Pilot Study to Develop a Transplant Wellness Clinic for Elderly or High Risk Patients Undergoing Blood and Marrow Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Length of transplant stay in days
研究概览
简要总结
As the average age of individuals undergoing stem cell transplant continues to increase, challenges associated with balancing the side effects of cancer treatments while also managing other medical conditions develop. Studies have shown these individuals develop more treatment related side effects and take longer to leave the hospital due to complications. The purpose of this study is to develop a multiple provider clinic that will help identify any additional needs in the more complicated and generally older transplant patient population. If needed, this clinic will recommend interventions or referrals to the appropriate specialties to the participant and the transplant physician for the participant before your transplant procedure. Examples of potential areas of improvement include a course of physical therapy, nutritional supplements, or modifications of medications, among others with the goal to make your transplant safer and to decrease length of time in the hospital.
详细描述
This is a supportive interventional study to assess frailty in at risk geriatric cancer patients undergoing stem cell transplant and to determine if specific interventions are feasible and will improve overall outcomes.
A total of 20 participants will be enrolled in this study with the first 10 participants limited to myeloma or lymphoma patients who meet eligibility criteria and are candidates for autologous transplantation. The second 10 participants enrolled will be either allogeneic or autologous stem cell transplant candidates who meet eligibility criteria.
The objectives of this study are as follows:
- To pilot a comprehensive multidisciplinary geriatric assessment clinic.
- To determine whether a comprehensive geriatric assessment (outside of physical therapy assessment) can be performed in a time efficient manner. The goal is to complete all questionnaires and the multidisciplinary assessments in <90 minutes.
- To assess participant and physician satisfaction
- To determine if interventions recommended in the clinic are achievable for each participant
- Examples of interventions could include, medication changes, management of depression, dietary modifications, physical therapy three times a week, etc.
- To determine if participation in the transplant wellness clinic reduces length of stay and readmission rate compared to historical controls at our institution
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Deemed candidate for autologous or allogeneic transplantation by their Stem Cell Transplant Attending Physician
- •Stem cell transplant candidates > 60 years
- •Younger patients with age adjusted HCT- CMI> 4
- •Outpatient at time of enrollment.
- •Must have at a minimum 4 weeks and a maximum of 12 weeks before anticipated start of transplant procedures, ie initiation of preparation regimen or beginning of peripheral stem cell mobilization
- •Must have transportation to outpatient appointments
- •Must be able to read and understand English to complete the required questionnaires Must be able to read and understand protocol consent
排除标准
- •Those who are not felt to be candidates for autologous or allogeneic stem cell transplantation
结局指标
主要结局
Length of transplant stay in days
时间窗: Assessed up to 6 months after transplant
Length of transplant stay will be collected for all participants and compared to historical controls of similar age
Time to complete geriatric assessment clinic
时间窗: at time of assessment (an average of 90 minutes)
Time to complete geriatric assessment clinic will be collected. Feasibility will be defined if 7 or more of the first 10 patients are able to complete the geriatric assessment clinic in under 90 minutes.
Physician satisfaction as determined by "physician questionnaire"
时间窗: at time of assessment (less than 1 hour)
Analysis of patient and physician questionnaires will be tabulated and results reported in a descriptive fashion
Readmission rates
时间窗: Up to 100 days after transplant
Readmission rates in the first 100 days post-transplant will be collected and compared to historical controls using Chi-square test
Patient satisfaction as determined by "patient follow-up quesitonnaire"
时间窗: at time of assessment (less than 1 hour)
Analysis of patient and physician questionnaires will be tabulated and results reported in a descriptive fashion
次要结局
未报告次要终点