Supportive Care Intervention Development to Address Employment Concerns After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Intervention completion Rate
研究概览
简要总结
This is a feasibility study of a Work Support (WorkS) intervention designed to ameliorate employment challenges for people preparing to return to work after allogeneic stem cell transplantation. The aim of this study is to evaluate "proof of concept" by:
- examining the feasibility and acceptability of the WorkS intervention and the study procedures, and
- exploring the preliminary effects of WorkS for improving patient-reported return-to-work self-efficacy, work status, quality of life, and financial toxicity.
详细描述
Participants will be recruited from MGH Cancer Center. The intervention will be delivered at MGH Institute of Health Professions (IHP) and investigators at MGH IHP will be involved in recruiting participants and collecting/managing data.
Participants will be enrolled in the study for approximately six months following the schedule below:
- Enrollment into study: HSCT recipients will be recruited into the study approximately six months post HSCT (+/- one month).
- Baseline assessment: To be completed within 3 weeks of completing informed consent.
- WorkS Appointment #1 and #2: To be completed within a 2-month period after completing the baseline assessment. Ideally, the appointments will be approximately one month apart, but can be timed whenever in the 2-month window that is preferred by the participant.
- Exit assessment: To be completed within 3 weeks of completing Appointment 2.
- Final assessment: Return to work status at 12 months post HSCT (+/- three weeks)
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received an allogeneic HSCT within the past six months to treat a hematological malignancy.
- •Screen positive for work-related concerns (i.e., responds "yes" to the question, "Are you concerned about your ability to return to work in the coming six months?")
排除标准
- •Patients with acute psychiatric or cognitive conditions which the treating clinician believes prohibits informed consent or compliance with the study procedures
- •We will not enroll the following special populations: adults unable to consent, individuals not yet adults, pregnant women, and prisoners.
结局指标
主要结局
Intervention completion Rate
时间窗: Up to 2 months
Number of participants who attended the WorkS sessions / Number enrolled; Feasible if at least 80% of participants complete two sessions.
Eligibility Rate
时间窗: At screening
Number of patients screening positive \& eligible / Number screened
Screening Rate
时间窗: At screening
Number of patients screened / Number undergoing HSCT during study period
Assessment Completion Rate
时间窗: Up to 6 months
Number participants completing each of the three study assessments/ Number of participants enrolled
Enrollment Rate
时间窗: Up to 2 months
Number of participants who attended the WorkS sessions / Number enrolled; Enrollment rate of at least 50% will indicate feasibility.
次要结局
- Financial Toxicity(2 months)
- Quality of Life: Functional Assessment of Cancer Therapy - Bone Marrow Transplant(2 months)
- Return to Work Self-Efficacy(2 months)
- Concerns Regarding Work(2 months)
- Utility of Intervention(2 months)
- Working Status(6 months)
研究者
Kathleen Lyons, ScD, OTR/L
Professor, Occupational Therapy
MGH Institute of Health Professions