer forums and spirituality.
Participants will have access to a study specific a site which host recordings of all intervention sessions delivered throughout the intervention period and will track frequency and duration of video usage. Additionally, participants will have the opportunity to connect with each other outside of weekly sessions, using the chat feature within the video hosting platform.
All parts of the 13-session intervention will be delivered virtually via Zoom to ensure accessibility. Sessions will be scheduled on the dates and times most convenient for participants to encourage regular caregiver attendance. Zoom links will be shared with participants on a weekly basis via text or email. All sessions will be delivered in Spanish by native Spanish speakers with the exception of week 7 of the intervention. A translator will be present to facilitate this session.
Sessions are intended for caregivers specifically, however, other members of the family may join if they choose to. Sessions may require supplies for participant participation and engagement. In these circumstances the research team will provide supply kits to each participant. Additionally, participants will be loaned tablets as well as mobile hotspots throughout the intervention period to ensure equal opportunity for participation in this virtual pilot intervention. A member of the research team will be present at each session taking notes and assisting with any technical issue that may arise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caregiver of a Children's Hospital of Orange County (CHOC) oncology patient between the ages of 2-17 years old
- •Caregiver of a CHOC oncology patient within 12 months of cancer diagnosis
- •Caregiver of CHOC oncology patient must be able to speak and/or read and write in Spanish.
- •Caregiver identifies as Latino
排除标准
- •Presence of developmental disabilities, cognitive impairment, or severe psychiatric illness that would preclude participation in intervention sessions or interviews among caregivers and patients
- •Caregiver unable to speak, read, and write in Spanish
结局指标
主要结局
Parental Perceived Stress
时间窗: baseline, immediately after the intervention, and 3 months post intervention
Parental stress will be assessed using the Perceived Stress Scale (PSS). The PSS is a widely used 14-item self-report measure of perceived stress. Parents will be asked to rate statements such as "In the past month, how often have you been upset because of something that happened unexpectedly?" and "In the past month how often have you felt that things were going your way?" Subjects rate the items on a 5-point Likert-type scale with higher scores reflecting greater perceived stress. Seven items are reverse-keyed and items are summed to obtain the final score. Scores range from 0 -56 with higher scores indicating higher level of perceived stress. The PSS has been shown to have adequate reliability and validity
Parental emotional functioning (ANXIETY)
时间窗: baseline, immediately after the intervention, and 3 months post intervention
Parental emotional functioning will be measured using the Patient-Reported Outcome Measures (PROMIS) short form 8a (Anxiety). This form assesses 8 items of emotional stress and produces a standardized score ranging from 8-40 with higher raw scores signifying poorer emotional functioning.
Parental emotional functioning (DEPRESSION)
时间窗: baseline, immediately after the intervention, and 3 months post intervention
Parental emotional functioning will be measured using the Patient-Reported Outcome Measures (PROMIS) short form 8a (Depression). This form assesses 8 items of emotional stress and produces a standardized score ranging from 8-40 with higher raw scores signifying poorer emotional functioning.
Parental Quality of Life
时间窗: baseline, immediately after the intervention, and 3 months post intervention
Parental quality of life (Health Survey) will be assessed using the Medical Outcomes Survey (MOS Short Form-36), which is a widely used measure of both physical and mental functioning. scores range from 0-100 with lower scores representing more disability. The higher the score the less disability. Reliability and validity are good.
次要结局
未报告次要终点
研究者
Michelle Fortier
Professor
University of California, Irvine