Sleep and Physical Activity in Patient and Caregiver Dyads Following Allogeneic Hematopoietic Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Quality of Life Questionnaire
研究概览
简要总结
To understand the changes in health-related quality of life of patients and caregivers after allogeneic hematopoietic cell transplantation.
详细描述
Primary Objectives 2.1 Primary Objectives for the Entire Sample (N = 43 Dyads)
- Assess the feasibility and acceptability of obtaining objective sleep and physical activity measures in participants receiving allogeneic HCT and their caregivers during hospitalization (T2), and after discharge (T3) using Fitbits.
- Feasibility will be determined by the percentage of participants and caregivers who wear the Fitbit Inspire 3 for sleep and physical activity data at T2, and T3. For the purposes of this study, if ≥70% of participants and caregivers will wear the Fitbit for 5 of 7 nights for sleep data and at least 10 hours during waking hours for 5 of 7 days for physical activity data at both data collection periods, the study will be determined to be feasible. Feasibility will be reported for participants and caregivers separately and will include the percentage of eligible participants who are approached, agree to participate, and complete research activities.
2.1.1 Primary Objectives for Subgroup (n = 10 Dyads)
• Feasibility for the subgroup of 10 dyads will be determined by the percentage of patients and caregivers who wear the Fitbit for sleep and physical activity data from T3 to T4 (6week period after hospital discharge). For the purposes of this study, if ≥70% of patients and caregivers wear the Fitbit for 29 of 42 nights for sleep data and at least 10 hours during waking hours for 29 of 42 days for physical activity data at T4, the study will be determined to be feasible. Feasibility will be reported for patients and caregivers separately and will include the percentage of eligible participants who are approached, agree to participate, and complete research activities.
Secondary Objectives 2.2 Secondary Objectives for the Entire Sample (N = 43 Dyads)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Eligibility Criteria
- •Participants and caregivers ages 18 years and older.
- •Participants diagnosed with a hematologic malignancy with a scheduled allogeneic HCT.
- •Caregivers identified by participant as the primary caregiver.
- •Participants and caregivers able to read, speak, and consent in English.
- •Participants and caregivers able to understand and be willing to sign a written informed consent document.
- •Participants and caregivers must have internet access via smart phone or tablet with the capacity to 1) download the Fitbit app and 2) complete study assessments with study
排除标准
- •Participant or caregiver unable to provide consent, such as cognitively impaired individuals
- •Participant or caregiver with a diagnosis of sleep apnea.
- •Primary caregiver is a paid professional, such as a live-in Registered Nurse.
- •Participant has multiple caregivers and is unable to identify one primary caregiver.
结局指标
主要结局
Quality of Life Questionnaire
时间窗: Through study completion; an average of 1 year
You will answer questionnaires with a member of the research team. The questionnaires will take about 35 minutes complete. You will be asked questions about your sleep, anxiety and depressive symptoms, fatigue, distress, and your quality of life.
次要结局
未报告次要终点