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

Stage IV Lung Cancer AJCC v8 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902535
• Other study ID #: 18294
• Secondary ID: NCI-2018-0202418
• Status: Completed
• Start date: March 8, 2019
• Est. completion date: June 17, 2022

Study information

• Verified date: February 2023
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 17, 2022
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Caregiver
• Head and Neck Carcinoma
• Lung Carcinoma
• Lung Neoplasms
• 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

Intervention

Other:
• Comprehensive Geriatric Assessment
Complete comprehensive geriatric assessment
• Quality-of-Life Assessment
Complete quality of life assessment
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Physical activity levels	Descriptive statistics will be used to summarize all physical activity levels.	Up to 6 months post therapy
Primary	Quality of life (QOL) measures	Descriptive statistics will be used to summarize all QOL measures.	Up to 6 months post therapy
Primary	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
Primary	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	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
Secondary	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
Secondary	Treatment modification and healthcare utilization in patients	Frequency and reasons for healthcare resource use and treatment modifications will be tabulated.	Up to week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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