Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-02 @ 4:11 AM
Study NCT ID:
NCT03902535
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2019-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 18294 | OTHER | City of Hope Comprehensive Cancer Center | View | |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2018-02024 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |