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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

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

Other trials in United States

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

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 groups in NCT03902535
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.

8 Mar 201917 Jun 2022

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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