Phase II Study of Digital Life Coaching in Multiple Myeloma Patients Undergoing Stem Cell Transplantation
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
- Comparison of patients with >=1 benzodiazepine and Z-class (B/Z) prescriptions (versus < 1 B/Z prescriptions)
研究概览
简要总结
Autologous stem cell transplantation (SCT) is the standard of care for fit multiple myeloma (MM) patients; however, the first 100 days after SCT are marked by extensive life disruptions. We have found a 56% relative increase in the use of high-risk benzodiazepine and Z-class (B/Z) drugs for anxiety and insomnia among MM patients during this period. Digital life coaching (DLC), whereby trained coaches work longitudinally with patients through phone calls and text messages to accomplish personal goals, may be able to target anxiety and insomnia in a more integrative manner. This study will investigate whether peri-SCT DLC can lower B/Z usage and improve patient-reported well-being.
详细描述
This is a single-center, Phase II randomized study of MM patients comparing 16 weeks of DLC access versus quasi-usual care (quasi-usual because both arms will receive generic wellness-related electronic handouts alongside requests for patient-reported outcome (PRO) assessments).
Primary Objective:
To evaluate DLC's impact on B/Z drug usage (excluding lorazepam prescribed for chemotherapy-induced nausea/vomiting, or CINV)
Secondary Objectives:
- To evaluate DLC's impact on patient-reported general quality of life every 1-2 weeks
- To evaluate DLC's impact on patient-reported psychosocial distress every 1-2 weeks
- To evaluate DLC's impact on patient-reported insomnia every 1-2 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 multiple myeloma (MM) for the purposes of this protocol):
- •Multiple myeloma (ICD-10 code: C90.0)
- •Extramedullary plasmacytoma (ICD-10 code: C90.2)
- •Planned receipt of autologous stem cell transplantation (SCT) at University of California, San Francisco (UCSF)
- •Patients undergoing outpatient SCT will be eligible
- •Patients who received chemomobilization will be eligible
- •Ability to understand a written informed consent form (ICF) document, and the willingness to sign the ICF document
排除标准
- •Age < 18 years
- •SCT as salvage therapy
- •Patient-assessed lack of sufficient English proficiency
- •Lack of ownership of a personal smartphone
结局指标
主要结局
Comparison of patients with >=1 benzodiazepine and Z-class (B/Z) prescriptions (versus < 1 B/Z prescriptions)
时间窗: Up to 6 months
Proportions of patients with \>=1 B/Z prescription versus \<1 B/Z prescriptions will be compared between arms using chi-square analyses. Participants will be stratified on B/Z usage over time into 3 groups arms based on B/Z-naïve status (i.e., no B/Z usage at time of study enrollment), baseline psychosocial distress, defined as an National Comprehensive Caner Network (NCCN) Distress Thermometer (DT) score of 4 or higher, and baseline insomnia, defined as a Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance short form (SF) 4 item (4a) standardized score of 57 or higher.
Estimate change in B/Z usage
时间窗: Up to 6 months
Estimations or differences in changes over time by study group will be performed via a post-estimation test using one-sided t-tests at each assessment. To control the family wise error rate at alpha level of 0.05, the Bonferroni method will be used.
Number of participants with a missing NCCN Distress Thermometer (DT) assessment
时间窗: Up to 6 months
Sensitivity analyses for missing data will be performed on participants with missing NCCN DT Assessments
Number of participants with a missing PROMIS Sleep Disturbance SF-4a inventory
时间窗: Up to 6 months
Sensitivity analyses for missing data will be performed on participants with missing PROMIS Sleep Disturbance SF-4a inventories.
Number of participants with a missing Patient Reported Outcome Measurement Information System (PROMIS) Global Health (GH) assessment
时间窗: Up to 6 months
Sensitivity analyses for missing data will be performed on participants with missing PROMIS Global Health assessments
次要结局
- Change in NCCN Distress Thermometer (DT) Scores(Up to 6 months)
- Change in PROMIS 4-item Sleep Disturbance Short Form (SF-4a) Scores(Up to 6 months)
- Change in PROMIS Global Health (GH) Scale Scores(Up to 6 months)