Feasibility and Acceptability of A RN-Led Palliative and Supportive Care Intervention for Adults With Acute Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1.
研究概览
简要总结
This single institution feasibility and acceptability study includes patients with acute leukemia which is designed to examine a novel palliative and supportive care intervention (Palliative and supportive Care inTervention; PACT) in which registered nurses (RNs), occupational therapists (OTs), and physical therapists (PTs) address the activity needs of older adults with acute leukemia during their hospital stay.
详细描述
The primary objective of the study is to assess feasibility, acceptability, and change in pre and post measures of symptoms, function, and QOL by administering the PACT intervention. The first 20 participants in the control group will receive usual care. The next 20 participants will receive the PACT intervention. Each participant in the intervention group will be cared by a collaborative, multidisciplinary, integrated team including RNs, OTs and PTs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •≧60 years of age
- •Diagnosis of acute myeloid leukemia
- •Receive low-dose cytarabine or hypomethylating agent (HMA) in combination with Venetoclax chemotherapy
- •Speak and read English
- •Preference will be given to patients with care partners
排除标准
- •Patients receiving hospice care
- •[Caregiver]
- •Inclusion Criteria:
- •≧18 years of age
- •Identified by patient as caregiver
- •Speak and read English
结局指标
主要结局
Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 1.
时间窗: Baseline, up to 30 days
Mean Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in control and intervention arms at Cycle 1. The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and a global health and quality-of-life scale. Most questions used a 4-point scale (1 =Not at all to 4 =Very much); 2 questions used a 7-point scale (1 =Very poor to 7 =Excellent). A higher score=better level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale.
Feasibility and Acceptability
时间窗: Baseline
Feasibility and acceptability will be assessed as the number of participants who were approached, consented to, and eligible for the study.
Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores Between Cycle 1 and Cycle 2.
时间窗: Baseline and until day 30 (Cycle 1 and Cycle 2)
Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in the intervention arm both at Cycle 1 and 2. Score difference for each subject and mean differences between scores were calculated. The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales. Most questions used a 4-point scale (1 =Not at all to 4 =Very much); 2 questions used a 7-point scale (1 =Very poor to 7 =Excellent). A higher score=better level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale.
Comparison of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score in Cycle 2.
时间窗: 30 days after starting to the study
Mean Overall, Physical, Emotional, and Fatigue Quality of Life (QOL) scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in control and intervention arms at Cycle 2. The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties); and a global health and quality-of-life scale. Most questions used a 4-point scale (1 =Not at all to 4 =Very much); 2 questions used a 7-point scale (1 =Very poor to 7 =Excellent). A higher score=better level of functioning or greater degree of symptoms. The scores of these scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale.
Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
时间窗: Up to180 days
19 items include diarrhea, chills, heartburn, nausea, appetite, mouth sores, vomiting, constipation, cough, rash, shortness of breath, fatigue, anxiety, sadness, nothing will cheer me up, pain, insomnia, concentration, and memory. The severity is assessed from "None" to "Very severe" and the interference level is assessed from "Not at all" to "Very much."
Retention Rate
时间窗: Baseline and up to 30 days (first and second cycles)
The rate of participants who consented to the study completed study intervention at the time point.
Symptom Monitoring Data Collection Rate
时间窗: Baseline and up to 30 days (first and second cycles)
The number of participants who joined the study and symptom monitoring were assessed at the time point.
Caregiver Follow-Up Data Collection Rate
时间窗: At second cycle (at days 30)
Caregiver Follow-Up data collection rate was assessed the number of caregiver participants who joined the study and symptom monitoring was assessed at the time points.
次要结局
未报告次要终点