City of Hope Medical Center
Duarte, California, 91010, United States
NCT Number: NCT03902535
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.
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Notify Me21 year and older
All sexes
Observational
Duarte, California, 91010, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Complete comprehensive geriatric assessment
Complete quality of life assessment
Other names: Quality of Life Assessment
Complete questionnaires
Time frame: Up to 6 months post therapy
Descriptive statistics will be used to summarize all CGA measure scores/domains.
Time frame: Up to 6 months post therapy
Descriptive statistics will be used to summarize all physical activity levels.
Time frame: Up to 6 months post therapy
Descriptive statistics will be used to summarize all QOL measures.
Time frame: 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.
Time frame: Up to 6 months post therapy
Descriptive statistics will be used to summarize all FCG-reported measure scores/domains.
Time frame: 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).
Time frame: 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.
Time frame: Up to week 12
Frequency and reasons for healthcare resource use and treatment modifications will be tabulated.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to 6 months post therapy
Changes will be calculated as post-treatment scores minus pre-treatment scores.
City of Hope Medical Center
Other
Geriatric Assessment and Quality of Life in Older Adults Undergoing Definitive Treatment for Head and Neck or Lung Cancer and Their Informal Caregivers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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