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

Completed

• Conditions: Head and Neck Carcinoma; Stage IB Lung Cancer AJCC v8; Lung Carcinoma; Stage IIIA Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Caregiver; Metastatic Head and Neck Carcinoma; Stage IA1 Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8
• Interventions: Other: Comprehensive Geriatric Assessment; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT03902535
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study Start: 2019-03-08
• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-04
• Primary Completion: 2022-06-17
• Study Completion: 2022-06-17
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group II (quality of life assessment)	Questionnaire Administration	Family caregivers complete quality of life assessment at baseline, and at 1, 3, and 6 months following patient radiation or CRT completion.
Group I (geriatric and quality of life assessments)	Comprehensive Geriatric Assessment	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 I (geriatric and quality of life assessments)	Questionnaire Administration	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 (quality of life assessment)	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.
Group I (geriatric and quality of life assessments)	Quality-of-Life Assessment	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.

Primary Outcome Measures

Name	Time	Method
Comprehensive geriatric assessment (CGA) scores and domains	Up to 6 months post therapy	Descriptive statistics will be used to summarize all CGA measure scores/domains.
Physical activity levels	Up to 6 months post therapy	Descriptive statistics will be used to summarize all physical activity levels.
Quality of life (QOL) measures	Up to 6 months post therapy	Descriptive statistics will be used to summarize all QOL measures.
Incidence and type of grade 2-5 toxicities	Up to week 4	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.
Family caregiver (FCG)-reported caregiving burden level and QOL scores	Up to 6 months post therapy	Descriptive statistics will be used to summarize all FCG-reported measure scores/domains.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States