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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-10004 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (GO!) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Promotion and Education | Other | Undergo GO! |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 6 months before transplant, up to 12 months after transplant |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 6 months before transplant, up to 12 months after transplant |
| Change in in Mini Nutritional Assessment score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Wall, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Medical Device Usage and Evaluation |
| Other |
Wear accelerometer |
|
| Quality-of-Life Assessment | Other | Complete quality of life assessments and diary entries |
|
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| Questionnaire Administration | Other | Complete questionnaires |
|
Wilcoxon signed rank test or McNemar test will be used to assess the change over time in geriatric assessment tools. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At 6 months before transplant, 3, and 6 month after transplant |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D000741 | Anemia, Aplastic |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D019337 | Hematologic Neoplasms |
| D006689 | Hodgkin Disease |
| D009190 | Myelodysplastic Syndromes |
| D055728 | Primary Myelofibrosis |
| D009196 | Myeloproliferative Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D000740 | Anemia |
| D000080983 | Bone Marrow Failure Disorders |
| D001855 | Bone Marrow Diseases |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D006293 | Health Promotion |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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