An interventional study of Health Promotion and Education and Medical Device Usage and Evaluation in Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia and Aplastic Anemia, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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.
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.
III. To evaluate change in cognition and mental health as measured by Montreal Cognitive Assessment, Personal Health Questionnaire-9, Generalized Anxiety Disorder-7, and Transplant Evaluation Rating Scale score before and after GAM intervention.
IV. To determine cumulative incidence rate for receipt of allo-HCT among study participants.
V. To measure overall survival and non-relapse mortality among study participants.
VI. To assess self-reported adherence to prescribed interventions. VII. To measure change in patient-reported quality of life immediately following GAM intervention and up to one year after completion of intervention.
EXPLORATORY OBJECTIVES:
I. To describe patterns of sleep and activity among study participants during intervention period based on accelerometer data.
II. To understand transplant physician rationale for not proceeding to allo-HCT for older patients with eligible diagnoses.
OUTLINE:
Patients undergo personalized Geriatric Optimization (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.
2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Health Promotion and Education · Other: Medical Device Usage and Evaluation · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Undergo GO!
Wear accelerometer
Complete quality of life assessments and diary entries
Also known as: Quality of Life Assessment
Complete questionnaires
Change in 6-Minute Walk Test distance
Wilcoxon signed rank test or McNemar test will be used to assess the change over time in geriatric assessment tools.
Time frame: At 6 months before transplant, up to 12 months after transplant
Change in Short Physical Performance Battery score
Wilcoxon signed rank test or McNemar test will be used to assess the change over time in geriatric assessment tools.
Time frame: At 6 months before transplant, up to 12 months after transplant
Change in in Mini Nutritional Assessment score
Wilcoxon signed rank test or McNemar test will be used to assess the change over time in geriatric assessment tools.
Time frame: At 6 months before transplant, up to 12 months after transplant
Change in cognitive and mental health
Measured by Montreal Cognitive Assessment Generalized Anxiety Disorder-7. Wilcoxon signed rank test or McNemar test will be used to assess the change over time in geriatric assessment tools.
Time frame: At 6 months before transplant, up to 12 months after transplant
Change in cognitive and mental health
Measured by Personal Health Questionnaire-9. Wilcoxon signed rank test or McNemar test will be used to assess the change over time in geriatric assessment tools.
Time frame: At 6 months before transplant, up to 12 months after transplant
Change in cognitive and mental health
Measured by Generalized Anxiety Disorder-7. Wilcoxon signed rank test or McNemar test will be used to assess the change over time in geriatric assessment tools.
Time frame: At 6 months before transplant, up to 12 months after transplant
Change in cognitive and mental health
Measured by Transplant Evaluation Rating scale score. Wilcoxon signed rank test or McNemar test will be used to assess the change over time in geriatric assessment tools.
Time frame: At 6 months before transplant, up to 12 months after transplant
Proportion of sample achieving "normal" scores on geriatric assessment tools
McNemar test will be used to compare proportion of sample achieving normal scores on geriatric assessment tools.
Time frame: At 6 months before transplant, up to 12 months after transplant
Time to receipt of transplant
Estimates of cumulative incidence of receipt of transplant with 95% confidence intervals will be provided for 100 days and one-year after end of treatment.
Time frame: Up to 1 year after treatment
Overall survival
Overall survival will be defined as the period from date of baseline assessment to death from any cause. Date of death will be confirmed by chart review. Will be estimated utilizing Kaplan-Meier method.
Time frame: Up to 12 months after transplant
Non-relapse mortality
Non-relapse mortality will be defined as the period from date of baseline assessment to death without evidence of relapsed primary hematologic disease. Relapse will be treated as competing risk. Documentation of date of relapse will be confirmed by chart review and collaboration with transplant physician if necessary. Estimates of cumulative incidence of non-relapse mortality with 95% confidence intervals will be provided for 100 days and one-year after end of treatment.
Time frame: Up to 12 months after transplant
Adherence to prescribed geriatric optimization plan (GO!) prescription
Will be assessed by self-report through monthly survey during intervention and at end-of-treatment assessment. Participants will be asked to estimate monthly frequency of completing all items in GO! prescription and this information will be collected through REDCap survey. Due to self-report nature of this item, no specific definition of adherence is offered beyond that which is asked of participants.
Time frame: Up to 6 months after transplant
Change in quality of life
Assessed with European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire and Elderly Cancer Patients Module. Wilcoxon signed rank test or McNemar test will be used to assess the change over time.
Time frame: At 6 months before transplant, 3, and 6 month after transplant
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Precursor Cell Lymphoblastic Leukemia-Lymphoma→
Ohio State University Comprehensive Cancer Center