Digital Life Coaching in Multiple Myeloma Patients Undergoing Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Number of participants displaying ongoing engagement with DLC
研究概览
简要总结
This is the first study of digital life coaching (DLC) to engage patients during the peri-HCT period that is punctuated by intensive life changes. DLC may circumvent these limitations by combining the integrative cross-dimensional nature of life coaching with the advantages of mobile health technology. The purpose of this study is to evaluate whether ongoing participant engagement with a DLC platform is feasible for multiple myeloma (MM) patients actively undergoing hematopoietic stem cell transplantation (HCT).
详细描述
Participants will receive unlimited access to Pack Health's DLC platform during a 16-week period encompassing pre-HCT conditioning chemotherapy, post-HCT recovery, and 100-day follow-up. Participants will engage with Pack Health's DLC platform and complete quality of life assessments for 16 weeks beginning from enrollment. At the conclusion of the treatment period, participants will be asked to rate their satisfaction with the DLC platform
Primary Objective:
To evaluate the rate of ongoing participant engagement with a DLC platform during the study period
Secondary Objectives:
- To assess quality of life among participants during the study period
- To assess psychosocial distress among participants during the study period
- To assess sleep disturbances among participants during the study period
- To assess participant satisfaction with the DLC platform at the end of the study period
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of one of the following (all referred to as MM in this protocol):
- •Multiple myeloma (ICD-10 code: C90.0)
- •Extramedullary plasmacytoma (ICD-10 code: C90.2)
- •Planned receipt of autologous HCT at our institution
- •Patients undergoing outpatient HCT will be eligible
- •Patients who received chemomobilization will be eligible
- •Age ≥ 18, as life coaches employed by the DLC vendor are not currently trained to work with pediatric patients
排除标准
- •Prior autologous HCT for any indication
- •Physician-assessed lack of sufficient English proficiency
- •Lack of ownership of a personal smartphone
- •Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with participant's safety, provision of informed consent, or compliance with study procedures
结局指标
主要结局
Number of participants displaying ongoing engagement with DLC
时间窗: Up to 16 weeks
Ongoing participant engagement is defined as at least 4 or more participant-initiated interactions with the DLC platform, including at least 1 interaction in each of four 4-week study sub-periods
次要结局
- Median National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) Score(Up to 16 weeks)
- Median PRO Measurement Information System (PROMIS) Global Health (GH) Score(Up to 16 weeks)
- Median Participant Satisfaction Score(Up to 16 weeks)
- Median PROMIS Sleep Disturbance (SD) Short Form (SF) 4a Score(Up to 16 weeks)