PRIMARY OBJECTIVE:
I. Compare the number of tumor-infiltrating immune CD8 Tcells. in surgical patients who receive Tele-PancFit (tele-supervised strengthening and remotely-monitored moderate intensity aerobic exercise) versus an enhanced usual care group who receive general recommendations for physical activity and receive an activity tracker.
SECONDARY OBJECTIVES:
I. Determine the effects of Tele-PancFit intervention on health-related quality of life (HRQOL) among patients with localized PC, including the change of the HRQOL over time and the between study groups.
II. Compare skeletal muscle maintenance indicated by skeletal muscle index (SMI) using computed tomography (CT) between patients in the exercise and usual care (UC) groups of the Tele-PancFit intervention.
III. Define the effects of Tele-PancFit participation on tumor vascular density and maturity among patients undergoing neoadjuvant chemotherapy for PC.
OTHER EXPLORATORY OBJECTIVES:
I. Determine the effects of the Tele-PancFit intervention on secondary physical function, symptom and body composition study measures.
II. Compare changes. between baseline, preoperative and postoperative timepoints within each study arm and between study arms of the following measures. Also compare outcome values between study arms at each data collection timepoint:
IIa. Skeletal muscle maintenance (skeletal muscle index [SMI] using routinely-obtained CT scans);
IIb. Skeletal muscle quality (skeletal muscle density [SMD] using routinely-obtained CT scans);
IIc. Visceral fat and subcutaneous fat using routinely-obtained CT scans;
IId. Muscle strength (1-repetition maximum [RM] chest press,1-RM leg press, 30 second chair stand test and 30 second arm curl test);
IIe. Muscle endurance;
IIf. Submaximal exercise capacity 6 minute walking test (6MWT);
IIg. Self-reported exercise (Modified Godin);
IIh. Self-reported physical functioning (Patient-Reported Outcomes Measurement Information System [PROMIS] Cancer Function);
IIi. Fatigue (Functional Assessment of Chronic Illness Therapy- Fatigue [FACIT-F]);
IIj. HRQOL (Functional Assessment of Cancer Therapy- Hepatobiliary [FACT-Hep]).
III. To compare levels of circulating tumor-associated and angiogenic factors such as CA 19-9, thrombospondin, CXCL12, IL-1b, VEGF, S1P between groups upon enrollment (T0), following administration of preoperative therapy (T1), and at postoperative visits (T2a/b).
IV. To compare cancer associated fibroblasts (CAFs), and tumor infiltrating immune cells between groups (among patients who have undergone surgical resection).
V. Determine the effects of the Tele-PancFit intervention on oncology treatment outcomes by comparing these measures in the Arms A and B:
Va. Compare the rate of initiation of adjuvant chemotherapy;
Vb. Completion of intended neoadjuvant therapy (NT) dose;
Vb. Dose reduction or change in NT treatment plan;
Vb. Time of initiation of adjuvant therapy (AT) after surgery;
Ve. Dose reduction or change in AT treatment plan;
Vf. Completion of AT (6 months total perioperative chemotherapy);
Vg. Incidence of perioperative adverse events that occur within 90 days between groups (Accordion score);
Vh. Hospital length of stay;
Vi. Acute cancer care center or emergency center visits within 30 days of surgery.
Vj. Event-free survival: time from randomization to first documentation of: 1) disease
progression; 2) R2 resection; 3) recurrent disease after surgery; or 4) death of any cause.
VI. Evaluate the effects of adherence to nutritional recommendations to body composition and physical function.
VII. Evaluate the effects of weight loss and sarcopenia status (yes/no) on body composition.
VIII. To assess the change in nutrition status (Patient-Generated Subjective Global Assessment short form [PGSGAsf]) along all study time points in all enrolled participants.
IX. To correlate the PGSGAsf score with the corresponding anthropometric measures at each time point for all participants.
X. To examine differences among Fitbit-measured physical activity and sleep between groups and associations among Fitbit variables and secondary endpoints between and within groups.
XI. To compare the 6MWT distance and secondary endpoints of participants within subgroups of patients who are stratified as “active” versus “insufficiently active” based on the Godin-Shephard Leisure Time Physical Activity Questionnaire.
XII. To compare the 6MWT distance and secondary endpoints of participants within subgroups of patients with different levels of physical activity (light, moderate, high intensity activity).
XIII. To explore the effect of sociodemographic variables (sex, age, race/ethnicity, zip code [for urban versus {vs} rural classification], distance from the hospital, marital status, insurance), need to borrow devices and wireless internet (Wi-Fi) connection on patient clinical outcomes and adherence to the activity prescription.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergoing neoadjuvant chemotherapy receive enhanced usual care on trial. Patients receive recommendations to remain physically active, wear a Fitbit activity device, and receive an instructional booklet on stretching and exercise utility and safety on trial. Patients undergo nutrition screening and receive recommendations based on malnutrition risk on trial. Patients also undergo CT scans and may undergo blood or tissue sample collection throughout the trial.
ARM B: Patients undergoing neoadjuvant chemotherapy participate in Tele-PancFit guided-exercise program that includes telemedicine RT sessions with a certified personal trainer as well as an independent aerobic exercise program and wear a Fitbit activity device on trial. Patients undergo nutrition screening and receive recommendations based on malnutrition risk, as well as education on daily protein goals on trial. Patients also undergo CT scans and may undergo blood or tissue sample collection throughout the trial.
