Geriatric Optimization Plan to Improve Survival in Older Adult Allogeneic Hematopoietic Cell Transplant Candidates, OTIS Study

Acute Myeloid Leukemia Clinical Trial

Official title:

Optimization of Older Adult Allogeneic Hematopoietic Cell Transplant Candidates to Improve Survival (OTIS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05972577
• Other study ID #: OSU-21010
• Secondary ID: NCI-2021-10004
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Anemia, Aplastic
• Aplastic Anemia
• Chronic Lymphocytic Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Hematopoietic and Lymphoid Cell Neoplasm
• Hodgkin Lymphoma
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Lymphoma
• Multiple Myeloma
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Myelofibrosis
• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Neoplasms
• Non-Hodgkin Lymphoma
• Plasma Cell Myeloma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• Health Promotion and Education
Undergo GO!
• Medical Device Usage and Evaluation
Wear accelerometer
• Quality-of-Life Assessment
Complete quality of life assessments and diary entries
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	At 6 months before transplant, up to 12 months after transplant
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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