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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the Geriatric Optimization Plan treatment for blood cancers?

Research shows that using a geriatric assessment (a thorough health evaluation) for older cancer patients helps identify unaddressed issues and tailor treatments to improve outcomes. This approach, which is part of the Geriatric Optimization Plan, has been shown to help manage treatment-related complications and align care with patient preferences, potentially improving survival and quality of life. ^{1 2 3 4 5}

Is the Geriatric Care Optimization for Blood Cancers treatment safe for humans?

The research suggests that older adults with cancer, even with careful assessment and personalized treatment, are at high risk of experiencing side effects from chemotherapy. Geriatric assessments can help identify risks and guide treatment decisions, but there is still a significant chance of treatment-related toxicity, such as dose reductions, delays, or hospitalizations. ^{6 7 8 9 10}

How is the Geriatric Optimization Plan treatment different from other treatments for blood cancers in older adults?

The Geriatric Optimization Plan is unique because it uses a geriatric assessment to tailor treatment specifically for older adults with blood cancers, helping to minimize side effects and improve outcomes by considering individual health status and vulnerabilities. ^{7 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Sarah Wall, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Optimizing the geriatrician's contribution to cancer care for older patients. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

How We Care for an Older Patient With Cancer. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Geriatric Oncology Program Development and Gero-Oncology Nursing. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Socioeconomic Considerations and Shared-Care Models of Cancer Care for Older Adults. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Caring for the Older Cancer Patient: Comprehensive Geriatric Evaluation. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Development of a decision tree for the pharmacy-led consultation of elderly patients with haematological malignancies. [2023]

7. Italy pubmed.ncbi.nlm.nih.gov

Geriatric assessment in older patients with a hematologic malignancy: a systematic review. [2021]

8. France pubmed.ncbi.nlm.nih.gov

[Risk assessment in medical geriatric oncology]. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Chemotherapy Toxicity in Older Adults Optimized by Geriatric Assessment and Intervention: A Non-Comparative Analysis. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Geriatric consultation can aid in complex treatment decisions for elderly cancer patients. [2022]

11. Thailand pubmed.ncbi.nlm.nih.gov

Hospitalization risk according to geriatric assessment and laboratory parameters in elderly hematologic cancer patients. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

[Geriatric assessment of patients with hematological neoplasms]. [2018]

13. Japan pubmed.ncbi.nlm.nih.gov

[Risk Assessment of Hematologic Malignancy Treatment of the Elderly]. [2018]

14. Korea (South) pubmed.ncbi.nlm.nih.gov

Geriatric oncology: an overview of progresses and challenges. [2021]