Utilizing a Culturally Tailored Nurse Coaching Intervention to Decrease Symptom Severity and Prevent Dehydration in Patients With Metastatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Incidents of dehydration
研究概览
简要总结
The purpose of the study is to see whether or not a telephone/ text message intervention, delivered by a registered nurse, is helpful in managing symptoms and can also prevent dehydration caused by chemotherapy treatment when given together for patients with metastatic breast, colon, lung or prostate cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for Chemotherapy for the first time (Previous & Ongoing hormonal only treatment allowed OR Neoadjuvant & Adjuvant chemotherapy regimens with 2+ drugs allowed)
- •> 18 years old
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •There are no life expectancy restrictions
- •Women of child-bearing potential are allowed in the study as long as they are eligible for the chemotherapy treatment.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients on immunotherapy only will be excluded
- •Previous chemotherapy
- •Under 18 years old
- •Medically Diagnosed with a Cognitive Impairment. Rationale for excluding people with cognitive impairment is that they would not be able to fully participate in the self-management care aspects of the intervention via the telephone, nor provide informed consent.
- •No access to a telephone
- •Blind or Deaf; If subject is Hearing-impaired or illiterate, then the subject may have a family member participate as a telecommunication surrogate with them in the study
结局指标
主要结局
Incidents of dehydration
时间窗: up to 12 weeks
Incidents of unscheduled medical visits for IV hydration
Change in MDASI scores
时间窗: baseline, up to 12 weeks
MD Anderson Symptom Inventory (MDASI) is a 19 item scale with a score range from 0-10 per symptom question that measures symptom severity plus symptom interference combined to measure total symptom burden. The higher score indicates worsening of symptoms.
次要结局
- change in Partners in Health Scale (PIHS) scores(baseline, up to 12 weeks)
- Change in FACT-C Scores(baseline, up to 12 weeks)
- change in Chronic Disease Self-Efficacy Scale (CDSES) scores(baseline, up to 12 weeks)
- Change in FACT-B Scores(baseline, up to 12 weeks)
- Change in FACT-P Scores(baseline, up to 12 weeks)
- Change in FACT-LC Scores(baseline, up to 12 weeks)
- Percentage of completed call or text message(up to 12 weeks)
研究者
Natasha Solle, PhD, RN
assistant research professor
University of Miami