A Prospective Study of Physical Function in Adults Who Receive Systemic Therapy for Stage I-III Gastroesophageal Cancer, FAST-GO Study

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.

• Non-Interventional Study (Other), also known as Non-Interventional Observational Study, Noninterventional (Observational) Study: Non-interventional study

Primary outcomes

• 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.

Sex: All, ages: 18 Years to any

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.

• Jingran Ji, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center

NIH grants: R03AG095803