Clinical Trials Logo

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.


Clinical Trial 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 Design


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

NCT number NCT03902535
Study type Observational
Source City of Hope Medical Center
Contact
Status Completed
Phase
Start date March 8, 2019
Completion date June 17, 2022

See also
  Status Clinical Trial Phase
Withdrawn NCT04267913 - Testing of TAK228 (MLN0128, Sapanisertib) Plus Docetaxel to the Usual Standard of Care for Advanced Squamous Cell Lung Cancer (A Lung-MAP Treatment Trial) Phase 2
Recruiting NCT04151940 - PET/CT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer N/A
Terminated NCT03707925 - Bronchoscopic Laser Ablation of Peripheral Lung Tumors N/A
Active, not recruiting NCT04081688 - Atezolizumab and Varlilumab in Combination With Radiation Therapy for NSCLC Phase 1
Recruiting NCT04929041 - Testing the Addition of Radiation Therapy to Immunotherapy for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative Phase 2/Phase 3
Active, not recruiting NCT04250545 - Testing of the Anti Cancer Drugs CB-839 HCl (Telaglenastat) and MLN0128 (Sapanisertib) in Advanced Stage Non-small Cell Lung Cancer Phase 1
Terminated NCT04396535 - Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer Phase 2
Active, not recruiting NCT04514497 - Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer Phase 1
Withdrawn NCT05161533 - Hypofractionated Radiation Therapy After Durvalumab and Chemotherapy for the Treatment of Stage IV Extensive Stage Small Cell Lung Cancer, CASPIAN-RT Trial Phase 2
Recruiting NCT04919369 - All-Trans Retinoic Acid (ATRA) and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer Phase 1
Terminated NCT03662074 - Subsequent Line Gemcitabine and Nivolumab in Treating Participants With Metastatic Small Cell Lung Cancer Phase 2
Recruiting NCT04073745 - Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer Phase 1
Withdrawn NCT04186988 - [18F]-AraG for the Detection of T-Cell Activation in Advanced Non-small Cell Lung Cancer Patients Undergoing PD-1/PD-L1-Directed Therapy Early Phase 1
Active, not recruiting NCT03600701 - Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer Phase 2
Active, not recruiting NCT03637816 - Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer Phase 2/Phase 3
Active, not recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Recruiting NCT05234307 - PBF-1129 and Nivolumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer Phase 1
Recruiting NCT06122064 - A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer N/A
Active, not recruiting NCT04533451 - Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer Phase 2
Active, not recruiting NCT03776253 - Conquer Fear SUPPORT Intervention in Supporting Patients With Stage III-IV Lung or Gynecologic Cancer N/A