Clinical Trial Investigating Pedometer-based Activity Monitoring After Autologous Transplantation in Lymphoma and Myeloma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Professional Activity
研究概览
简要总结
The trial assess the proportion of patients who resumed their professional activity within 100 days after ASCT (autologous stem cell Transplantation).
详细描述
Patient-reported outcome measures (PROMs) Cancer patients experience significant physical and psychosocial consequences of cancer and treatment which affect quality of life (QoL). These consequences may be under-recognized and under-treated in oncology practice, resulting in greater morbidity that is costly to patients and the health system. Patient-reported outcome measures (PROMs) are advocated for use in routine cancer clinical practice for early detection of distress and as a performance metric for evaluating the quality of care on health outcomes.
A PROM is defined as 'any report coming directly from the patient about a health condition and its treatment using a self-reported measure. PROMs focus on physical symptoms, treatment toxicities, psychosocial problems or global health-related quality of life (HRQoL) impacts of a health condition. PROMs that capture the whole-person impact of cancer and treatments on health outcomes are increasingly recommended by patients, clinicians, and decision makers.
A number of implementation issues related to the use of PROMs data need to be considered: (i) limiting data collection so as to minimize patient burden and completion time, (ii) collecting PROM data at baseline and selected follow-up times while minimizing the number of assessments, (iii) considering whether measurement equivalence has been established when using different modes of patient-reported data collection (e.g. web, telephone, tablet, or paper), (iv) collecting data via electronic technologies whenever possible, and (v) employing methods to minimize missing data including educating site personnel, patients and clinicians, and real-time monitoring of adherence.
Step counting devices to monitor physical activity The intensive medical treatment of patients with hematologic malignancies is associated with numerous long-term adverse effects, including anemia, fatigue, and reduced physical exercise capacity. Patients with hematologic malignancies may benefit from physical exercise programs in terms of maintenance or even improvement in fatigue, physical activity, and fitness levels. Since many patients with hematologic malignancies are young and professionally active, regaining physical activity is a prerequisite for timely resuming professional activities, and, thus, of immediate socio-economic relevance. A major component of daily physical activity and the most common form of exercise is walking. Walking is self-regulated in intensity, duration, and frequency, and it can be an important indicator of a person's health and fitness status. The improvement of functional status is a primary goal in the rehabilitation of cancer patients. It is thus crucial to be able to document quantitatively the walking activity of patients who are recovering from intensive medical treatment. An understanding of the quantity (or lack) of walking activity seems particularly important in addressing the needs of cancer patients who are recovering from intensive medical treatment
Patients with hematologic malignancies recovering from intensive medical treatment such as after high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) can benefit from gradually regaining a more physically active lifestyle, typically by increasing ambulatory activity. Step counting devices (accelerometers and pedometers) offer an opportunity to monitor daily ambulatory activity. Tudor-Locke and Bassett originally proposed a graduated step index to describe pedometer-determined habitual physical activity in adults:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with plasma cell disorders (myeloma and amyloidosis) or with lymphomas (NHL and Hodgkin) undergoing high-dose chemotherapy with autologous stem cell transplantation.
- •Patients must be aged 18-65 years.
- •Patients must have given voluntary written informed consent.
- •Patients without professional activity (such as due to early retirement, dependency on disability reimbursement, or unemployment) are eligible.
排除标准
- •Patients with other serious medical condition that could potentially interfere with the completion of treatment according to this protocol.
- •Lack of patient cooperation to allow study treatment as outlined in this protocol.
结局指标
主要结局
Professional Activity
时间窗: 100 days
Number of patients who resumed their professional activity within 100 days after ASCT.
次要结局
- Physical activity(100 days)
- Febrile Episodes(100 days)
- Well-being(100 days)
