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

Purpose

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.

Condition

  • Localized Head and Neck Carcinoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Criteria

Inclusion Criteria:

- 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Other: Electronic Health Record Review
    Ancillary studies
  • Behavioral: Health Communication
    Shared with treating oncology
  • Other: Interview
    Ancillary studies
  • Other: Practical Geriatric Assessment
    Undergo PGA
  • Other: Questionnaire Administration
    Ancillary studies
  • Other: Referral
    Receive referrals to resources and programs
    Other names:
    • Referred
  • Other: Supportive Care
    Receive referrals to supportive care services
    Other names:
    • Supportive Therapy
    • Symptom Management
    • Therapy, Supportive
Active Comparator
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.
  • Other: Best Practice
    Receive usual care
    Other names:
    • standard of care
    • standard therapy
  • Other: Electronic Health Record Review
    Ancillary studies
  • Other: Office Visit
    Attend regular clinical visits
  • Other: Questionnaire Administration
    Ancillary studies
  • Other: Referral
    Receive referrals to supportive care services
    Other names:
    • Referred

Recruiting Locations

City of Hope Medical Center
Duarte, California 91010
Contact:
Arya Amini
626-218-2247
aamini@coh.org

More Details

Status
Recruiting
Sponsor
City of Hope Medical Center

Study Contact

Detailed Description

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.