Clinical Stage I Esophageal Adenocarcinoma AJCC v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage I Gastric Cancer AJCC v8, Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage II Gastric Cancer AJCC v8, Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Conditions
Brief summary
This study evaluates how the treatment for gastroesophageal cancer affects physical function in patients who receive chemotherapy as part of their treatment for gastroesophageal cancer.
Detailed description
PRIMARY OBJECTIVE: I. To determine the change in physical function from baseline to 6 months of treatment, as measured by the short physical performance battery (SPPB). OUTLINE: This is an observational study. Patients undergo blood sample collection as well as complete surveys, physical function tests and may complete an interview on study.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
Jonsson Comprehensive Cancer Center
National Institute on Aging (NIA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \* Adults ≥ 18 years old at the start of study treatment. * New diagnosis of early-stage (Stage I, II, III) esophageal, gastroesophageal junction, or gastric adenocarcinoma, squamous cell carcinoma, or poorly differentiated carcinoma. * Plan to start systemic therapy for resectable or potentially resectable disease. * Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* \* Patients with stage I disease with plans to undergo endoscopic resection or surgery alone without perioperative systemic therapy. * Metastatic disease at the time of diagnosis. * Patients who are unable to provide informed consent. * Any condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures. * Currently participating in another intervention research study seeking to improve functional status, alleviate frailty, increase muscle strength, or improve cognitive function.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SPPB | Through the end of cancer treatment, an average of 6 months | Will characterize the levels of function at each time point and longitudinal changes in function using descriptive statistics (means, SDs, change scores) in the overall patient sample and by pre-treatment/treatment variables. To assess the associations between pre-treatment/treatment variables and change in function, we will use linear regression models with SPPB change score from baseline to 6 months as the dependent variable and pre-treatment demographic, clinical, and geriatric assessment characteristics as the predictor variables, controlling for the patient's pre-treatment level of function. Potential predictors will be examined individually and in a parsimonious multivariable model. We will also fit linear mixed models for each outcome variable using measurements at all time points and examine differences in change over time by pre-treatment/treatment variables using interaction terms. Time will be treated as a categorical variable, using indicator variables of time. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJingran Ji
UCLA / Jonsson Comprehensive Cancer Center
Outcome results
None listed