Adapting After Discharge From Allogeneic SCT: Partnering Together; Dyadic Intervention to Improve Patient-Family Caregiver Team-Based Management of the Medical Regimen After Allogeneic Hematopoietic Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Health Habits Assessment - modified for stem cell transplant
研究概览
简要总结
Adherence to the medical regimen after stem cell transplant is challenging for both patients and their family caregivers. The investigators propose a randomized clinical trial testing two brief psychosocial interventions to determine if either improves patient and family caregiver psychosocial and health-related outcomes.
详细描述
The investigators propose a randomized controlled trial testing two brief, 4 session psychosocial interventions to help patients and family caregivers better manage the time period after hospital discharge from stem cell transplant. Patients and family caregivers will be randomized to either the skill learning intervention (n=52 patient-family caregiver dyads) or to the supportive care intervention (n=52 patient-family caregiver dyads). The intervention will be conducted via live video conferencing. Patients and family caregivers will complete questionnaires before the intervention and at 1-, 5-, 12-, 24 weeks afterwards. The investigators will determine whether the skills learning group has improved outcomes, including adherence to the medical regimen and perceived task efficacy.
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
- Double (Investigator, Outcomes Assessor)
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
- •Patient scheduled for stem cell transplant at the University of Pittsburgh Hillman Cancer Center
- •18 years or older
- •having a family caregiver age 18 years or older also willing to participate in the study
- •willing to accept randomization
排除标准
- •Prior history of stem cell transplant
- •Non-English speaking
结局指标
主要结局
Health Habits Assessment - modified for stem cell transplant
时间窗: 1-, 5-, 12- and 24-weeks post-intervention
Assess levels of adherence to the post-transplant multi-component medical regimen of 20 main tasks; each task marked as yes = 1/no=0 adherent. Tasks will be grouped and summed into categories including medication taking (3 items, range 0=low to 3 high), infection precautions (6 items; range 0=low to 6 high), catheter/port care (4 items, range 0=low to 4 = high), and lifestyle behaviors (7 items, range 0=low to 7=high). Higher scores indicate greater adherence.
Perceived task efficacy
时间窗: 1-, 5-, 12- and 24-weeks post intervention
Assesses perceptions of efficacy to complete tasks of the post-transplant multi-component medical regimen, 20 items rated on 1=low to 10=high scale, mean score will be used.
次要结局
- Dyadic Adjustment Scale - modified(baseline and 1-, 5-, 12-, 24-weeks post-intervention)
- Caregiver Reaction Assessment(1-, 5-, 12-, 24- weeks)
- PROMIS - 16 v2.1(baseline and 1-, 5-, 12-, and 24-weeks post-intervention)
- Immunosuppressant blood levels(1-, 5-, 12- and 24-weeks post-intervention)
- Patient health care utilization(continuous over 24 weeks post-intervention)
- Patient Health Questionnaire- 9(baseline and 1-,5-,12-, and 24-weeks post-intervention)
- Generalized Anxiety Disorder - 7(baseline and 1-, 5-, 12-, and 24-weeks post-intervention)
- Task Responsibility(1-, 5-, 12-, and 24-weeks post-intervention)
- Cancer and Treatment Distress Scale(baseline and 1-, 5-, 12-, 24-weeks post-intervention)
研究者
Donna Posluszny
Associate Professor
University of Pittsburgh