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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Acute Myeloid Leukemia; Hodgkin Lymphoma; Myelofibrosis; Acute Lymphoblastic Leukemia; Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma; Myelodysplastic Syndrome; Plasma Cell Myeloma; Aplastic Anemia; Myeloproliferative Neoplasm; Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Intervention / Treatment: Other: Questionnaire Administration; Other: Medical Device Usage and Evaluation; Other: Health Promotion and Education; Other: Quality-of-Life Assessment

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Questionnaire Administration; Complete questionnaires; Other: Medical Device Usage and Evaluation; Wear accelerometer; Other: Health Promotion and Education; Undergo GO!; Other: Quality-of-Life Assessment; Complete quality of life assessments and diary entries; Other Names: Quality of Life Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Sarah Wall, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Bone Marrow Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Anemia; Neoplasms, Plasma Cell; Leukemia, Lymphoid; Leukemia, B-Cell; Bone Marrow Failure Disorders; Chronic Disease; Neoplasms; Lymphoma; Myelodysplastic Syndromes; Multiple Myeloma; Leukemia; Leukemia, Myeloid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myeloproliferative Disorders; Anemia, Aplastic
• Other Study ID Numbers: OSU-21010; NCI-2021-10004 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No