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

Geriatric Assessment and Quality of Life in Older Adults Undergoing Definitive Treatment for Head and Neck or Lung Cancer and Their Informal Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Metastatic Lung Carcinoma; Stage IV Lung Cancer AJCC v8; Head and Neck Carcinoma; Lung Carcinoma; Stage II Lung Cancer AJCC v8; Stage IIA Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB 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 IIIC Lung Cancer AJCC v8; Caregiver; Metastatic Head and Neck Carcinoma; Stage 0 Lung Cancer AJCC v8
• Intervention / Treatment: Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Comprehensive Geriatric Assessment

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.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I (geriatric and quality of life assessments); 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.	Other: Questionnaire Administration; Complete questionnaires; Other: Quality-of-Life Assessment; Complete quality of life assessment; Other Names: Quality of Life Assessment; Other: Comprehensive Geriatric Assessment; Complete comprehensive geriatric assessment
Group II (quality of life assessment); Family caregivers complete quality of life assessment at baseline, and at 1, 3, and 6 months following patient radiation or CRT completion.	Other: Questionnaire Administration; Complete questionnaires; Other: Quality-of-Life Assessment; Complete quality of life assessment; Other Names: Quality of Life Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehensive geriatric assessment (CGA) scores and domains	Descriptive statistics will be used to summarize all CGA measure scores/domains.	Up to 6 months post therapy
Physical activity levels	Descriptive statistics will be used to summarize all physical activity levels.	Up to 6 months post therapy
Quality of life (QOL) measures	Descriptive statistics will be used to summarize all QOL measures.	Up to 6 months post therapy
Incidence and type of grade 2-5 toxicities	Types of grade 2-5 toxicities will be summarized and proportions of patients with grade 2-5 toxicities will be tabulated and reported according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.	Up to week 4
Family caregiver (FCG)-reported caregiving burden level and QOL scores	Descriptive statistics will be used to summarize all FCG-reported measure scores/domains.	Up to 6 months post therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with vulnerability using the geriatric assessment	Percentage of patients with vulnerability will be calculated as the number of patients with vulnerability divided by 30 (target sample).	Up to 6 months post therapy
Percentage of patients who receive and accept referrals	The percentage of patients who receive and accept referrals will be calculated as the number of patients with referral divided by the number of patients with vulnerability.	Up to 6 months post therapy
Treatment modification and healthcare utilization in patients	Frequency and reasons for healthcare resource use and treatment modifications will be tabulated.	Up to week 12
Change in CGA scores and domains	Changes will be calculated as post-treatment scores minus pre-treatment scores. The pattern of changes in CGA assessment will be summarized.	Baseline up to 6 months post therapy
Change in physical activity levels	Will utilize the pedometer to assess physical activity level during and after treatment and record changes. The pattern of changes in physical activity levels will be summarized.	Baseline up to 6 months post therapy
Change in QOL measures	Changes will be calculated as post-treatment scores minus pre-treatment scores. The pattern of changes in QOL measures will be summarized.	Baseline up to 6 months post therapy
Change in FCG-reported caregiving burden level and QOL scores	Changes will be calculated as post-treatment scores minus pre-treatment scores.	Baseline up to 6 months post therapy

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2019
• Primary Completion (Actual): June 17, 2022
• Study Completion (Actual): June 17, 2022

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma
• Other Study ID Numbers: 18294 (Other Identifier: Medical University of SC); P30CA033572 (U.S. NIH Grant/Contract); NCI-2018-02024 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No