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

Primary Purpose

Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Aplastic Anemia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Promotion and Education
Medical Device Usage and Evaluation
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Lymphoblastic Leukemia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (GO!)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.

Full Information

First Posted
July 13, 2022
Last Updated
July 24, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05972577
Brief Title
Geriatric Optimization Plan to Improve Survival in Older Adult Allogeneic Hematopoietic Cell Transplant Candidates, OTIS Study
Official Title
Optimization of Older Adult Allogeneic Hematopoietic Cell Transplant Candidates to Improve Survival (OTIS)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Aplastic Anemia, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid Cell Neoplasm, Hodgkin Lymphoma, Myelodysplastic Syndrome, Myelofibrosis, Myeloproliferative Neoplasm, Non-Hodgkin Lymphoma, Plasma Cell Myeloma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (GO!)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Health Promotion and Education
Intervention Description
Undergo GO!
Intervention Type
Other
Intervention Name(s)
Medical Device Usage and Evaluation
Intervention Description
Wear accelerometer
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Complete quality of life assessments and diary entries
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete questionnaires
Primary Outcome Measure Information:
Title
Change in 6-Minute Walk Test distance
Description
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
Secondary Outcome Measure Information:
Title
Change in Short Physical Performance Battery score
Description
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
Title
Change in in Mini Nutritional Assessment score
Description
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
Title
Change in cognitive and mental health
Description
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
Title
Change in cognitive and mental health
Description
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
Title
Change in cognitive and mental health
Description
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
Title
Change in cognitive and mental health
Description
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
Title
Proportion of sample achieving "normal" scores on geriatric assessment tools
Description
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
Title
Time to receipt of transplant
Description
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
Title
Overall survival
Description
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
Title
Non-relapse mortality
Description
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
Title
Adherence to prescribed geriatric optimization plan (GO!) prescription
Description
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
Title
Change in quality of life
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Wall, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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