Telemedicine-Geriatric Care for Cancer

Recruiting at 2 trial locations

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Non-compliance, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 months

216 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates whether geriatric assessment-driven interventions with supportive care (GAIN-S) using telemedicine can be used to identify areas of vulnerability (weakness) in older adults with cancer and guide interventions to assist the patient and the healthcare team in the underserved community. The majority of patients diagnosed with cancer are over age 65 years, yet most cancer treatments are developed and tested in a younger population. Therefore, older patients with cancer are less likely to be offered standard treatments because of the concern regarding side effects. Geriatric assessment (GA) is a multi-dimensional health assessment tool combining patient reported and objective (unbiased) results. There is no standard tool that can identify which older adults will be more likely to have side effects from cancer treatment. Telemedicine is a way to provide healthcare services (including consultations, education, care management and treatment) in which the health care provider is at a distant site. The goal of this project is to use telemedicine to identify areas of vulnerability/weakness in older adults with cancer using a patient assessment, and to identify the potential referrals to a multi-specialty team based on patient assessment results. Information gathered from this study may help researchers learn whether GAIN-S can be performed using telemedicine and lead to improvement in care for older adults compared to standard of care (SOC) in the underserved community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment Telemedicine, Telehealth, Virtual Care, Remote Healthcare, E-Health for cancer care in older adults?

Research shows that using geriatric assessments (evaluations of older adults' health) in cancer care can help predict outcomes and improve treatment decisions. This suggests that telemedicine, which can facilitate these assessments remotely, may be effective in managing cancer care for older adults by addressing their unique health needs. ^{1 2 3 4 5}

Is telemedicine safe for elderly cancer patients?

The research does not provide specific safety data on telemedicine for elderly cancer patients, but it highlights the importance of careful medication management to reduce adverse drug events in this population. ^{6 7 8 9 10}

How does the Telemedicine treatment for cancer in elderly patients differ from other treatments?

Telemedicine for cancer care in elderly patients is unique because it allows for remote healthcare, enabling continuous monitoring and support without the need for frequent in-person visits. This approach can be particularly beneficial for older adults who may have mobility issues or live far from healthcare facilities, ensuring they receive timely and personalized care tailored to their specific health and functional status. ^{2 11 12 13 14}

Research Team

William Dale

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for adults aged 65 or older with stage I-IV cancer, about to start new therapy (chemotherapy, immunotherapy, targeted therapy). They must be able to read English, Spanish, or Chinese and have their physician's approval. Those who may not follow study procedures are excluded.

Inclusion Criteria

Ability to read English, Spanish, or Chinese. Other languages will be acceptable with site principal investigator (PI) agreement if surveys are available, and language does not preclude completing study procedures

I am 65 years old or older.

My cancer is between stage I and IV.

Exclusion Criteria

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete the Cancer and Aging Research Group-Geriatric Assessment (CARG-GA) at baseline

1 week

1 visit (virtual)

Treatment

Participants receive GA-based interventions using telemedicine over 6 months

6 months

Monthly virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Telemedicine

Trial Overview The GAIN-S Trial tests if telemedicine can improve care for older adults with cancer in underserved areas by using geriatric assessments to identify vulnerabilities and guide supportive interventions compared to standard care.

Participant Groups

Group I: ARM I (GAIN-S) Experimental Treatment 6 Interventions

Patients complete the CARG-GA at baseline and 3 months and receive GA-based interventions using telemedicine over 6 months.

Group II: ARM II (SOC) Active Control 4 Interventions

Receive SOC over the first 3 months, then switch to receive GA-based interventions using telemedicine for the following 3 months. Patients complete the CARG-GA at baseline and 3 months and receive SOC over 6 months.

Telemedicine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Telemedicine for:

• General medical consultations
• Chronic disease management
• Urgent care needs

Approved in European Union as Telemedicine for:

• General medical consultations
• Chronic disease management
• Urgent care needs

Approved in Canada as Telemedicine for:

• General medical consultations
• Chronic disease management
• Urgent care needs

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study involving 197 older patients with solid tumors, implementing a nurse-led geriatric assessment (GA) and patient preference evaluation led to treatment recommendations differing from the tumor board's suggestions in 27% of cases, often favoring less intensive treatment options.

The onco-geriatric multidisciplinary team (MDT) approach not only adjusted treatment plans for many patients but also resulted in 13% of patients being referred to a geriatrician for further evaluation, highlighting the importance of tailored care in older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to incorporate geriatric assessment in clinical decision-making for older patients with cancer. An implementation study. Festen, S., Kok, M., Hopstaken, JS., et al.[2020]

Geriatric oncology focuses on the comprehensive management of elderly cancer patients, treating their health issues alongside cancer, rather than being a separate subspecialty.

Elderly patients are screened for health problems using specific tools, and treatment decisions are adapted based on their overall health status, emphasizing the need for tailored approaches and specific clinical trials in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Definition and outline on geriatric oncology]. Terret, C., Droz, JP.[2010]

In a study of 2105 older adults (average age 76) with poor prognosis cancers, a significant prevalence of geriatric and palliative care needs was identified, including 65% experiencing difficulty climbing stairs and 36% having fallen in the last two years.

The findings suggest that all older adults with poor prognosis cancers should be routinely assessed for these conditions, as many lack advance directives and experience high rates of functional impairment and pain, particularly among women and those aged 85 and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The epidemiology of preexisting geriatric and palliative conditions in older adults with poor prognosis cancers. Tsang, M., Gan, S., Boscardin, WJ., et al.[2023]

In a study of 191 elderly cancer patients (average age 81.5), the Geriatric Oncology Consultation showed excellent agreement with the Tumor Board's treatment recommendations, particularly in supportive care, but less so for chemotherapy and targeted therapies.

Despite good concordance between proposed treatments and actual care, the final treatment decisions, especially regarding chemotherapy, were often influenced by oncologists, indicating their critical role in managing elderly patients' cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of the geriatric oncology consultation on the final therapeutic decision in elderly subjects with cancer: analysis of 191 patients. Blanc, M., Dialla, O., Manckoundia, P., et al.[2021]

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]

The MOVING program, a virtual interdisciplinary geriatric consultation service, effectively reduced the number of potentially inappropriate medications prescribed to older adults, with significant decreases noted in prescriptions identified by the Beers and STOPP criteria.

While the overall number of prescriptions did not significantly change, the program led to a notable reduction in 'as needed' prescriptions, suggesting improved medication management for older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a Medication Optimization Virtual Interdisciplinary Geriatric Specialist (MOVING) Program: A Feasibility Study. Ho, JM., To, E., Sammy, R., et al.[2023]

In a study of 132 patients treated with capecitabine, those over 70 years experienced significantly more serious adverse effects, such as hand-foot syndrome and diarrhea, compared to younger patients, indicating a need for careful monitoring in older populations.

The study found that dosage adjustments were more common in older patients (52 out of 63) compared to younger patients (27 out of 69), suggesting that age-related factors may influence the safety and effectiveness of capecitabine in geriatric oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Adverse Effects of Capecitabine Toxicity in an Elderly Population. van Beek, MWH., Roukens, M., Jacobs, WCH., et al.[2020]

In a study of 256 elderly patients receiving home health services after hospital discharge, 20% reported experiencing adverse drug events (ADEs), with the most common effects on the gastrointestinal and central nervous systems.

Women and patients with lower cognitive function who were prescribed multiple new medications were at a higher risk for ADEs, highlighting the need for careful medication management in these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events in elderly patients receiving home health services following hospital discharge. Gray, SL., Mahoney, JE., Blough, DK.[2017]

Geriatric patients are at a higher risk for adverse drug events due to changes in how their bodies process medications (pharmacokinetics) and how medications affect their bodies (pharmacodynamics).

Careful selection of medications and appropriate dosage adjustments can significantly reduce the risk of medication-related adverse events in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacology for the geriatric surgical patient. Then, J., Tisherman, SA.[2015]

In a study of 420 elderly cancer patients, 84.3% were prescribed at least one medication with anticholinergic properties, indicating a high prevalence of potentially harmful prescribing practices.

Nearly half of the patients (46.2%) were at high risk for adverse events due to anticholinergic load, highlighting the need for safer prescribing strategies and deprescribing of inappropriate medications to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticholinergic burden risk and prevalence of medications carrying anticholinergic properties in elderly cancer patients in Jordan. Al-Azayzih, A., Jarab, AS., Bani-Ahmad, E., et al.[2023]

Elderly patients (65 years and older) represent the fastest growing segment of the US population and are significantly affected by cancer, which is a leading cause of death in this age group.

There is a critical need for clinical trials focused on elderly cancer patients to better understand treatment side effects and palliative care, as well as the development of tools to predict chemotherapy toxicity and improve patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geriatric oncology and palliative medicine. Haddad, A., Shepard, D.[2011]

Geriatric oncology focuses on the specialized management of older cancer patients, utilizing comprehensive geriatric assessments to address their complex medical needs.

Current research aims to identify key geriatric variables for clinical trials and develop screening tools to assess frailty in older cancer patients, ultimately improving their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current views in geriatric oncology]. Terret, C., Gaujard, S., Droz, JP.[2009]

Geriatric oncology emphasizes a multidimensional approach to treating elderly cancer patients, focusing on principles like autonomy and non-maleficence, which guide treatment objectives and management.

Comprehensive geriatric assessments are crucial for identifying functional issues in elderly patients, and treatment plans must be personalized, highlighting the need for collaboration between oncologic and geriatric teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statements on the interdependence between the oncologist and the geriatrician in geriatric oncology. Terret, C., Zulian, G., Droz, JP.[2005]

Geriatric oncology ambulatory care clinics (GOACCs) are essential for providing specialized care to older cancer patients, focusing on comprehensive geriatric assessments (CGA) and multidisciplinary teams (MDTs) to tailor treatment based on health and functional status rather than just age.

Key roles in establishing and maintaining GOACCs include oncology nurses and advanced practice nurses, who help manage comorbidities, support caregivers, and conduct CGAs, ensuring that older patients receive appropriate and effective cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Geriatrics Into Oncology Ambulatory Care Clinics Overcash, J.[2019]

References

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

How to incorporate geriatric assessment in clinical decision-making for older patients with cancer. An implementation study. [2020]

2. France pubmed.ncbi.nlm.nih.gov

[Definition and outline on geriatric oncology]. [2010]

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

The epidemiology of preexisting geriatric and palliative conditions in older adults with poor prognosis cancers. [2023]

4. France pubmed.ncbi.nlm.nih.gov

Influence of the geriatric oncology consultation on the final therapeutic decision in elderly subjects with cancer: analysis of 191 patients. [2021]

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

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

Outcomes of a Medication Optimization Virtual Interdisciplinary Geriatric Specialist (MOVING) Program: A Feasibility Study. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Real-World Adverse Effects of Capecitabine Toxicity in an Elderly Population. [2020]

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

Adverse drug events in elderly patients receiving home health services following hospital discharge. [2017]

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

Pharmacology for the geriatric surgical patient. [2015]

10. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Anticholinergic burden risk and prevalence of medications carrying anticholinergic properties in elderly cancer patients in Jordan. [2023]

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

Geriatric oncology and palliative medicine. [2011]

12. France pubmed.ncbi.nlm.nih.gov

[Current views in geriatric oncology]. [2009]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Statements on the interdependence between the oncologist and the geriatrician in geriatric oncology. [2005]

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

Integrating Geriatrics Into Oncology Ambulatory Care Clinics [2019]