SHARE - Supportive Care Management for Patients With Hematologic Cancers by Registered Nurses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Successful enrollment of 30 patient-caregiver pairs
研究概览
简要总结
This study seeks to develop and pilot-test an oncology nurse-led care management intervention to meet the primary palliative care needs of patients with advanced hematologic malignancies.
详细描述
Study investigators will develop and pilot-test an oncology nurse-led care management intervention to meet the primary palliative care needs of patients with advanced hematologic malignancies.
Aim 1 is a case series to develop and refine the intervention. During this time, we will develop initial interventionist training materials, study protocols, and a web-based outcomes database; train 2 hematology-oncology nurses; enroll 10 patients with advanced hematologic malignancies and their informal caregivers to receive intervention visits; conduct debriefing interviews; iteratively refine the intervention based on nurse, oncologist, patient, and caregiver feedback; and prepare the protocol for Aim 2. Aim 2 is a pilot study to assess the feasibility and acceptability of administering the intervention and assessing outcomes. We will recruit 30 patients and their informal caregivers to receive the intervention developed in Aim 1 and collect measures of quality of life, symptom burden, anxiety and depressive symptoms, caregiver burden, and healthcare utilization at baseline and monthly for up to three months. Trial outcomes will include: rates of enrollment, study completion, and outcome completion; intervention fidelity; and self-reported measures of study burdensomeness and effectiveness among patients, caregivers, and clinicians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults (≥ 21 years old)
- •Refractory or Recurrent hematologic cancer: lymphoma, leukemia, myeloma, amyloidosis (secondary manifestation myeloma & AL Amyloidosis), and CML (CML can only be accelerated or blast phase)
- •planning to receive ongoing care from a participating oncologist and willing to be seen at least monthly.
- •Exclusion criteria:
- •chronic myeloid leukemia (CML) OTHER THAN accelerated or blast phase
- •unable to read and respond to questions in English
- •lacks decision-making capacity, as determined by the patient's oncologist
- •unable to complete baseline interview
- •Inclusion Criteria:
- •adults (≥ 21 years old)
- •family member or friend of an eligible patient
- •Exclusion criteria:
- •unable to read and respond to questions in English
- •unable to complete the baseline interview (patients will be asked to select as caregiver the person who is most likely to accompany them to visits or help with their care should they need it)
- •Eligible clinicians will be oncology nurses and oncologists practicing at participating clinics.
排除标准
- 未提供
结局指标
主要结局
Successful enrollment of 30 patient-caregiver pairs
时间窗: Baseline to 3 months
次要结局
- Outcome assessment rate(Baseline to 3 months)
- Missing data(Baseline to 3 months)
- Acceptability(3 months)
- Intervention fidelity(Baseline to 3 months)
- Consent-to-approach rate(Baseline to 3 months)
- Enrolled-to-consent rate(Baseline to 3 months)
- Intervention completion rate(Baseline to 3 months)
研究者
Yael Schenker, MD, MAS
Assistant Professor Director, Palliative Care Research
University of Pittsburgh