A Pilot Study Evaluating Feasibility, Acceptability, Usability, Satisfaction and Preliminary Efficacy of an Intervention for Caregivers of Patients Undergoing HSCT or CAR T-cell Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Average System Usability Scale scores
研究概览
简要总结
The purpose of this study is to determine which of two approaches is helpful to support caregivers of patients undergoing Hematopoietic Stem Cell Transplant (HSCT) or Chimeric Antigen Receptors (CAR) T-cell therapy at Seidman Cancer Center. This study will take start before you begin treatment until 2 months after your hospital discharge.
详细描述
This is a two-group, randomized pilot study to test the feasibility, acceptability, usability, satisfaction and preliminary efficacy of a behavioral (psychoeducation) intervention, as compared to a usual care (information from healthcare providers) control group, on caregiver outcomes. The control and intervention groups will receive the standard University Hospitals Seidman Cancer Center (SCC) binder of relevant information regarding care of the patient undergoing HSCT or CAR T-cell therapy. This information will be given to the caregiver by the health care provider. In addition, the intervention group will receive 6 individual sessions with an interventionist during all phases of HSCT or CAR T-cell therapy. The independent variable is group assignment.
The primary objective of this study is to explore the feasibility and acceptability of a psycho-educational intervention designed for caregivers of patients receiving HSCT (allogenic or autologous) or CAR T-cell therapy.
The secondary objective of this study is to explore the usability, satisfaction and preliminary efficacy of a psycho-educational intervention designed for caregivers of patients receiving HSCT (allogenic or autologous) or CAR T-cell therapy.
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
- •Patients:
- •Has a diagnosis of blood cancer (leukemia, lymphoma, myeloma, MDS, MPN, CML, CMML) and is scheduled to undergo HCST or CAR T-cell therapy at SCC
- •Will receive HSCT or CAR T-cell therapy and follow-up care from a medical oncologist at University Hospitals Seidman Cancer Center (SCC)
- •Has English as their primary language
- •Provides consent for his/her own treatment and procedures
- •Has an identified caregiver (per SCC-HSCT and CAR T-cell therapy protocol) who will be involved in the patient's care post-HCST or CAR T-cell therapy
- •Caregivers
- •An adult family or friend (at least 18 years old) of a patient scheduled to receive HSCT or CAR T-cell therapy at SCC
- •Identifies himself/herself as the caregiver who will be responsible for the patient's care post-HSCT or CAR T-cell therapy
- •Has English as their primary language
- •Is capable of providing informed consent
排除标准
- 未提供
结局指标
主要结局
Average System Usability Scale scores
时间窗: 2 months post-hospital discharge, an average of 2 months
Usability, as measured by average System Usability Scale scores. This is a 10 item scale scored on a 5 point Likert scale with total summed scores ranging from 0-50. Total scores are multiplied by 2 to produce an overall score ranging from 0-100 with scores \> 68 considered to be above average usability.
Mean caregiver satisfaction
时间窗: 2 months post-hospital discharge, an average of 2 months
Caregiver satisfaction will be evaluated by having caregivers evaluate their satisfaction with each of the 6 modules at the end of each module. After completing each module, they will be sent via REDCap a single item evaluation scale (0 -10; 0=Not at all satisfied; 10=Highly satisfied). Scores \>7 will be considered acceptable. Mean and standard deviation to describe subjects' overall satisfaction with the intervention reported.
End-of-study caregiver satisfaction scores
时间窗: 2 months post-hospital discharge, an average of 2 months
End-of-study caregiver satisfaction, as measured by end of study exit interview that assesses overall satisfaction with intervention (Likert Scale). Scores range from 0 to 10, with higher scores indicating more satisfaction.
Data collection completion rate
时间窗: 2 months post-hospital discharge, an average of 2 months
Feasibility as measured by completion of data collection across study timepoints
Time to identify and recruit dyads in months
时间窗: 2 months post-hospital discharge, an average of 2 months
Feasibility, as measured by time to identify and recruit dyads (benchmark 3 months)
Accrual rates
时间窗: 2 months post-hospital discharge, an average of 2 months
Feasibility, as measured by accrual rates of eligible participants
Retention rate
时间窗: 2 months post-hospital discharge, an average of 2 months
Feasibility, as measured by retention rate
Average acceptability scale scores
时间窗: 2 months post-hospital discharge, an average of 2 months
Acceptability, as measured by average acceptability scale scores, with overall score ranging from 6-30. According to prior research, a score of 80% of higher (total score of 24 or higher) is considered acceptable for use.
次要结局
- Distress as measured by the the NCCN distress thermometer(Baseline, hospital discharge, 2 months post hospital discharge)
- Caregiver anxiety as measured by PROMISR Short Form v1.0 - Anxiety scores(Baseline, hospital discharge, 2 months post hospital discharge)
- Caregiver Healthcare Related Quality Of Life (HRQOL)(Baseline, hospital discharge, 2 months post hospital discharge)