Optimization of Older Adult Allogeneic Hematopoietic Cell Transplant Candidates to Improve Survival (OTIS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in 6-Minute Walk Test distance
研究概览
简要总结
This clinical trial tests whether a geriatric optimization plan (GO!) works to improve survival in patients over 60 with a hematologic malignancy or bone marrow failure syndrome eligible for allogeneic hematopoietic cell transplant. GO! focuses on creating a tailored and specific plan for each patient to make changes in their daily lives. These may include changes to their diet, sleep, activity, medicines, or even referrals to other providers depending on the patient's needs. Studying survival and quality of life in patients over 60 receiving an allogeneic hematopoietic cell transplant may help identify the effects of treatment.
详细描述
PRIMARY OBJECTIVE:
I. To demonstrate that geriatric assessment with management (GAM) intervention will lead to improved physical functioning in allogeneic hematopoietic cell transplant (allo-HCT)-eligible older adults as measured by improvement in 6-Minute Walk Test distance of at least 35 meters.
SECONDARY OBJECTIVES:
I. To demonstrate that GAM intervention will result in improvement in Short Physical Performance Battery score by at least 1 point or score will remain >= 10 for those with baseline scores >= 10.
II. To demonstrate that GAM intervention will result in improvement in Mini Nutritional Assessment score by at least 2 points or score will remain >= 12 for those with baseline scores >= 12.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 60 years
- •Diagnosed with hematologic malignancy or bone marrow failure syndrome eligible for allogeneic hematopoietic cell transplantation. This includes acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, myeloproliferative neoplasm, myelofibrosis, chronic myeloid leukemia, chronic lymphocytic leukemia, non-Hodgkin lymphoma, Hodgkin lymphoma, multiple myeloma, and aplastic anemia. Disease specific eligibility for allo-HCT to be determined by treating physician
- •Must be able to understand written and spoken English
- •Must be willing to attend all study visits and comply with study procedures for the entire length of the study
排除标准
- •Documented history of dementia
- •No possibility of proceeding to allogeneic hematopoietic cell transplant within the next 6 months as determined by treating physician
- •Scheduled admission for allogeneic hematopoietic cell transplant within 30 days of enrollment
- •Inability or unwillingness to give written informed consent
研究组 & 干预措施
Supportive care (GO!)
Patients undergo personalized GO! plan consisting of study visits over 50 minutes at baseline and 6 months after first visit or at the time of hospital admission for bone marrow transplant and over 25 minutes at 3 and 12 months after transplant. Patients complete questionnaires once a month for up to 6 months and wear an accelerometer for up to 6 months.
干预措施: Health Promotion and Education (Other)
Supportive care (GO!)
Patients undergo personalized GO! plan consisting of study visits over 50 minutes at baseline and 6 months after first visit or at the time of hospital admission for bone marrow transplant and over 25 minutes at 3 and 12 months after transplant. Patients complete questionnaires once a month for up to 6 months and wear an accelerometer for up to 6 months.
干预措施: Medical Device Usage and Evaluation (Other)
Supportive care (GO!)
Patients undergo personalized GO! plan consisting of study visits over 50 minutes at baseline and 6 months after first visit or at the time of hospital admission for bone marrow transplant and over 25 minutes at 3 and 12 months after transplant. Patients complete questionnaires once a month for up to 6 months and wear an accelerometer for up to 6 months.
干预措施: Quality-of-Life Assessment (Other)
Supportive care (GO!)
Patients undergo personalized GO! plan consisting of study visits over 50 minutes at baseline and 6 months after first visit or at the time of hospital admission for bone marrow transplant and over 25 minutes at 3 and 12 months after transplant. Patients complete questionnaires once a month for up to 6 months and wear an accelerometer for up to 6 months.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in 6-Minute Walk Test distance
时间窗: At 6 months before transplant, up to 12 months after transplant
Wilcoxon signed rank test or McNemar test will be used to assess the change over time in geriatric assessment tools.
次要结局
- Change in cognitive and mental health(At 6 months before transplant, up to 12 months after transplant)
- Proportion of sample achieving "normal" scores on geriatric assessment tools(At 6 months before transplant, up to 12 months after transplant)
- Change in Short Physical Performance Battery score(At 6 months before transplant, up to 12 months after transplant)
- Change in in Mini Nutritional Assessment score(At 6 months before transplant, up to 12 months after transplant)
- Time to receipt of transplant(Up to 1 year after treatment)
- Overall survival(Up to 12 months after transplant)
- Adherence to prescribed geriatric optimization plan (GO!) prescription(Up to 6 months after transplant)
- Change in quality of life(At 6 months before transplant, 3, and 6 month after transplant)
- Non-relapse mortality(Up to 12 months after transplant)
研究者
Sarah Wall
Principal Investigator
Ohio State University Comprehensive Cancer Center