Geriatric Support Strategies for Head and Neck Cancer

Not currently recruiting at 5 trial locations

Overseen By Nancy Lee, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Geriatrician consultation, Telemedicine inability, Proton therapy, others

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

Compensation: Varies

Number of Visits: 1

Duration: Varies

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two strategies to help older patients manage side effects during chemoradiation therapy for head and neck cancer. The first approach, Geriatric Co-Management, involves collaboration with a geriatrician to address various health needs. The second, Geriatric Guided Supportive Care, uses automated reports to assist oncologists in providing supportive care. The trial seeks participants aged 65 or older who have been diagnosed with head and neck cancer and are about to begin a specific course of radiation and chemotherapy. Participants should not have previously consulted with a geriatrician and must be able to use telemedicine if needed. As an unphased trial, this study offers patients a unique opportunity to contribute to innovative approaches in managing cancer treatment side effects.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these geriatric support strategies are safe for managing side effects in older patients with head and neck cancer?

Research has shown that special care plans for older adults, known as geriatric co-management and geriatric guided supportive care, are generally well-tolerated. One study found that geriatric co-management reduced the risk of hospitalization for older adults receiving chemoradiation therapy. This finding is significant because older adults with head and neck cancer often face complications and longer hospital stays.

For geriatric guided supportive care, research indicates that using assessments to guide care can lessen treatment-related side effects. These assessments identify specific needs, such as physical therapy or mental health support, which can then be addressed to improve patient outcomes.

Overall, both approaches aim to manage side effects and enhance the quality of life for older patients undergoing cancer treatment. While specific side effects or adverse events were not detailed, the focus on personalized care demonstrates a commitment to safety and patient support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for head and neck cancer in older adults because they focus on personalized care strategies alongside standard cancer treatments. Geriatric Co-Management is unique because it involves a geriatrician who tailors care to manage other health issues and medications, ensuring patients receive comprehensive support. Geriatric Guided Supportive Care stands out by using automated reports to identify specific geriatric needs and suggest targeted interventions, like physical therapy or mental health support, which the oncology team then implements. Both approaches aim to improve overall quality of life and treatment outcomes by addressing the unique challenges faced by older cancer patients.

What evidence suggests that this trial's treatments could be effective for managing side effects in older patients with head and neck cancer?

Research has shown that working closely with a geriatric specialist can improve health outcomes for older patients with head and neck cancer. In this trial, participants may receive geriatric co-management, collaborating with a geriatrician to manage other health issues and side effects from cancer treatment. One study found that using special assessments for older adults improved survival and overall health.

Alternatively, participants may receive geriatric-guided supportive care, where geriatric assessments guide supportive care. Studies indicate that these tools can help spot problems early, enabling doctors to create better care plans to address issues like falls or mental health concerns. Both methods aim to improve quality of life by tailoring care to the specific needs of older adults. ^{2 5 6 7 8}

Who Is on the Research Team?

Nancy Lee, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals aged 65 or older with a confirmed diagnosis of head and neck cancer who are about to undergo chemoradiation therapy. Participants must be able to give informed consent, read and understand English, and commit to a 6-7 week course of treatment. Those already consulting with a geriatrician, unable to use telemedicine, or on experimental therapy trials are excluded.

Inclusion Criteria

My cancer is in my mouth, throat, voice box, or the area below my pharynx.

I will undergo a 6-7 week course of radiation and chemotherapy.

Able to read and understand English

Exclusion Criteria

I am undergoing or have undergone proton therapy.

I am not currently on any standard treatments or experimental therapy trials.

I cannot use telemedicine and must visit the clinic in person.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Consultation

Consultation with a geriatrician or oncologist to review eRFA results and create a management plan for geriatric deficits

1 week

1 visit (in-person or virtual)

Treatment

Participants receive head and neck radiation and chemotherapy with either geriatric co-management or geriatric guided supportive care

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Geriatric Co-Management
• Geriatric Guided Supportive Care

Trial Overview The study compares two methods: geriatric co-management versus geriatric guided supportive care in managing side effects for older patients receiving chemoradiation for head and neck cancers. It aims to determine which approach is more effective during the treatment period.

How Is the Trial Designed?

Group I: geriatric guided supportive care Experimental Treatment 1 Intervention

Geriatric guided supportive care will be carried out by oncologists. After the patient completes the eRFA, an automated report is generated that identifies the patient's geriatric deficits. The automated report also includes suggested interventions for each deficit (e.g, referral to physical therapy. For instance, automated suggestions for a patient with a history of falls include consultation with physical therapy, neurologic evaluation, a home safety evaluation, or use of supportive devices. Automated recommendations for patient with high level of distress or depression include referral to psychiatry or social work, involvement in a cancer support group, or additional time spent addressing questions and fears. The oncology team will review the automated report from the eRFA and create an intervention plan prior to initiation of head and neck radiation and chemotherapy.

Group II: geriatric co-management Experimental Treatment 1 Intervention

Geriatric co-management involves a consultation with a geriatrician prior to initiating head and neck radiation and chemotherapy. Consultation with geriatricians can occur in-person or remotely via telemedicine. During this visit, the geriatrician will review the results of the eRFA and create a plan to manage geriatric deficits. Geriatric co-management involves optimization of comorbid conditions, management of polypharmacy, and supportive care referrals to address geriatric deficits. Geriatricians also work in conjunction with the treating oncologists to ensure patients have appropriate pain management and bowel regimens. Additional follow up visits after the initial consultation are at the discretion of the geriatrician may vary between patients depending on the clinical need.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12457382/

Real-world treatment patterns and clinical outcomes ... Approximately 60% of patients with head and neck squamous cell carcinoma (HNSCC) present with locoregionally advanced (LA) disease at diagnosis ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9265581/

Effectiveness of Geriatric Assessment-Driven Interventions on ... Effectiveness of geriatric assessment-driven interventions on survival and functional and nutritional status in older patients with head and neck cancer.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1368837525005937

The low evidence to treat elderly patients with head and ... Treatment of head and neck cancer in older patients is particularly complex, as they are more prone to side effects and treatment-related toxicity due to ...

4. jnccn.org jnccn.org/abstract/journals/jnccn/23/9/article-e257042.xml

Randomized Clinical Trial of Geriatric Comanagement ... The primary endpoint was the rate of hospitalization during CRT. Results: A total of 30 patients were randomized, with 14 ultimately eligible to ...

5. onco-hema.healthbooktimes.org onco-hema.healthbooktimes.org/article/94081

Geriatric Assessment of Older Patients with Cancer This paper focuses on recent data demonstrating the benefits of GA and GA-driven interventions on clinical outcomes of geriatric patients with cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8882127/

Outcomes following Head and Neck Cancer Surgery ... Older adults with head and neck cancer have increased postoperative complications, longer hospital stays, and higher rates of mortality.

7. geriatriconcology.net geriatriconcology.net/article/S1879-4068(24)00169-3/fulltext

Predicting short-term treatment toxicity in head and neck ... The current study confirms that frailty is strongly associated with treatment toxicity in patients undergoing curative-intent HNC therapy.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1879406825001547

Survival and risk factors for death in older adults with ... According to the Finnish Cancer Registry, the age-standardised relative five-year survival of patients with HNC is 65% in men and 77% in women [1]. A recent ...