Clinical trial NCT05972577: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in 6-Minute Walk Test distance
timeFrame: At 6 months before transplant, up to 12 months after transplant
Secondary outcomes:
measure: Change in Short Physical Performance Battery score
timeFrame: At 6 months before transplant, up to 12 months after transplant
measure: Change in in Mini Nutritional Assessment score
timeFrame: At 6 months before transplant, up to 12 months after transplant
measure: Change in cognitive and mental health
timeFrame: At 6 months before transplant, up to 12 months after transplant
measure: Change in cognitive and mental health
timeFrame: At 6 months before transplant, up to 12 months after transplant
measure: Change in cognitive and mental health
timeFrame: At 6 months before transplant, up to 12 months after transplant
measure: Change in cognitive and mental health
timeFrame: At 6 months before transplant, up to 12 months after transplant
measure: Proportion of sample achieving "normal" scores on geriatric assessment tools
timeFrame: At 6 months before transplant, up to 12 months after transplant
measure: Time to receipt of transplant
timeFrame: Up to 1 year after treatment
measure: Overall survival
timeFrame: Up to 12 months after transplant
measure: Non-relapse mortality
timeFrame: Up to 12 months after transplant
measure: Adherence to prescribed geriatric optimization plan (GO!) prescription
timeFrame: Up to 6 months after transplant
measure: Change in quality of life
timeFrame: At 6 months before transplant, 3, and 6 month after transplant
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Sarah Wall, MD
role: PRINCIPAL_INVESTIGATOR
References: