Clinical trial NCT03902535: Geriatric and Quality of Life Assessments in Older Patients With Non-metastatic or Metastatic Head and Neck or Lung Cancer Undergoing Surgery or Chemoradiation and Their Caregivers
Official title: Geriatric Assessment and Quality of Life in Older Adults Undergoing Definitive Treatment for Head and Neck or Lung Cancer and Their Informal Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caregiver
Head and Neck Carcinoma
Lung Carcinoma
Metastatic Head and Neck Carcinoma
Metastatic Lung Carcinoma
Stage 0 Lung Cancer AJCC v8
Stage I Lung Cancer AJCC v8
Stage IA1 Lung Cancer AJCC v8
Stage IA2 Lung Cancer AJCC v8
Stage IA3 Lung Cancer AJCC v8
Stage IB Lung Cancer AJCC v8
Stage II Lung Cancer AJCC v8
Stage IIA Lung Cancer AJCC v8
Stage IIB Lung Cancer AJCC v8
Stage III Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Stage IIIB Lung Cancer AJCC v8
Stage IIIC Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8
Stage IVB Lung Cancer AJCC v8
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-04-04
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are scheduled to undergo upfront surgery or concurrent CRT for non-metastatic head and neck cancer and family caregivers

Brief summary: This trial studies comprehensive geriatric and quality of life assessments in older patients with head and neck or lung cancer that has or has not spread to other parts of the body who are undergoing standard surgery or chemoradiation, and their caregivers. Comprehensive geriatric assessment may improve the quality of life of patients with head and neck or lung cancer and their caregivers.

Detailed description: PRIMARY OBJECTIVES:

I. To describe the patterns and distribution of comprehensive geriatric assessment (CGA) scores and physical activity levels and quality of life measures in older (\>= 65) patients with non-metastatic or metastatic head and neck or lung cancer undergoing upfront surgery followed (may be followed by adjuvant therapy) or upfront definitive radiation (with or without chemotherapy at the same time) to cure the disease.

II. To describe the incidence and type of grade 2-5 toxicities in this patient population.

III. To describe the family caregiver (FCG)-reported caregiving burden level and quality of life (QOL) scores.

SECONDARY OBJECTIVES:

I. To identify areas of vulnerability in this patient population using the geriatric assessment.

II. To identify potential referrals based on geriatric assessment results. III. To describe other healthcare resource use and potential treatment modifications (unplanned hospitalization, emergency room (ER) visits, readmission rates, breaks in radiation and/or chemoradiation (CRT), dose modifications).

IV. To explore changes in geriatric assessment and patient-reported symptoms, QOL, weight, and functional status from pre-treatment to 3-months, 6 months post-treatment.

V. To explore changes in family caregiver (FCG)-reported caregiving burden and QOL from pre-treatment to 3-months, 6 months post-treatment.

VI. To explore the relationship between geriatric assessment results and patient-reported symptoms and QOL.

OUTLINE: Participants are assigned to 1 of 2 groups.

GROUP I: Patients complete comprehensive geriatric and quality of life assessments within 1-4 weeks of treatment (either upfront surgery which may be followed by radiation with or without chemotherapy or upfront radiation which may include CRT) initiation (baseline), and at 1, 3, and 6 months following CRT completion.

GROUP II: Family caregivers complete quality of life assessment at baseline, and at 1, 3, and 6 months following patient radiation or CRT completion.

Eligibility criteria: Inclusion Criteria:

* PATIENT: Diagnosed with non-metastatic or metastatic head and neck cancer or lung cancer
* PATIENT: Scheduled to undergo either upfront surgery or definitive radiation treatment (including CRT)
* PATIENT: Age \>= 65 years
* PATIENT: Able to read and understand English
* FAMILY CAREGIVER: Family member/friend identified by the patient as the primary caregiver before and after surgery and/or radiation (including CRT)
* FAMILY CAREGIVER: Age \>= 21 years
* FAMILY CAREGIVER: Able to read and understand English
* ALL SUBJECTS: Must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Patients should not have any uncontrolled illness including ongoing or active infection
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Primary outcomes:
measure: Comprehensive geriatric assessment (CGA) scores and domains
timeFrame: Up to 6 months post therapy
measure: Physical activity levels
timeFrame: Up to 6 months post therapy
measure: Quality of life (QOL) measures
timeFrame: Up to 6 months post therapy
measure: Incidence and type of grade 2-5 toxicities
timeFrame: Up to week 4
measure: Family caregiver (FCG)-reported caregiving burden level and QOL scores
timeFrame: Up to 6 months post therapy
Secondary outcomes:
measure: Percentage of patients with vulnerability using the geriatric assessment
timeFrame: Up to 6 months post therapy
measure: Percentage of patients who receive and accept referrals
timeFrame: Up to 6 months post therapy
measure: Treatment modification and healthcare utilization in patients
timeFrame: Up to week 12
measure: Change in CGA scores and domains
timeFrame: Baseline up to 6 months post therapy
measure: Change in physical activity levels
timeFrame: Baseline up to 6 months post therapy
measure: Change in QOL measures
timeFrame: Baseline up to 6 months post therapy
measure: Change in FCG-reported caregiving burden level and QOL scores
timeFrame: Baseline up to 6 months post therapy
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Arya Amini
role: PRINCIPAL_INVESTIGATOR
References: