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

NCT05972577 | Active Not Recruiting DMC

• 2 other identifiers: OSU-21010NCI-2021-10004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in Short Physical Performance Battery score

  At 6 months before transplant, up to 12 months after transplant

• Change in in Mini Nutritional Assessment score

  At 6 months before transplant, up to 12 months after transplant

• Change in cognitive and mental health

  At 6 months before transplant, up to 12 months after transplant

• Change in cognitive and mental health

  At 6 months before transplant, up to 12 months after transplant

• Change in cognitive and mental health

  At 6 months before transplant, up to 12 months after transplant

Study Arms (1)

Supportive care (GO!)

EXPERIMENTAL

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: Health Promotion and Education; Other: Medical Device Usage and Evaluation; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Health Promotion and Education OTHER

Undergo GO!

Supportive care (GO!)

Medical Device Usage and Evaluation OTHER

Wear accelerometer

Supportive care (GO!)

Quality-of-Life Assessment OTHER

Complete quality of life assessments and diary entries

Also known as: Quality of Life Assessment

Supportive care (GO!)

Questionnaire Administration OTHER

Complete questionnaires

Supportive care (GO!)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Anemia, Aplastic; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hematologic Neoplasms; Hodgkin Disease; Myelodysplastic Syndromes; Primary Myelofibrosis; Myeloproliferative Disorders; Lymphoma, Non-Hodgkin; Multiple Myeloma

Interventions

Health Promotion; Educational Status

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Anemia; Bone Marrow Failure Disorders; Bone Marrow Diseases; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Sarah Wall, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: August 2, 2023
• Study Start: June 2, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)