Geriatric Care Optimization for Blood Cancers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Dementia, No transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a personalized geriatric optimization plan can improve life and survival for individuals over 60 with blood cancers or bone marrow issues who qualify for a bone marrow transplant. The plan involves specific changes to daily habits such as diet, sleep, and physical activity, and may include new medications or referrals to other doctors. Participants must attend several study visits, complete monthly questionnaires, and wear a fitness tracker for up to six months. This trial suits those over 60 who can communicate in English, have certain blood-related conditions, and qualify for a bone marrow transplant. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance the quality of life for older adults.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. It focuses on creating a personalized plan, which might include changes to your medicines, but this would depend on your specific needs.

What prior data suggests that the geriatric optimization plan is safe for patients over 60 with blood cancers?

Research has shown that personalized care plans for older adults with blood cancers are generally well-tolerated. These plans address the specific needs of older patients and include lifestyle changes such as diet and exercise. Although studies do not specify particular side effects, this approach is considered safe and aims to enhance daily life and quality of life without causing harm. Furthermore, the trial's "Not Applicable" phase indicates that the treatment is expected to be safe, as it does not involve a new drug or invasive procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Geriatric Optimization Plan (GO!) is unique because it tailors care specifically for older adults with blood cancers, addressing their complex needs beyond just the cancer itself. Unlike traditional treatment options that primarily focus on chemotherapy or targeted drugs, GO! emphasizes personalized supportive care through regular study visits, monthly questionnaires, and the use of accelerometers to monitor physical activity. Researchers are excited about this approach because it aims to improve overall quality of life and potentially enhance treatment outcomes for geriatric patients by considering their holistic health needs.

What evidence suggests that the Geriatric Optimization Plan is effective for improving survival in patients over 60 with blood cancers?

Research has shown that special care plans for older adults can benefit those with blood cancers. In this trial, participants will receive a personalized Geriatric Optimization Plan (GO!), which includes study visits and assessments tailored to individual needs. One study found that using a geriatric assessment, which evaluates an older person's overall health, improved their care. This method focuses on meeting unique needs, such as adjusting diet, sleep, and activity levels. Another study found that these personalized plans can help prepare older patients for treatments like CAR-T therapy, a type of cancer treatment. These findings suggest that a geriatric care plan can enhance treatment effectiveness and improve the quality of life for older patients. ^{1 2 3 5 6}

Who Is on the Research Team?

Sarah Wall, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for people over 60 with blood cancers or bone marrow failure who are eligible for a stem cell transplant. They must be able to understand English and commit to the study's full duration. Those with dementia, no transplant planned within 6 months, or a scheduled transplant within 30 days can't join.

Inclusion Criteria

I am eligible for a stem cell transplant due to my blood-related cancer or condition.

I am willing to follow the study's schedule and procedures.

I am 60 years old or older.

Exclusion Criteria

I am not eligible for a bone marrow transplant from a donor within the next 6 months.

Inability or unwillingness to give written informed consent

I am scheduled for a stem cell transplant from a donor within the next 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Geriatric Optimization (GO!) Plan

Participants undergo a personalized geriatric optimization plan with study visits and monthly questionnaires

6 months

Monthly visits (in-person or virtual)

Transplant Preparation

Participants are prepared for allogeneic hematopoietic cell transplant, including hospital admission

Up to 6 months

Follow-up

Participants are monitored for safety and effectiveness after transplant

12 months

Visits at 3, 6, and 12 months post-transplant

What Are the Treatments Tested in This Trial?

Interventions

• Geriatric Optimization Plan

Trial Overview

The OTIS Study tests a geriatric optimization plan (GO!) aimed at improving survival in older adults through personalized lifestyle changes like diet, sleep, activity adjustments, medication reviews, and specialist referrals before their stem cell transplants.

How Is the Trial Designed?

Group I: Supportive care (GO!) Experimental Treatment 4 Interventions

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.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

Collaboration between oncologists and geriatricians is crucial for assessing risks in elderly cancer patients, focusing on vulnerability, potential death, and severe side effects from chemotherapy.

Utilizing comprehensive geriatric assessments and predictive scores allows for a thorough evaluation of elderly patients, helping to inform treatment decisions in a multidimensional way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Risk assessment in medical geriatric oncology]. Pamoukdjian, F., Ferreira, A.[2019]

Geriatric assessment (GA) is crucial for older cancer patients to identify unaddressed health issues and improve functional status, which may enhance survival rates; this is particularly important as the number of older cancer patients increases.

The Geriatrics Service at Memorial Sloan Kettering Cancer Center emphasizes a patient-centered approach, integrating GA into cancer treatment planning and highlighting the benefits of co-management between oncologists and geriatric specialists to address both cancer and non-cancer-related needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How We Care for an Older Patient With Cancer. Shahrokni, A., Kim, SJ., Bosl, GJ., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11241324/

Hematological Malignancies in Older Patients

In this review, we evaluated the possible application of geriatric assessment management (GAM) in hematological malignancies. In older patients ...

2.

ashpublications.org

ashpublications.org/bloodadvances/article/8/14/3785/516267/Optimization-of-older-adults-by-a-geriatric

Optimization of older adults by a geriatric assessment–guided ...

We explored the role of a geriatric assessment (GA)–guided multidisciplinary clinic (GA-MDC) in selecting and optimizing older adults for CAR-T. Sixty-one ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/EDBK_320141

Caring for Older Adults With Hematologic Malignancies

In this article, we will cover approaches to the care of older adults with blood cancers, which includes addressing the presence of geriatric impairments.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11298834/

Optimization of older adults by a geriatric assessment–guided ...

We explored the role of a geriatric assessment (GA)–guided multidisciplinary clinic (GA-MDC) in selecting and optimizing older adults for CAR-T.

5.

ascopubs.org

ascopubs.org/doi/10.1200/EDBK_432220

Tailoring Therapy in Older Adults With Hematologic ...

Here, we review the data supporting GA for the care of older adults with blood cancers, from the community to the academic center. In addition, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12577986/

Aging with leukemia: public health strategies for optimizing ...

This review examines public health strategies aimed at optimizing QoL and palliative care delivery for older adults with refractory leukemia.