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

N/ANot Yet RecruitingNCT07517211

Jonsson Comprehensive Cancer Center72 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in SPPB

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.

Time frame: Through the end of cancer treatment, an average of 6 months