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

NCT03902535 | Completed DMC

• 3 other identifiers: 18294NCI-2018-02024P30CA033572
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Percentage of patients with vulnerability using the geriatric assessment

  Up to 6 months post therapy

• Percentage of patients who receive and accept referrals

  Up to 6 months post therapy

• Treatment modification and healthcare utilization in patients

  Up to week 12

• Change in CGA scores and domains

  Baseline up to 6 months post therapy

• Change in physical activity levels

  Baseline up to 6 months post therapy

Study Arms (2)

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: Comprehensive Geriatric Assessment; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

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: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Comprehensive Geriatric Assessment OTHER

Complete comprehensive geriatric assessment

Group I (geriatric and quality of life assessments)

Quality-of-Life Assessment OTHER

Complete quality of life assessment

Also known as: Quality of Life Assessment

Group I (geriatric and quality of life assessments); Group II (quality of life assessment)

Questionnaire Administration OTHER

Complete questionnaires

Group I (geriatric and quality of life assessments); Group II (quality of life assessment)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Arya Amini

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 4, 2019
• Study Start: March 8, 2019
• Primary Completion: June 17, 2022
• Study Completion: June 17, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

US (1)