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Trial Title:
Geriatric Optimization Plan to Improve Survival in Older Adult Allogeneic Hematopoietic Cell Transplant Candidates, OTIS Study
NCT ID:
NCT05972577
Condition:
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
Conditions: Official terms:
Lymphoma
Leukemia
Neoplasms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Multiple Myeloma
Myelodysplastic Syndromes
Myeloproliferative Disorders
Anemia, Aplastic
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Health Promotion and Education
Description:
Undergo GO!
Arm group label:
Supportive care (GO!)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Wear accelerometer
Arm group label:
Supportive care (GO!)
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Complete quality of life assessments and diary entries
Arm group label:
Supportive care (GO!)
Other name:
Quality of Life Assessment
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Complete questionnaires
Arm group label:
Supportive care (GO!)
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.
Criteria for 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
Gender:
All
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Start date:
June 2, 2021
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05972577
http://cancer.osu.edu
