Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Cancer and Their Family Caregivers

Официальное название

Geriatric Assessment and Management for Older Adults Undergoing Radiation Therapy for Head and Neck Cancer and Their Family Caregivers

Обзор

This clinical trial compares the effect of geriatric assessment (GA)-based management of supportive care to usual care in treating older patients undergoing chemotherapy and radiation therapy for head and neck cancer and their family caregivers (FCG). At least one quarter of head and neck cancers patients are diagnosed at age 70 or older. Treatment for head and neck cancers usually include surgery, chemotherapy, and radiation. Older adults are often at higher risk for functional problems, and may experience more side effects. In addition, there may be a lack of support mechanisms in place to address the needs of these older patients. Cancer not only affects the patients but the entire family, especially the family member who is the caregiver. Currently, all patients over 65 receive the same standard of care based on national guidelines, which include supportive care referrals. However, data suggests, that many patients may need more frequent and structured support. The Practical Geriatric Assessment (PGA) is a complete examination including evaluation of the physical and mental function as well as the emotional state of the older patient. PGA-based supportive care interventions may be safe, tolerable, and/or effective in managing treatment-related side effects and improving quality of life compared to usual care in older patients undergoing chemotherapy and radiation therapy for head and neck cancer and their FCG.

Подробное описание

PRIMARY OBJECTIVE:

I. To evaluate the safety of the intervention by evaluation of treatment-related toxicities.

SECONDARY OBJECTIVES:

I. To assess the feasibility, retention, and acceptability of the intervention. II. To assess the rate of any grade non-hematologic treatment-related toxicities.

III. To assess patient/FCG self-reported outcomes. IV. To assess the symptom-related outcomes by evaluation of unplanned readmissions and emergency room (ER)/urgent care visits.

OUTLINE: Patients are randomized to 1 of 2 arms. Caregivers are randomized to the same arm as the corresponding patients.

ARM A (GA-DRIVEN INTERVENTION): Patients undergo PGA at baseline, at 4 weeks and at 1 month after completing treatment. Assessment results shared with treating oncologists and patients receive referrals to supportive care services for the problems identified with the assessment throughout the study. Caregivers may receive referrals to resources and programs.

ARM B (USUAL CARE): Patients attend regular clinical visits for treatment and follow up and receive usual care provided by their radiation oncology and medical oncology teams and referrals to supportive care services as needed throughout the study.

After completion of study interventions, patients are followed up at 1 and 3 months.

Вмешательства

• Другое Best Practice
  Receive usual care
• Другое Electronic Health Record Review
  Ancillary studies
• Поведенческое Health Communication
  Shared with treating oncology
• Другое Interview
  Ancillary studies
• Другое Office Visit
  Attend regular clinical visits
• Другое Practical Geriatric Assessment
  Undergo PGA
• Другое Questionnaire Administration
  Ancillary studies
• Другое Referral
  Receive referrals to resources and programs
• Другое Referral
  Receive referrals to supportive care services
• Другое Supportive Care
  Receive referrals to supportive care services

Первичные конечные точки

• Proportion of grade 2-5 non-hematologic treatment-related toxicities [Срок оценки: Up to 3 months after completion of treatment]

Вторичные конечные точки (7)

• Percentage of eligible participants who enroll in the study [Срок оценки: Up to 1 year]
• Retention rate [Срок оценки: Up to 3 months after completion of study treatment]
• Acceptability of the intervention [Срок оценки: Up to 3 months after completion of treatment]
• Proportion of any-grade non-hematologic treatment-related toxicities [Срок оценки: Up to 3 months after completion of treatment]
• Patient/family caregiver self-reported outcomes [Срок оценки: Up to 3 months after completion of treatment]
• Rate of unplanned readmissions [Срок оценки: Up to 3 months after completion of treatment]
• Rate of emergency room/urgent care visits [Срок оценки: Up to 3 months after completion of treatment]

Критерии участия

Критерии включения

• PATIENT: Documented written informed consent of the participant
• PATIENT: Diagnosis of non-metastatic head and neck cancer
• PATIENT: Age: ≥ 60 years
• PATIENT: Patient must be scheduled to undergo curative-intent, definitive radiation with or without concurrent chemotherapy or postoperative radiation with or without concurrent chemotherapy
• PATIENT: Patients must have at least one geriatric assessment as assessed by the modified Geriatric 8 (G8) tool
• PATIENT: Family caregivers (FCGs) are highly encouraged to participate but this is not required. Patients without FCGs will be eligible to participate in the study. FCGs will be randomized to the same arm as their corresponding patients
• PATIENT: Ability to read and understand English
• CAREGIVER: A family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care
• CAREGIVER: Ability to read and understand English
• CAREGIVER: Age 18 years or older

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• City of Hope Medical Center — Duarte

Идентификаторы

NCT: NCT07225855 · 22617 · NCI-2025-07662 · 22617 · P30CA033572

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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