CaregiverNCT03902535
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
An observational study of Caregiver and Head and Neck Carcinoma, run by City of Hope Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver, Head and Neck Carcinoma, Lung Carcinoma
- What is being tested?
- Comprehensive Geriatric Assessment, Quality-of-Life Assessment and Questionnaire Administration
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2019to 17 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are scheduled to undergo upfront surgery or concurrent CRT for non-metastatic head and neck cancer and family caregivers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
- Conditions
- Caregiver, Head and Neck Carcinoma, Lung Carcinoma, Metastatic Head and Neck Carcinoma, Metastatic Lung Carcinoma, Stage 0 Lung Cancer AJCC v8
- Being tested
- Comprehensive Geriatric Assessment, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Geriatric AssessmentOther
Complete comprehensive geriatric assessment
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete quality of life assessment
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive geriatric assessment (CGA) scores and domains
Descriptive statistics will be used to summarize all CGA measure scores/domains.
Measured: Up to 6 months post therapy
Physical activity levels
Descriptive statistics will be used to summarize all physical activity levels.
Measured: Up to 6 months post therapy
Quality of life (QOL) measures
Descriptive statistics will be used to summarize all QOL measures.
Measured: 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.
Measured: 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.
Measured: Up to 6 months post therapy
Secondary outcomes (7)
Percentage of patients with vulnerability using the geriatric assessment
Percentage of patients with vulnerability will be calculated as the number of patients with vulnerability divided by 30 (target sample).
Measured: Up to 6 months post therapy
Percentage of patients who receive and accept referrals
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.
Measured: Up to 6 months post therapy
Treatment modification and healthcare utilization in patients
Frequency and reasons for healthcare resource use and treatment modifications will be tabulated.
Measured: Up to week 12
Change in CGA scores and domains
Changes will be calculated as post-treatment scores minus pre-treatment scores. The pattern of changes in CGA assessment will be summarized.
Measured: Baseline up to 6 months post therapy
Change in physical activity levels
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.
Measured: Baseline up to 6 months post therapy
Change in QOL measures
Changes will be calculated as post-treatment scores minus pre-treatment scores. The pattern of changes in QOL measures will be summarized.
Measured: Baseline up to 6 months post therapy
Change in FCG-reported caregiving burden level and QOL scores
Changes will be calculated as post-treatment scores minus pre-treatment scores.
Measured: Baseline up to 6 months post therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start8 Mar 2019
- Primary completion17 Jun 2022
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Arya Amini, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902535
- Sponsor's protocol ID
- 18294
- Other IDs
- NCI-2018-02024, 18294, P30CA033572
- Status last verified
- Feb 2023
- First submitted
- 2 Apr 2019
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03902535
- Acronym / sponsor ID
- 18294
- Conditions
- Caregiver, Head and Neck Carcinoma, Lung Carcinoma, Metastatic Head and Neck Carcinoma, Metastatic Lung Carcinoma, Stage 0 Lung Cancer AJCC v8
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (geriatric and quality of life assessments) | – | Other: Comprehensive Geriatric Assessment, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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 (quality of life assessment) | – | Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationFamily caregivers complete quality of life assessment at baseline, and at 1, 3, and 6 months following patient radiation or CRT completion. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled to undergo upfront surgery or concurrent CRT for non-metastatic head and neck cancer and family caregivers
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Geriatric AssessmentComplete comprehensive geriatric assessment | Other | Group I (geriatric and quality of life assessments) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete quality of life assessment | Other | Group I (geriatric and quality of life assessments), Group II (quality of life assessment) |
| Questionnaire AdministrationComplete questionnaires | Other | Group I (geriatric and quality of life assessments), Group II (quality of life assessment) |
Primary outcome
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.
Physical activity levels
Time frame: Up to 6 months post therapy
Descriptive statistics will be used to summarize all physical activity levels.
Quality of life (QOL) measures
Time frame: Up to 6 months post therapy
Descriptive statistics will be used to summarize all QOL measures.
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.
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.
7 secondary outcomes
Percentage of patients with vulnerability using the geriatric assessment
Time frame: Up to 6 months post therapy
Percentage of patients who receive and accept referrals
Time frame: Up to 6 months post therapy
Treatment modification and healthcare utilization in patients
Time frame: Up to week 12
Change in CGA scores and domains
Time frame: Baseline up to 6 months post therapy
Change in physical activity levels
Time frame: Baseline up to 6 months post therapy
Change in QOL measures
Time frame: Baseline up to 6 months post therapy
Change in FCG-reported caregiving burden level and QOL scores
Time frame: Baseline up to 6 months post therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arya Amini principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caregiver and Head and Neck Carcinoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive geriatric assessment (CGA) scores and domains (time frame: Up to 6 months post therapy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.