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Completed

NCT Number: NCT03902535

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive Geriatric Assessment

Other

Complete comprehensive geriatric assessment

Quality-of-Life Assessment

Other

Complete quality of life assessment

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Complete questionnaires

Primary outcomes

  1. Comprehensive geriatric assessment (CGA) scores and domains

    Time frame: Up to 6 months post therapy

    Descriptive statistics will be used to summarize all CGA measure scores/domains.

  2. Physical activity levels

    Time frame: Up to 6 months post therapy

    Descriptive statistics will be used to summarize all physical activity levels.

  3. Quality of life (QOL) measures

    Time frame: Up to 6 months post therapy

    Descriptive statistics will be used to summarize all QOL measures.

  4. Incidence and type of grade 2-5 toxicities

    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.

  5. Family caregiver (FCG)-reported caregiving burden level and QOL scores

    Time frame: Up to 6 months post therapy

    Descriptive statistics will be used to summarize all FCG-reported measure scores/domains.

Secondary outcomes

  1. Percentage of patients with vulnerability using the geriatric assessment

    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).

  2. Percentage of patients who receive and accept referrals

    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.

  3. Treatment modification and healthcare utilization in patients

    Time frame: Up to week 12

    Frequency and reasons for healthcare resource use and treatment modifications will be tabulated.

  4. Change in CGA scores and domains

    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.

  5. Change in physical activity levels

    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.

  6. Change in QOL measures

    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.

  7. Change in FCG-reported caregiving burden level and QOL scores

    Time frame: Baseline up to 6 months post therapy

    Changes will be calculated as post-treatment scores minus pre-treatment scores.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Geriatric Assessment and Quality of Life in Older Adults Undergoing Definitive Treatment for Head and Neck or Lung Cancer and Their Informal Caregivers

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2019
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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